The geek with a cynical view

Friday, February 26, 2021

On 20 February 2021, a Longtail Boeing 747-412BCF jet cargoliner, registration VQ-BWT, operating as flight 6T5504/LGT5504, had an engine failure above the village of Meerssen, shortly after taking off from Maastricht Aachen Airport on the way to John F. Kennedy International Airport. Dropped turbine blades from the exploded Pratt & Whitney PW4056 jet engine lightly injured two persons on the ground. The plane was able to land safely at Liège Airport.[4][5][6][7][8]

Dutch safety board is investigating

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United Airlines Flight 328

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United Airlines Flight 328 was a scheduled domestic passenger flight from Denver to Honolulu, Hawaii on February 20, 2021; the Boeing 777-222 operating the route on that date suffered an apparently contained engine failure shortly after takeoff,[1] that nevertheless resulted in a debris field at least 1 mile (1.6 km) wide over the Commons Park suburb of Broomfield, Colorado and surrounding area.[2][3][4][5][6] Falling debris from the affected engine cowling was recorded by eyewitnesses using smartphone cameras and a dash cam.[7][8][9]

The flight landed safely with no injuries or loss of life to those in the aircraft or on the ground.[10] Although the aircraft landed safely, the engine failure resulted in damage to the engine, an in-flight engine fire, and damage to the airplane.[11] The failed engine was a Pratt & Whitney model PW4077 turbofan.[12] The U.S. Federal Aviation Administration immediately issued an Emergency Airworthiness Directive requiring U.S. operators of airplanes equipped with similar Pratt & Whitney PW4000 series engines to inspect these engines' fan blades before further flight.[11] The U.S. National Transportation Safety Board is investigating the aircraft engine incident.

Contents

Aircraft

The aircraft involved was a Boeing 777-222 registered as N772UA (c/n 26930/Line no.5).[13] The aircraft was built in November 1994[14] and delivered to United in September 1995. The aircraft is fitted with two Pratt & Whitney PW4077 engines.[13]

Originally the aircraft started out as WA005, one of the original Boeing 777-200s that took part in the flight test certification program prior to its entry into commercial service.[15][14]

On the day of the incident the aircraft had arrived in Denver from Chicago O'Hare International Airport (ORD) as UA flight 2465, departing at 9:37 a.m. CST and arriving at 10:50 a.m. MST.[16]

Incident

United 328 departed from Denver International Airport's Runway 25 uneventfully at 12:15 local time,[17] but while climbing through 13,000 feet (4,000 m), there was an internal failure within the right engine. This resulted in some of the engine cowling becoming detached, causing it to fall to the ground, along with other engine parts. The pilots contacted air traffic control and the airliner subsequently landed safely at Runway 26 at 13:37 local time. No one on the ground or in the aircraft was injured, though flying debris resulted in a large hole in the wing to body fairing.[18][19]

Passengers were re-booked on UA flight 3025 – operated by a different Boeing 777, N773UA, a sister ship to N772UA immediately ahead of it on the production line[20] – that took off from DEN to HNL hours later. On February 13, 2018, originating from San Francisco as United Airlines Flight 1175, N773UA had a similar engine failure and loss of the engine cowling 120 miles from its destination of Honolulu, where it made a safe emergency landing.[21] Boeing has been working on a redesign for a replacement fan cowl as a result of that incident, according to documents reviewed by the Wall Street Journal.[22]

Another 777-289, JA8978, operated as Japan Air Lines Flight 904 from Okinawa-Naha Airport (OKA) on December 4, 2020, also experienced a similar fan blade out failure and partial loss of the fan cowl six minutes after takeoff;[23] it returned to OKA and landed safely, but the Japan Transport Safety Board considered it a “serious incident” and launched an investigation.[24]

Investigation

Photograph showing damage to the right engine cowling, including the loss of the inlet fairing and fan doors (NTSB photo)

The National Transportation Safety Board (NTSB) is investigating the incident.[9] A senior investigator living in the Denver area immediately coordinated with first responders. Three other investigators from the NTSB's Denver regional office are assisting. It was noted upon initial inspection that the inlet and the cowling had separated from the engine and that two fan blades had fractured, one near its root and an adjacent one about mid-span; a portion of one blade was embedded in the containment ring. The remainder of the fan blades exhibited damage to the tips and leading edges.[1]

On February 22, 2021, National Transportation Safety Board Chairman Robert Sumwalt announced that the damage to the fan blade is consistent with metal fatigue, according to a preliminary assessment.[25][26] It is unclear whether the failure is consistent with other failures attributed to metal fatigue in a fan blade in a February 2018 United Airlines flight and a December 2020 Japan Airlines flight.[25] Sumwalt also said that "by our strictest definition"[27] NTSB did not consider the incident an uncontained engine failure because "the containment ring contained the parts as they were flying out."[28] The NTSB will look into why the engine cowling separated from the aircraft and why there was a fire, despite indications that the fuel supply to the engine had been turned off.[25]

Pratt & Whitney PW4000

Damage to PW4000 hollow fan blades from UA328 (NTSB photo)

There have been previous reports of PW4000 engine failures. In December 2020, Japan Airlines Flight JL904 operating a Boeing 777 suffered a failure of the same engine type at around 16,000 to 17,000 feet.[29]

On February 13, 2018, United 1175 en route from San Francisco to Honolulu suffered from an engine failure over the Pacific. The aircraft was also a Boeing 777-222, N773UA, with an identical configuration to N772UA operating United 328. The aircraft subsequently landed safely in Honolulu with no injuries or loss of life. The NTSB eventually determined that the fan blade inside the engine fractured, leading to the failure.[21] The investigation faulted Pratt & Whitney for not doing more stringent inspections.[30] The aircraft was eventually repaired and returned to service.[21]

On the same day as United 328, a Boeing 747-400BCF belonging to Longtail Aviation experienced an uncontained engine failure, shortly after departing Maastricht Airport in the Netherlands.[31] Two people were injured by the falling debris.[32] The 747-400BCF was powered by PW4056 engines, an earlier version of the PW4000 engine.[31]

Reactions

After the accident of UA328, the Japanese Ministry of Land, Infrastructure, Transport and Tourism ordered the grounding of 32 Boeing 777 aircraft operated by Japan Airlines and All Nippon Airways.[33] The Federal Aviation Administration (FAA) ordered increased inspections of Boeing 777 aircraft with PW4000 engines;[34] United Airlines had preemptively removed all such airliners (of which it has 28 in storage, and 24 in use) from active service.[34][35]

On February 22, 2021, following an Emergency Airworthiness Directive, Boeing confirmed that it had grounded worldwide all 128 of its Boeing 777 aircraft equipped with certain Pratt & Whitney PW4000 engines because of the UA328 incident.[36] Later that day, the British Civil Aviation Authority also banned Boeing 777s powered by Pratt & Whitney PW4000-112 engines from entering UK airspace.[37][38]

On February 23, 2021, Pratt & Whitney released a statement that the company was cooperating with federal investigators and coordinating with operators and regulators to support a revised inspection interval of the PW4000 engines.[30]

Groundings by operator

As of 24 February 2021[39]

Airline In service In storage Total

United Airlines 24 28 52

All Nippon Airways 10 14 24

Japan Airlines 7 13 20

Korean Air 7 10 17

Asiana Airlines 6 1 7

Jin Air 4 0 4

Total 58 66 124

Monday, February 15, 2021

Ad26.COV2.S

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Ad26.COV2.S or JNJ-78436735 is a COVID-19 vaccine candidate developed by Janssen Vaccines, which is part of Johnson & Johnson (J&J) in the Netherlands and Beth Israel Deaconess Medical Center (BIDMC).[1] It is a human adenovirus viral vector vaccine.[2] On January 29, 2021, Janssen announced that it was 66% effective in a one-dose regimen in preventing symptomatic COVID-19, with an 85% efficacy in preventing severe COVID-19.[3][4][5] It can remain stable for an estimated timeframe of two years at -20°C (-4°F). The vaccine can be stored at least for three months in a refrigerator at temperatures of 2-8°C (36°F-46°F).[6]

Vaccine characteristics

The J&J vaccine can remain viable for months in a standard refrigerator.[7] Unlike the Pfizer–BioNTech COVID-19 vaccine and Moderna COVID-19 vaccine that previously received EUAs, the J&J COVID-19 vaccine is a single dose instead of two doses, and does not need to be shipped frozen.[8]

Development

Johnson & Johnson committed over US$1 billion toward the development of a not-for-profit COVID-19 vaccine in partnership with the Biomedical Advanced Research and Development Authority (BARDA) Office of the Assistant Secretary for Preparedness and Response (ASPR) at the U.S. Department of Health and Human Services (HHS).[9][10] J&J stated that its vaccine project would be "at a not-for-profit level" as the company viewed it as "the fastest and the best way to find all the collaborations in the world to make this happen."[11]

Janssen Vaccines, in partnership with Beth Israel Deaconess Medical Center (BIDMC), is responsible for developing the vaccine candidate, based on the same technology used to make its Ebola vaccine.

Clinical trials

Phase I-II

In June 2020, J&J and the National Institute of Allergy and Infectious Diseases (NIAID) confirmed its intention to start a clinical trials of J&J's vaccine in September 2020, with the possibility of Phase 1/2a human clinical trials starting at an accelerated pace in the second half of July.[12][13][14]

A Phase 1-2a clinical trial started with the recruitment of the first subject on July 15, 2020 and enrolled study participants in Belgium and the US. Interim results published from the Phase 1-2a trial established the safety, reactogenecity and immunogenecity of Ad26.COV2.S.[15][16]

Phase III

A Phase 3 clinical trial called ENSEMBLE started enrollment in September 2020 and completed enrollment on December 17, 2020. It was designed as a randomized, double-blind, placebo-controlled clinical trial designed to evaluate the safety and efficacy of a single-dose vaccine versus placebo in adults 18 years old and older. Study participants received a single intramuscular injection of Ad26.COV2.S at a dose level of 5×1010 virus particles on Day 1.[17] The trial was paused on October 12, 2020, because a volunteer became ill,[18] but the company said it found no evidence that the vaccine had caused the illness and announced on October 23, 2020 that it would resume the trial.[19][20] On January 29, 2021 Janssen announced safety and efficacy data from an interim analysis of ENSEMBLE trial data, which demonstrated the vaccine was 66% effective at preventing the combined endpoints of moderate and severe COVID-19 at 28 days post-vaccination among all volunteers. The interim analysis was based on 468 cases of symptomatic COVID-19 among 43,783 adult volunteers in Argentina, Brazil, Chile, Colombia, Mexico, Peru, South Africa, and the United States. No deaths related to COVID-19 were reported in the vaccine group, while 5 deaths in the placebo group were related to COVID-19.[6] During the trial, no anaphylaxis was observed in participants.[6]

A second Phase 3 clinical trial called ENSEMBLE 2 started enrollment on November 12, 2020. ENSEMBLE 2 differs from ENSEMBLE in that its study participants will receive two intramuscular (IM) injections of Ad26.COV2.S vaccine, one on Day 1 and the next on Day 57.[21]

Manufacturing

In April 2020, J&J entered a partnership with Catalent who will provide large-scale manufacturing of J&J's vaccine at Catalent's Bloomington, Indiana facility.[22] In July 2020, the partnership was expanded to include Catalent's Anagni, Italy facility.[23]

In July 2020, J&J pledged to deliver up to 300 million doses of its vaccine to the U.S., with 100 million upfront and an option for 200 million more. The deal, worth more than $1 billion, will be funded by the Biomedical Advanced Research and Development Authority (BARDA) and the U.S. Defense Department.[24][25] The deal was confirmed on 5 August.[26]

In September 2020, Grand River Aseptic Manufacturing agreed with J&J to support the manufacture of the vaccine, including technology transfer and fill and finish manufacture, at its Grand Rapids, Michigan facility.[27]

In December 2020 J&J and Reig Jofre, a Spanish pharmaceutical company, entered into an agreement to manufacture the vaccine at Reig Jofre's Barcelona facility.[28] If the European Medicines Agency grants approval to the vaccine by March 2021, a European Union regulator said that J&J could start supplying vaccines to EU countries starting on April 2021.[29][30]

In August 2020, J&J signed a contract with the U.S. federal government for US$1 billion, agreeing to deliver 100 million doses of the vaccine to the U.S. following the U.S. Food and Drug Administration (FDA) grant of approval or emergency use authorization (EUA) for the vaccine.[25] Under its agreement with the U.S. government, J&J was targeted to produce 12 million doses by the end of February 2021, more than 60 million doses by the end of April 2021, and more than 100 million doses by the end of June 2021. However, in January 2021, J&J acknowledged manufacturing delays would likely prevent it from meeting its contract of 12 million doses delivered to the U.S. by the end of February.[31]

Regulatory approval process

Beginning on December 1, 2020, clinical trial of the vaccine candidate has been undergoing a "rolling review" process by the European Medicines Agency's Committee for Medicinal Products for Human Use, a step to expedite EMA consideration of an expected conditional Marketing Authorisation Application.[29][32]

On February 4, 2021, J&J applied to the U.S. Food and Drug Administration (FDA) for an EUA, and the FDA announced that its Vaccines and Related Biological Products Advisory Committee would meet on February 26 to consider the application.[7][8][33] J&J previously announced that it planned to ship the vaccine immediately following authorization.[6]

On February 11, 2021, J&J first approval EUA from Saint Vincent and the Grenadines by the Government of Saint Vincent and the Grenadines.[34]

Impact

Given the J&J vaccine is a single dose and has a lower cost, it is expected that the vaccine will play an important role in low and middle-income countries.[35] With lower costs as well as requirements of storage and distribution in comparison to the COVID-19 vaccines by Pfizer and Moderna, the J&J vaccine will be more easily transported, stored, and administered.[36] South African health minister Zweli Mkhize announced on 9 February 2021 to sell or swap its one million doses of AstraZeneca vaccine. Mkhize said South Africa would begin using Ad26.COV2.S the week of 15 February.[37]

References

"Johnson & Johnson Initiates Pivotal Global Phase 3 Clinical Trial of Janssen's COVID-19 Vaccine Candidate". www.jnj.com. Retrieved 23 September 2020.

"A Study of Ad26.COV2.S for the Prevention of SARS-CoV-2-Mediated COVID-19 in Adult Participants (ENSEMBLE)". clinicaltrials.gov. Retrieved 30 January 2021.

Salzman, Sony (29 January 2021). "Johnson & Johnson single-shot vaccine 85% effective against severe COVID-19 disease". ABC News.

"Covid vaccine: Single dose Covid vaccine 66% effective". BBC News. 29 January 2021. Retrieved 29 January 2021.

Sohn R (29 January 2021). "J&J's Covid vaccine is 66% effective, a weapon but not a knockout punch". Stat. Retrieved 29 January 2021.

"Johnson & Johnson Announces Single-Shot Janssen COVID-19 Vaccine Candidate Met Primary Endpoints in Interim Analysis of its Phase 3 ENSEMBLE Trial". www.jnj.com. Retrieved 1 February 2021.

Carolyn Y. Johnson & Laurie McGinley (4 February 2021). "Johnson & Johnson seeks emergency FDA authorization for single-shot coronavirus vaccine". Washington Post.

Chander, Vishwadha (4 February 2021). "J&J files COVID-19 vaccine application with U.S. FDA". Reuters. Retrieved 4 February 2021.

Vecchione A (13 March 2020). "J&J collaborates to accelerate COVID-19 vaccine development". NJBIZ. Retrieved 22 April 2020.

"Prisma Health collaborates with Ethicon Inc. to make, distribute VESper Ventilator Expansion Splitter Device". WSPA 7News. 6 April 2020. Retrieved 22 April 2020.

"Coronavirus: Johnson & Johnson vows to make 'not-for-profit' vaccine". Sky News. Retrieved 22 April 2020.

Coleman J (10 June 2020). "Final testing stage for potential coronavirus vaccine set to begin in July". TheHill. Retrieved 11 June 2020.

"Moderna, AstraZeneca and J&J coronavirus shots rev up for NIH tests beginning in July: WSJ". FiercePharma. Retrieved 11 June 2020.

"Johnson & Johnson to start human testing of COVID-19 vaccine next week". FiercePharma. Retrieved 20 July 2020.

Sadoff, Jerald; et al. (13 January 2021). "Interim Results of a Phase 1–2a Trial of Ad26.COV2.S Covid-19 Vaccine". New England Journal of Medicine. doi:10.1056/NEJMoa2034201. PMC 7821985. PMID 33440088. Retrieved 30 January 2021.

"Johnson & Johnson COVID-19 Vaccine Candidate Interim Phase 1/2a Data Published in New England Journal of Medicine". www.jnj.com. Retrieved 16 January 2021.

"Fourth large-scale COVID-19 vaccine trial begins in the United States". www.nih.gov. Retrieved 30 January 2021.

Hughes V, Thomas K, Zimmer C, Wu KJ (12 October 2020). "Johnson & Johnson halts coronavirus vaccine trial because of sick volunteer". The New York Times. ISSN 0362-4331. Retrieved 12 October 2020.

"Johnson & Johnson Prepares to Resume Phase 3 ENSEMBLE Trial of its Janssen COVID-19 Vaccine Candidate in the U.S." Johnson & Johnson. 23 October 2020. Retrieved 28 October 2020.

Edwards E, Miller SG (23 October 2020). "AstraZeneca, Johnson & Johnson resume late-stage Covid-19 vaccine trials". NBC News. Retrieved 28 October 2020.

"A Study of Ad26.COV2.S for the Prevention of SARS-CoV-2-mediated COVID-19 in Adults (ENSEMBLE 2)". clinicaltrials.gov. Retrieved 30 January 2021.

Vecchione A (29 April 2020). "Catalent to lead US manufacturing for J&J's lead COVID-19 vaccine candidate". NJBIZ. Retrieved 13 November 2020.

"J&J expands COVID-19 vaccine pact with Catalent for finishing work at Italian facility". FiercePharma. Retrieved 13 November 2020.

"HHS, DOD Collaborate With Johnson & Johnson to Produce Millions of COVID-19 Investigational Vaccine Doses". HHS.gov (Press release). 5 August 2020. Retrieved 6 August 2020.

"Johnson & Johnson Announces Agreement with U.S. Government for 100 Million Doses of Investigational COVID-19 Vaccine". Johnson & Johnson (Press release). Retrieved 6 August 2020.

"US to Pay Johnson and Johnson $1 Billion for COVID-19 Vaccine". Voice of America. Retrieved 5 August 2020.

"Ramping Up COVID-19 Vaccine Fill and Finish Capacity". Contract Pharma. 3 November 2020.

Allen, Joan Faus, Nathan (15 December 2020). "Spain's Reig Jofre to manufacture J&J's COVID-19 vaccine, shares soar". Spain.

Guarascio, Francesco (13 January 2021). "J&J COVID-19 vaccine could be available in Europe in April: source". Reuters.

"EMA expected to approve Johnson & Johnson vaccine by March - CEO of Janssen Italy to paper". Reuters. 10 February 2021. Retrieved 13 February 2021.

Zimmer C, LaFraniere S, Weiland N (13 January 2021). "Johnson & Johnson Expects Vaccine Results Soon but Lags in Production". The New York Times.

"Johnson & Johnson Announces Initiation of Rolling Submission for its Single-dose Janssen COVID-19 Vaccine Candidate with the European Medicines Agency" (Press release). Johnson & Johnson. 1 December 2020.

"FDA Announces Advisory Committee Meeting to Discuss Janssen Biotech Inc.'s COVID-19 Vaccine Candidate" (Press release). U.S. Food & Drug Administration. 4 February 2021. Retrieved 4 February 2021.

"Public Health (Emergency Authorisation of COVID-19 Vaccine) Rules, 2021" (PDF). Government of Saint Vincent and the Grenadines. 11 February 2021. Retrieved 12 February 2021.

Grady, Denise (29 January 2021). "Which Covid Vaccine Should You Get? Experts Cite the Effect Against Severe Disease". The New York Times. ISSN 0362-4331. Retrieved 9 February 2021.

Brueck, Hilary. "Moderna vaccine creator calls Johnson & Johnson's competing shot a 'darn good' tool to fight the pandemic". Business Insider. Retrieved 9 February 2021.

Winning, Alexander; Roelf, Wendell (9 February 2021). "South Africa may sell AstraZeneca shots as it switches to J&J vaccine to fight variant". news.yahoo.com. Reuters. Retrieved 11 February 2021.

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Saturday, January 9, 2021

Sriwijaya Air Flight 182

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Sriwijaya Air Flight 182

From Wikipedia, the free encyclopedia

This article documents a recent aviation incident. Information may change rapidly as the event progresses, and initial news reports may be unreliable. The latest updates to this article may not reflect the most current information. Please feel free to improve this article (but note that updates without valid and reliable references will be removed) or discuss changes on the talk page. (January 2021) (Learn how and when to remove this template message)

Sriwijaya Air Flight 182

A shot of the plane pushing back, seen from the left side. Behind it is an Air Asia A320 parked at its gate.

PK-CLC, the aircraft involved in the accident,

in December 2017

Crash

Date 9 January 2021

Summary Crashed; under investigation (search ongoing)

Site Somewhere over Laki Island, Near Thousand Islands, Java Sea

05°57′36″S 106°34′30″ECoordinates: 05°57′36″S 106°34′30″E

Aircraft

Aircraft type Boeing 737-524

Aircraft name Citra

Operator Sriwijaya Air

IATA flight No. SJ182

ICAO flight No. SJY182

Call sign SRIWIJAYA 182

Registration PK-CLC

Flight origin Soekarno–Hatta International Airport, Jakarta, Indonesia

Destination Supadio International Airport, Pontianak, Indonesia

Occupants 62

Passengers 50

Crew 12[1][2][3]

Fatalities 62 (presumed)

Survivors 0 (presumed)

Sriwijaya Air Flight 182 (SJ182/SJY182) was a scheduled domestic passenger flight operated by Sriwijaya Air from Soekarno–Hatta International Airport, Jakarta, to Supadio International Airport, Pontianak, in Indonesia. On 9 January 2021, the Boeing 737–524 operating the flight disappeared from radar four minutes after departure. Officials confirmed that the aircraft crashed in the waters off the Thousand Islands, several kilometers from the airport. The search for the aircraft is ongoing.

Contents

Aircraft

The aircraft involved was a Boeing 737-524, registered as PK-CLC (MSN 27323/2616).[4] It was manufactured in 1994, and was first delivered to Continental Airlines the same year under the registration number N27610. The aircraft was acquired by United Airlines in 2010 when Continental and United merged. On 15 May 2012, United sold the aircraft to Sriwijaya Air. It was the first of a total of fifteen 737-500s received by Sriwijaya Air in 2012 to replace their 737-200s.[5] Sriwijaya Air named the aircraft "Citra". The aircraft was equipped with two CFMI CFM56-3B1 engines.[6]

The aircraft involved when it was in service with Continental Airlines in 2008 at Atlanta Hartsfield–Jackson Int'l, registered as N27610.

Flight details

Speed and altitude of Sriwijaya Air Flight 182

Route of Sriwijaya Air Flight 182

The aircraft was scheduled to take off from Soekarno–Hatta International Airport in Tangerang, Banten, at 14:10 WIB (7:10 UTC), and was scheduled to arrive at Supadio International Airport in Pontianak, West Kalimantan, at 15:40 WIB (8:40 UTC). After pushing back from the airport's Terminal 2D,[7] the aircraft took off from Runway 25R at 14:36 local time.[8] Due to the significant delay it was expected to land in Pontianak at 15:50 WIB (08:50 UTC).[7]

Flight 182 was climbing to 13,000 ft (4,000 m) when it abruptly swerved to the right and nosedived.[9] Air traffic controller (ATC) spotted this and asked the pilots to report their condition, but received no response.[10] According to AirNav Radarbox flight data, the aircraft reported a rapid drop in altitude during the climb phase from 10,900 ft (3,300 m) to 7,650 ft (2,330 m) at 07:40 UTC.[11] Flightradar24 reported that four minutes after takeoff, the aircraft dropped by 10,000 ft (3,000 m) in less than a minute.[12] The flight tracker noted that the last recorded altitude of the aircraft was 250 feet (76 m) at 07:40:27 UTC.[13] According to provided flight data, the plane experienced a drop of 1,755 ft (535 m) in just six seconds between 07:40:08 and 07:40:18 UTC. It was followed by a drop of 825 ft (251 m) in two seconds, 2,725 ft (831 m) in four seconds, and 5,150 ft (1,570 m) in its last seven seconds.[14] Its last contact with air traffic control was at 14:40 local time (07:40 UTC). The aircraft is presumed to have crashed into the Java Sea 19 kilometres (12 mi; 10 nmi) from Soekarno–Hatta International Airport,[15] specifically near Laki Island (Laki (Q4378768)).[16]

Passengers and crew

There were 62 people on board, with 50 being passengers, 6 being active crew members and 6 being non-active crew. Everyone on board is thought to be Indonesian.[1][2][3]

Among the passengers was Mulyadi Tamsir, a politician from Indonesia's People's Conscience Party.[17][18]

The active crew consisted of Captain Afwan, First Officer Diego M. and four flight attendants.[6][19] Afwan was a former pilot in the Indonesian Air Force.[20] The manifest which was released to the public indicated that another six crew members, including another captain and first officer, were also on board the aircraft.[21]

The cargo loaded in the aircraft was confirmed to be 500 kg (1,100 pounds).[22]

Search and rescue

Several eyewitness accounts were reported. A local fisherman reported that the aircraft crashed just 14 metres (46 ft) from his location. He stated that the aircraft exploded in mid-air. A piece of the aircraft was on fire and then fell to the sea.[23][24] Meanwhile, citizens of the Thousand Islands, near where the plane crashed, heard two explosions. It was raining in the area at the time.[25] The first report of a plane crash in the Thousand Islands was made at 14:30 local time, in which a fisherman stated that a plane had crashed and exploded in the sea.[26] At around 16:00 local time, eyewitnesses coordinated with firefighters to search for the aircraft.[25] The regent of the Thousand Islands, Junaedi, also reported that something fell and exploded on Laki Island.[27]

The head of the Indonesian National Search and Rescue Agency (Indonesian: BASARNAS), Bagus Puruhito, reported that the crash site was located 11 nautical miles (20 km) from Soekarno-Hatta International Airport.[28] Personnel from a vessel provided by the Ministry of Transportation reported that body parts, fragments of clothing, electronics, and wreckage had been recovered from the sea in waters near the Thousand Islands, with aviation fuel also reported around the location.[29][30] The water near the likely crash site has a depth of around 15–16 metres (49–52 ft).[31] BASARNAS immediately deployed personnel to the crash site[32] while the Indonesian National Police and the Ministry of Transportation set up crisis centers in Port of Tanjung Priok[33] and Soekarno–Hatta International Airport respectively.[34] The Indonesian Navy deployed a number of vessels for the SAR operations, in addition to helicopters and KOPASKA (frogman) personnel.[35]

Indonesian President Joko Widodo was immediately briefed on the accident. He ordered full coordination on the search and rescue operation and sent condolences to the relatives of the passengers and crew members.[36]

The Indonesian National Transportation Safety Committee (NTSC) reported that it will send the research ship Baruna Jaya to assist in the search and rescue operation. The vessel had been previously involved in search and rescue operations of multiple aviation accidents, including Lion Air Flight 610 and Indonesia AirAsia Flight 8501.[37] Meanwhile, the Indonesian Navy deployed seven ships and divers from the 1st Naval Regional Command to assist the search and rescue process.[38] Soon after, BASARNAS reported that the pings of the aircraft's Emergency Locator Transmitter (ELT) had not been detected.[39] It added that the search and rescue operation will be continued overnight, with the main focus on pinpointing the exact location of the crash site.[40] The exact crash location was later announced to the public.[41]

The Indonesian Red Cross deployed 50 volunteers and prepared at least 100 body bags for the victims of the accident.[42] Family members of the victims were asked to bring DNA samples and other antemortem information to the Disaster Victims Identification unit at Kramat Jati Hospital in Jakarta.[43] Accommodations for relatives were provided by Sriwijaya Air.[44]

On the night of 9 January, an emergency slide of the aircraft was recovered from the waters near Lancang Island, Thousand Islands.[45] Several other pieces of wreckage were recovered from the crash site; the search and rescue operation was hampered by low visibility.[46]

On 10 January, Minister of Transportation Budi Karya Sumadi alongside with the Commander of the Indonesian National Armed Forces Hadi Tjahjanto supervised the search and rescue operation on board the KRI John Lie 358.[47] Hadi Tjahjanto later stated that signals from the aircraft have been detected by the army.[48] Indonesian Navy announced that the exact coordinate of the crash site has been pinpointed.[49] The Indonesian Armed Forces stated that 4 teams of divers will be deployed to the site,[50] while the Indonesian Navy will deploy 150 personnel and helicopters to the crash site.[51]

Investigation

The Indonesian National Transportation Safety Committee (NTSC / Komite Nasional Keselamatan Transportasi; KNKT) was immediately notified of the accident, with assistance from BASARNAS. NTSC stated that, starting on 10 January, just before 6:00 am local time, search and rescue personnel will start searching for the aircraft's flight recorders.[52] It added that the investigation will be assisted by the US' National Transportation Safety Board.[53]

Adita Irawati, a spokeswoman from the Indonesian Ministry of Transportation, reported that an abnormality was noted during the flight. The aircraft departed Jakarta's Soekarno-Hatta International Airport with a standard instrument departure. The aircraft had been cleared to fly at 29,000 ft. During its flight climb phase, Flight 182 immediately went off course to the northwest. ATC later asked the crew about the incident, but a few seconds later the aircraft dropped from the radar.[54][55]

The director of Sriwijaya Air, Jefferson Irwin Jauwena, stated that the aircraft was airworthy, despite its age of 26 years. Although a 30-minute delay was noted, he insisted that the cause was bad weather, specifically heavy rain, rather than mechanical failure. In response, KNKT said that they would be coordinating with the Meteorology, Climatology, and Geophysical Agency (BMKG) in relation to weather in the Jakartan area.[56]

Indonesian aviation expert Alvin Lie stated that based on the preliminary data retrieved from aircraft, Flight 182 might have suffered a sudden failure that happened "so fast that pilots couldn't do anything". Data also indicated that there was not a single distress call or emergency call sent from the aircraft.[57]

Friday, January 1, 2021

AZD1222... 2021

AZD1222

Vaccine description

Target disease COVID-19

Type Modified chimpanzee adenovirus vector

Clinical data

Other names Covishield (India)[1]

Routes of

administration Intramuscular injection

Legal status

UK: Approved

Identifiers

CAS Number

2420395-83-9

PubChem SID

434150987

DrugBank

DB15656

UNII

B5S3K2V0G8

Part of a series on the

COVID-19 pandemic

SARS-CoV-2 without background.png

SARS-CoV-2 (virus)COVID-19 (disease)

Timeline[show]

Locations[show]

International response[show]

Medical response[show]

Impact[show]

SARS-CoV-2 (Wikimedia colors).svg COVID-19 Portal

vte

AZD1222, also known as ChAdOx1 nCoV-19, is a COVID-19 vaccine developed by Oxford University and AstraZeneca given by intramuscular injection, using as a vector the modified chimpanzee adenovirus ChAdOx1.[2][3][4][5]

The research is being done by the Oxford University's Jenner Institute and Oxford Vaccine Group. The team is led by Sarah Gilbert, Adrian Hill, Andrew Pollard, Teresa Lambe, Sandy Douglas and Catherine Green.[6][7]

As of December 2020, the vaccine candidate is undergoing Phase III clinical research.[8]

On 30 December 2020 the vaccine was approved for use[9] in the UK's vaccination programme.

Contents

Vaccine platform

The AZD1222 vaccine is a replication-deficient simian adenovirus vector, containing the full‐length codon‐optimized coding sequence of SARS-CoV-2 spike protein along with a tissue plasminogen activator (tPA) leader sequence.[10]

The researchers used the SARS-CoV-2 genome that had been sequenced in Wuhan. The modified monkey adenovirus cannot replicate, so does not cause further infection, and instead acts as a vector to transfer the SARS-CoV-2 spike protein.[11]

The spike S1 protein is an external protein that enables the SARS-type coronavirus to enter cells through the enzymatic domain of ACE2.[12] After vaccination, this spike protein is produced, promoting the immune system to attack the coronavirus if it later infects the body.[13]

History

In June 2020, the US National Institute of Allergy and Infectious Diseases (NIAID) confirmed that the third phase of testing for potential vaccines developed by Oxford University and AstraZeneca would begin in July 2020.[14]

In July 2020, AstraZeneca partnered with IQVIA to speed up US clinical trials.[15]

On 31 August 2020, AstraZeneca announced that it had begun enrolling adults for a US-funded, 30,000-subject late-stage study.[16]

On 8 September 2020, AstraZeneca announced a global halt to the vaccine trial while a possible adverse reaction in a participant in the United Kingdom was investigated.[17][18][19] On 13 September, AstraZeneca and the University of Oxford resumed clinical trials in the United Kingdom after regulators concluded it was safe to do so.[20] AstraZeneca was criticized for vaccine safety after concerns from experts noting the company's refusal to provide details about serious neurological illnesses in two participants who received the experimental vaccine in Britain.[21] While the trial resumed in the UK, Brazil, South Africa, Japan[22] and India, it remained on pause in the US till 23 October 2020[23] while the FDA investigated a patient illness that triggered the clinical hold, according to the HHS Secretary Alex Azar.[24]

On 15 October 2020, Dr João Pedro R. Feitosa, a 28-year-old doctor from Rio de Janeiro, Brazil, who received a placebo instead of the test vaccine in a clinical trial of AZD1222, died from COVID-19 complications.[25][26][27] The Brazilian health authority Anvisa announced that the trial would continue in Brazil.[28]

On 23 November 2020, Oxford University and AstraZeneca announced interim results from the vaccine's ongoing phase 3 trials.[13] There was criticism of the methods used in the report, which combined results of 62% and 90% from different groups of test subjects given different dosages to arrive at a 70% figure.[8][29][30] AstraZeneca said it would carry out a further multi-country trial using the lower dose which had led to a 90% claim.[31]

The full publication of these interim results, from four ongoing, blinded, randomised, controlled trials, on 8 December 2020, clarified these reports.[32] In the group who received the active vaccine more than 21 days earlier, there were no hospitalisations or severe disease, unlike those receiving the control vaccine. Serious adverse events were balanced across the active and control arms in the studies. One subject developed transverse myelitis 14 days after receiving the booster of the active vaccination, and other events occurred in the control group.[32]

On 11 December 2020, AstraZeneca announced they will explore with the Russian Gamaleya Research Institute whether their two adenovirus-based vaccines, AZD1222 and Gam-COVID-Vac, could be combined to give improved protection levels. Clinical trials are expected to start in Russia before the end of 2020.[33][34]

In December 2020, the chief executive of AstraZeneca, Pascal Soriot said he believed researchers have found a “winning formula” in form of the Oxford-AstraZeneca Covid-19 vaccine, where two doses were used. It was also revealed that the vaccine could be rolled out from 4 January 2021.[35]

Approval

On 27 November 2020, the UK government asked the Medicines and Healthcare products Regulatory Agency to assess the AZD1222 vaccine for temporary supply,[36] and it was approved for use on 30 December 2020, as their second vaccine to enter the national rollout.[37]

On 29 December, the Deputy Executive Director of the European Medicines Agency (EMA), Noel Wathion, stated that the EU regulator will most likely not be able to approve the vaccine until February. He said in an interview “They have not even filed an application with us yet".[38]

The vaccine has also been approved by Argentina[39], El Salvador[40] and India[41] regulatory authorities for emergency usage in their respective countries.

Production and supply

The vaccine is stable at refrigerator temperatures and costs around $3 to $4 per dose.[42] On 17 December a tweet by the Belgium Budget State Secretary revealed the EU would pay €1.78 per dose.[43]

According to AstraZeneca's vice-president for operations and IT, Pam Cheng, the company will have around 200 million doses ready worldwide by the end of 2020 and capacity to produce 100 million to 200 million doses per month once production is ramped up.[8]

In June 2020, further to making 100 million doses available to the UK's NHS, for their vaccination programme,[44] AstraZeneca and Emergent BioSolutions signed a US$87 million deal to manufacture doses of the vaccine specifically for the US market. The deal was part of the Trump administration's Operation Warp Speed initiative to develop and rapidly scale production of targeted vaccines before the end of 2020.[45] Catalent will be responsible for the finishing and packaging process.[46].The majority of manufacturing work will be done in the UK.

In June 2020, AstraZeneca and Serum Institute of India (SII) reached a licensing agreement to supply one billion doses of the Oxford University vaccine to middle and low income countries, including India.[47][48]

On 13 June 2020, AstraZeneca signed a contract with Europe's Inclusive Vaccines Alliance, a group formed by France, Germany, Italy and the Netherlands, to supply up to 400 million doses to all European Union member states.[49][50][51]

In August 2020, AstraZeneca agreed to provide 300 million doses to the US for US$1.2 billion, implying a cost of US$4 a dose. An AstraZeneca spokesman said the funding also covers development and clinical testing.[52]

In September 2020, AstraZeneca agreed to provide 20 million doses to Canada.[53][54]

In October 2020, Switzerland signed an agreement with AstraZeneca to pre-order up to 5.3 million doses.[55][56]

References

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"A Phase 2/3 study to determine the efficacy, safety and immunogenicity of the candidate Coronavirus Disease (COVID-19) vaccine ChAdOx1 nCoV-19". EU Clinical Trials Register (Registry). European Union. 21 April 2020. EudraCT 2020-001228-32. Archived from the original on 5 October 2020. Retrieved 3 August 2020.

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"Covid-19: Oxford-AstraZeneca coronavirus vaccine approved for use in UK". BBC News. BBC. 30 December 2020. Retrieved 30 December 2020.

Arashkia A, Jalilvand S, Mohajel N, Afchangi A, Azadmanesh K, Salehi-Vaziri M, et al. (2020). "Severe acute respiratory syndrome-coronavirus-2 spike (S) protein based vaccine candidates: State of the art and future prospects". Reviews in Medical Virology. n/a (n/a): e2183. doi:10.1002/rmv.2183. PMC 7646037.

"Exeter Fellow Dr Catherine Green leads the production of a potential COVID-19 vaccine in Oxford". Exeter College. 6 April 2020. Retrieved 24 April 2020.

Wang H, Yang P, Liu K, Guo F, Zhang Y, Zhang G, Jiang C (February 2008). "SARS coronavirus entry into host cells through a novel clathrin- and caveolae-independent endocytic pathway". Cell Research. 18 (2): 290–301. doi:10.1038/cr.2008.15. PMC 7091891. PMID 18227861.

"AZD1222 vaccine met primary efficacy endpoint in preventing COVID-19". www.astrazeneca.com. Retrieved 27 November 2020.

Coleman J (10 June 2020). "Final testing stage for potential coronavirus vaccine set to begin in July". TheHill. Retrieved 11 June 2020.

"AZN, IQV Team Up To Accelerate COVID-19 Vaccine Work, RIGL's ITP Drug Repurposed, IMV On Watch". RTTNews. Retrieved 15 July 2020.

"Phase 3 Clinical Testing in the US of AstraZeneca COVID-19 Vaccine Candidate Begins". National Institutes of Health (NIH). 30 August 2020. Retrieved 1 September 2020.

"AstraZeneca Covid-19 vaccine study is put on hold". STAT. 8 September 2020. Retrieved 10 September 2020.

"AstraZeneca Covid-19 vaccine study is put on hold". 8 September 2020.

Wu KJ, Thomas K (8 September 2020). "AstraZeneca Pauses Vaccine Trial for Safety Review". The New York Times. ISSN 0362-4331. Retrieved 10 September 2020.

Loftus P (13 September 2020). "AstraZeneca Covid-19 Vaccine Trials Resume in U.K." Wall Street Journal. ISSN 0099-9660. Retrieved 13 September 2020.

Grady D, Wu KJ, LaFraniere S (19 September 2020). "AstraZeneca, Under Fire for Vaccine Safety, Releases Trial Blueprints". The New York Times. ISSN 0362-4331. Retrieved 22 September 2020.

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"FDA authorises restart of the COVID-19 AZD1222 vaccine US Phase III trial". www.astrazeneca.com. Retrieved 1 December 2020.

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Robbins, Rebecca; Mueller, Benjamin (25 November 2020). "After Admitting Mistake, AstraZeneca Faces Difficult Questions About Its Vaccine". The New York Times. ISSN 0362-4331. Retrieved 27 November 2020.

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msdogfood@hotmail.com

Monday, December 21, 2020

Tozinameran[12] (INN), codenamed BNT162b2, and commonly known as the Pfizer–BioNTech COVID-19 vaccine, is a COVID-19 vaccine developed by BioNTech in cooperation with Pfizer. It i

msdogfood@hotmail.com

Tozinameran[12] (INN), codenamed BNT162b2, and commonly known as the Pfizer–BioNTech COVID-19 vaccine, is a COVID-19 vaccine developed by BioNTech in cooperation with Pfizer. It is both the first COVID-19 vaccine to be authorized by a stringent regulatory authority for emergency use[13][14] and the first cleared for regular use.[11]

It is given by intramuscular injection. It is an RNA vaccine composed of nucleoside-modified mRNA (modRNA) encoding a mutated form of the spike protein of SARS-CoV-2, which is encapsulated in lipid nanoparticles.[15][16] The vaccination requires two doses given three weeks apart.[17][18][19] Its ability to prevent severe infection in children, pregnant women, or immune-compromised people is unknown, as is the duration of the immune effect it confers.[19][20][21]

Trials began in April 2020; by November, the vaccine had been tested on more than 40,000 people.[22] An interim analysis of study data showed a potential efficacy of over 90% in preventing infection within seven days of a second dose.[18][19] The most common side effects include mild to moderate pain at the injection site, fatigue, and headache.[23][24] As of December 2020, reports of serious side effects, such as allergic reactions, have been very rare,[a] and no long-term complications have been reported.[26]

In December 2020, tozinameran was under evaluation for emergency use authorization (EUA) for widespread use by several medical regulators globally. Emergency authorization is required as its Phase III clinical trials are still ongoing: monitoring of the primary outcomes will continue until August 2021, while monitoring of the secondary outcomes will continue until January 2023.[17] The United Kingdom was the first country to authorize its use on an emergency basis.[26] Other countries followed within a week.[5][27][28] By 16 December, 138,000 people in Britain had received the vaccine as part of the national vaccination programme.[29]

BioNTech is the initial developer of the vaccine, which partnered with Pfizer for the developing, logistics, finances, overseeing the clinical trials, and for worldwide manufacturing, with the exception of China where the license to distribute and manufacture was purchased by Fosun, alongside its investment in BioNTech.[30][31] Distribution to Germany and Turkey (likely due to origins of BioNTech's founders) is by BioNTech itself.[32] Pfizer indicated in November 2020, that 50 million doses could be available globally by the end of 2020, with about 1.3 billion doses in 2021.[19] Pfizer has advanced purchase agreements of about US$3 billion for providing a licensed vaccine in the United States, European Union, United Kingdom, Japan, Canada, Peru, and Mexico.[33] Distribution and storage of the vaccine is a global logistics challenge because it needs to be stored at temperatures between −80 and −60 °C (−112 and −76 °F),[34] until hours before vaccination.[33][34]

Contents

Development and funding

A vaccine for an infectious disease has never before been produced in less than several years, and no vaccine exists for preventing a coronavirus infection in humans.[35] After the coronavirus was detected in December 2019,[36] the genetic sequence of COVID‑19 was published on 11 January 2020, triggering an urgent international response to prepare for an outbreak and hasten development of a preventive vaccine.[37][38] In January 2020, German biotech-company BioNtech started its program 'Lightspeed' to develop a vaccine against the new COVID-19 virus based on its already established mRNA-technology.[22] Several variants of the vaccine were created in their laboratories in Mainz, and 20 of those were presented to experts of the Paul-Ehrlich-Institute in Langen.[39] Phase I / II Trials were started in Germany on 23 April 2020, and in the U.S. on 4 May 2020, with four vaccine candidates entering clinical testing. The Initial Pivotal Phase II / III Trial with the lead vaccine candidate 'BNT162b2' began in July. The Phase III results indicating a 95% effectiveness of the developed vaccine were published on 18 November 2020.[22]

BioNTech received a US$135 million investment from Fosun in March 2020 in exchange for 1.58 million shares in BioNTech and the future development and marketing rights of BNT162b2 in China,[31] Hong Kong, Macau and Taiwan.[40]

In September 2020, the German government granted BioNTech €375 million (US$445 million) for its COVID-19 vaccine development program at a time when Pfizer funded its portion of development costs without government funding.[41] BioNTech had also received €100 million (US$119 million) in financing from the European Commission and European Investment Bank, with the funding agreement finalized in June 2020.[42]

Pfizer CEO Albert Bourla stated that he decided against taking funding from the US government's Operation Warp Speed for the development of the vaccine "because I wanted to liberate our scientists [from] any bureaucracy that comes with having to give reports and agree how we are going to spend the money in parallel or together, etc." Pfizer did enter into an agreement with the US for the eventual distribution of the vaccine, as with other countries.[43]

Vaccine technology

See also: RNA vaccine and COVID-19 vaccine § Technology platforms

The BioNTech technology for the BNT162b2 vaccine is based on use of nucleoside-modified mRNA (modRNA) which encodes part of the spike protein found on the surface of the SARS-CoV-2 coronavirus (COVID-19), triggering an immune response against infection by the virus protein.[44]

The vaccine candidate BNT162b2 was chosen as the most promising among three others with similar technology developed by BioNTech.[17][44][45] Prior to choosing BNT162b2, BioNTech and Pfizer had conducted Phase I trials on BNT162b1 in Germany and the United States, while Fosun performed a Phase I trial in China.[16][46] In these Phase I studies, BNT162b2 was shown to have a better safety profile than the other three BioNTech candidates.[46]

Sequence

The modRNA sequence of tozinameran is 4,284 nucleotides long, with a molecular weight of approximately 1388 kDa.[47][48] It consists of a five-prime cap; a five prime untranslated region derived from the sequence of human alpha globin; a signal peptide coding region (bases 55–102); an optimized sequence which encodes a mutated version of the spike protein of SARS-CoV-2, containing two proline substitutions (K986P and V987P, designated "2P") that cause it to adopt a shape that stimulates neutralizing antibodies (bases 103-3879);[15][49] the three prime untranslated region (bases 3880–4174); and a poly(A) tail comprising 30 adenosine residues, a 10-nucleotide linker sequence, and 70 other adenosine residues (bases 4175-4284).[48] The sequence contains no uridine residues; it is replaced by 1-methyl-3′-pseudouridine.[48]

Composition

The vaccine contains the following inactive ingredients (excipients):[50][3]

ALC-0315 = ((4-hydroxybutyl)azanediyl)bis(hexane-6,1-diyl)bis(2-hexyldecanoate)

ALC-0159 = 2-[(polyethylene glycol)-2000]-N,N-ditetradecylacetamide

1,2-distearoyl-sn-glycero-3-phosphocholine (DSPC)

cholesterol

dibasic sodium phosphate dihydrate

monobasic potassium phosphate

potassium chloride

sodium chloride

sucrose

water for injection

The first four of these are lipids. The lipids and modRNA together form nanoparticles. ALC-0159 is a polyethylene glycol conjugate (that is, a PEGylated lipid).[51]

The vaccine is supplied in a multidose vial as "a white to off-white, sterile, preservative-free, frozen suspension for intramuscular injection".[8][9] It must be thawed to room temperature and diluted with normal saline before administration.[9]

Clinical research

See also: COVID-19 vaccine § Clinical trials started in 2020

Preliminary results from Phase I–II clinical trials on BNT162b2, published in October 2020, indicated potential for its efficacy and safety.[15][45] During the same month, the European Medicines Agency (EMA) began a periodic review of BNT162b2.[52]

The study of BNT162b2 is a continuous-phase trial in Phase III as of November 2020.[17] It is a "randomized, placebo-controlled, observer-blind, dose-finding, vaccine candidate-selection, and efficacy study in healthy individuals".[17] The early-stage research on BNT162b2 determined the safety and dose level for two vaccine candidates, with the trial expanding during mid-2020 to assess efficacy and safety of BNT162b2 in greater numbers of participants, reaching tens of thousands of people receiving test vaccinations in multiple countries in collaboration with Pfizer and Fosun.[19][31]

The Phase III trial assesses the safety, efficacy, tolerability, and immunogenicity of BNT162b2 at a mid-dose level (two injections separated by 21 days) in three age groups: 12–15 years, 16–55 years or above 55 years.[17]

The ongoing Phase III trial, which is scheduled to run from 2020 to 2022, is designed to assess the ability of BNT162b2 to prevent severe infection, as well as the duration of immune effect.[19][20][21] Side effects include serious allergic reaction in those susceptible,[53] aches and fever.[19]

Authorizations

Expedited

The United Kingdom's Medicines and Healthcare products Regulatory Agency (MHRA) gave the vaccine "rapid temporary regulatory approval to address significant public health issues such as a pandemic" on 2 December 2020, which it is permitted to do under the 1968 Medicines Act.[54] It was the first COVID-19 vaccine to be approved for national use after undergoing large scale trials,[55] and the first mRNA vaccine to be authorized for use in humans.[13][56] The United Kingdom thus became the first Western country to approve a COVID-19 vaccine for national use,[57] although the decision to fast-track the vaccine was criticised by some experts.[58] On 8 December 2020, Margaret "Maggie" Keenan, 90, from Fermanagh, became the first person to receive the vaccine in the UK.[59] By 16 December, 138,000 British residents had received the vaccine as part of the national vaccination programme.[29]

In December, after the United Kingdom, the following countries expedited processes to approve the Pfizer-BioNTech COVID-19 vaccine for use: Bahrain,[60] Canada,[61][62] Mexico,[63] the United States,[7] Kuwait,[64] Singapore,[65] Jordan,[66] Oman,[67] Saudi Arabia, Ecuador, and Chile.[68][69][28]

In the United States, an emergency use authorization (EUA) is "a mechanism to facilitate the availability and use of medical countermeasures, including vaccines, during public health emergencies, such as the current COVID-19 pandemic", according to the FDA.[70] Following an EUA issuance, BioNTech-Pfizer are expected to continue the Phase III clinical trial to finalize safety and efficacy data, leading to application for licensure (approval) of the vaccine in the United States.[70][71][72] The United States Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP) approved recommendations for vaccination of those aged 16 years or older.[73][74]

Standard

On 19 December 2020, the Swiss Agency for Therapeutic Products (Swissmedic) approved the Pfizer-BioNTech COVID-19 vaccine for regular use, two months after receiving the application, stating that the vaccine fully complied with the requirements of safety, efficacy and quality. This is the first authorization under a standard procedure, as Swiss laws do not allow emergency approvals.[1][75]

On December 21, 2020, the European Medicines Agency (EMA) recommended granting conditional marketing authorization for tozinameran.[76][2] The recommendation was accepted by the European Commission shortly thereafter, with EMA director Emer Cooke confirming that despite the "conditional" qualifier, the vaccine was granted full authorization rather than for emergency or temporary use.[77]

Adverse events

As a result of two vaccinees who had severe anaphylactic reactions, the UK's MHRA advised on 9 December 2020 that people who have a history of "significant" allergic reaction should not receive the Pfizer-BioNTech COVID-19 vaccine.[78][79][80] On 12 December, the Canadian regulator followed suit, noting that: "Both individuals in the U.K. had a history of severe allergic reactions and carried adrenaline auto injectors. They both were treated and have recovered."[50]

As of 18 December, the US CDC stated that in their jurisdiction six cases of "severe allergic reaction" had been recorded from more than 250,000 vaccinations, and of those six only one person had a "history of vaccination reactions".[81]

Manufacturing

Pfizer is manufacturing the vaccine in its own facilities in a three-stage process. The first stage, conducted at a small pilot plant in St. Louis, involves the molecular cloning of DNA plasmids that code for the spike protein by infusing them into Escherichia coli bacteria. After four days of growth, the bacteria are killed and broken open, and the contents of their cells are purified over a week and a half to recover the desired DNA product. The DNA is stored in tiny bottles and frozen for shipment. Safely and quickly transporting the DNA at this stage is so important that Pfizer has used its company jet and helicopter to assist.[82]

The second stage is being conducted at plants in Andover, Massachusetts, and in Germany. The DNA is used as a template to build the desired mRNA strands. Once the mRNA has been created and purified, it is frozen in plastic bags about the size of a large shopping bag, of which each can hold up to 5 to 10 million doses. The bags are placed on special racks on trucks which take them to the next plant.[82]

The third stage is being conducted at plants in Kalamazoo, Michigan, and Puurs, Belgium. This stage involves combining the mRNA with lipid nanoparticles, then filling vials, boxing vials, and freezing them.[82] Croda International subsidiary Avanti Polar Lipids is providing the requisite lipids.[83] As of mid-November 2020, the major bottleneck in the manufacturing process was combining mRNA with lipid nanoparticles.[82]

Advance orders and logistics

See also: COVID-19 vaccine § Supply chain

The first doses of the vaccine in December 2020 are being manufactured at a Pfizer-owned production plant in Puurs, Belgium.[84]

Pfizer indicated in its 9 November press release that 50 million doses could be available by the end of 2020, with about 1.3 billion doses provided globally by 2021.[19] In July 2020, the vaccine development program Operation Warp Speed had placed an advance order of US$2 billion with Pfizer to manufacture 100 million doses of a COVID-19 vaccine for use in the United States if the vaccine is shown to be safe and effective.[85][86][87] On 9 November, the Pfizer-BioNTech partnership announced that the company is a supplier of a COVID-19 vaccine if proven to be successful and licensed.[30]

Pfizer also has agreements to supply 300 million doses to the European Union,[88] 120 million doses to Japan,[89] 40 million doses (10 million before 2021) to the United Kingdom,[21] 20 million doses to Canada,[90] and 34.4 million doses to Mexico.[91] Fosun also has agreements to supply 10 million doses to Hong Kong and Macau.[92] The Hong Kong government said it would receive its first batch of one million doses by the first quarter of 2021.[93]

BioNTech and Fosun agreed to supply Mainland China with a batch of 100 million doses in 2021, subject to regulatory approval. The initial supply will be delivered from BioNTech's production facilities in Germany.[94]

In total, only affluent countries have preorder agreements with Pfizer in 2020, and even those countries have meager or non-existent cold chain capacity for ultracold transport and storage of a vaccine that degrades within five days when thawed, and requires two shots three weeks apart.[33] The vaccine needs to be stored and transported at ultracold temperatures between −80 and −60 °C (−112 and −76 °F).[34][21][33][95][96] The head of Indonesia's Bio Farma Honesti Basyir stated that purchasing the vaccine is out of the question for the world's fourth-most populous country, given that it did not have the necessary cold chain capability. Similarly, India's existing cold chain network can only handle temperatures between 2 and 8 °C (36 and 46 °F), far above the requirements of the vaccine.[97][98]

References

According to the British National Formulary, "very rare" applies when side effects occur in less than 1 in 10,000 instances.[25]

"Swissmedic grants authorisation for the first COVID-19 vaccine in Switzerland" (Press release). Swiss Agency for Therapeutic Products (Swissmedic). 19 December 2020. Retrieved 19 December 2020.

"Comirnaty: Pending EC decision". European Medicines Agency (EMA). 21 December 2020. Retrieved 21 December 2020.

https://www.ema.europa.eu/en/documents/product-information/comirnaty-product-information-approved-chmp-21-december-2020-pending-endorsement-european-commission_en.pdf

"Regulatory Decision Summary - Pfizer-BioNTech COVID-19 Vaccine". Health Canada. 9 December 2020. Retrieved 13 December 2020.

"Regulatory Decision Summary - Pfizer-BioNTech COVID-19 Vaccine". Health Canada. 9 December 2020. Archived from the original on 9 December 2020. Retrieved 9 December 2020.

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《Fosun Pharma and BioNTech form COVID-19 vaccine strategic alliance in China》（Fosun Phrama News Content , 15 March 2020）

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External links

Scholia has a profile for tozinameran (Q97154240).

"Tozinameran". Drug Information Portal. U.S. National Library of Medicine.

Global Information About Pfizer‑BioNTech COVID‑19 Vaccine (also known as BNT162b2)

A phase 1/2/3, placebo-controlled, randomized, observer-blind, dose-finding study to evaluate the safety, tolerability, immunogenicity, and efficacy of SARS-COV-2 RNA vaccine candidates against COVID`-19 in healthy individuals Original study protocol (by Pfizer)

Pfizer and BioNTech Announce Vaccine Candidate Against COVID-19 Achieved Success in First Interim Analysis from Phase 3 Study（press release by Pfizer, 2020-11-09）

Information for UK Healthcare Professionals on COVID-19 mRNA Vaccine BNT162b2 concentrate for solution for injection

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Tozinameran[12] (INN), codenamed BNT162b2, and commonly known as the Pfizer–BioNTech COVID-19 vaccine, is a COVID-19 vaccine developed by BioNTech in cooperation with Pfizer. It i

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