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==Contraindications==
==Contraindications==
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.<ref name=mhra-allergy>{{cite web |first = Nick | last = Bostock |publisher=GP |title=MHRA warning after allergic reactions in NHS staff given COVID-19 vaccine |url=https://www.gponline.com/mhra-warning-allergic-reactions-nhs-staff-given-covid-19-vaccine/article/1702322 |date=9 December 2020 |access-date=9 December 2020 |archive-date=9 December 2020 |archive-url=https://web.archive.org/web/20201209163321/https://www.gponline.com/mhra-warning-allergic-reactions-nhs-staff-given-covid-19-vaccine/article/1702322 |url-status=live |name-list-style=vanc }}</ref><ref name="WP-20201209">{{cite news |last1=Booth |first1=William |last2=Cunningham |first2=Erin |title=Britain warns against Pfizer vaccine for people with history of 'significant' allergic reactions |url=https://www.washingtonpost.com/world/pfizer-allergic-warnings-vaccine/2020/12/09/4e79ec72-3a16-11eb-aad9-8959227280c4_story.html |date=9 December 2020 |work=[[The Washington Post]] |access-date=9 December 2020 |archive-date=9 December 2020 |archive-url=https://web.archive.org/web/20201209195847/https://www.washingtonpost.com/world/pfizer-allergic-warnings-vaccine/2020/12/09/4e79ec72-3a16-11eb-aad9-8959227280c4_story.html |url-status=live }}</ref><ref name=akdis20/> 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."<ref name="hc12dec">{{cite web |title=Pfizer-BioNTech COVID-19 vaccine: Health Canada recommendations for people with serious allergies |url=https://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2020/74543a-eng.php |publisher=Health Canada |date=12 December 2020}}</ref>
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.<ref name=mhra-allergy>{{cite web |first = Nick | last = Bostock |publisher=GP |title=MHRA warning after allergic reactions in NHS staff given COVID-19 vaccine |url=https://www.gponline.com/mhra-warning-allergic-reactions-nhs-staff-given-covid-19-vaccine/article/1702322 |date=9 December 2020 |access-date=9 December 2020 |archive-date=9 December 2020 |archive-url=https://web.archive.org/web/20201209163321/https://www.gponline.com/mhra-warning-allergic-reactions-nhs-staff-given-covid-19-vaccine/article/1702322 |url-status=live |name-list-style=vanc }}</ref><ref name="WP-20201209">{{cite news |last1=Booth |first1=William |last2=Cunningham |first2=Erin |title=Britain warns against Pfizer vaccine for people with history of 'significant' allergic reactions |url=https://www.washingtonpost.com/world/pfizer-allergic-warnings-vaccine/2020/12/09/4e79ec72-3a16-11eb-aad9-8959227280c4_story.html |date=9 December 2020 |work=[[The Washington Post]] |access-date=9 December 2020 |archive-date=9 December 2020 |archive-url=https://web.archive.org/web/20201209195847/https://www.washingtonpost.com/world/pfizer-allergic-warnings-vaccine/2020/12/09/4e79ec72-3a16-11eb-aad9-8959227280c4_story.html |url-status=live }}</ref><ref name="cekdis20">{{cite journal |doi=10.1111/all.14711|title=Allergic reactions to the first COVID‐19 vaccine: A potential role of Polyethylene glycol?|year=2020|last1=Cabanillas|first1=Beatriz|last2=Akdis|first2=Cezmi|last3=Novak|first3=Natalija|journal=Allergy|pmid=33320974|s2cid=229284320}}</ref> 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."<ref name="hc12dec">{{cite web |title=Pfizer-BioNTech COVID-19 vaccine: Health Canada recommendations for people with serious allergies |url=https://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2020/74543a-eng.php |publisher=Health Canada |date=12 December 2020}}</ref>


== Manufacturing ==
== Manufacturing ==

Revision as of 14:44, 21 December 2020

Pfizer–BioNTech COVID-19 vaccine
A vial of Pfizer–BioNTech COVID-19 Vaccine
Vaccine description
TargetCOVID-19
Vaccine typemRNA
Clinical data
Trade namesPfizer–BioNTech COVID-19 Vaccine, Comirnaty[1]
Other namesBNT162b2
License data
Routes of
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UNII
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Molar mass~1388 kDa
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Tozinameran[9] (INN), codenamed BNT162b2 and more commonly known as the Pfizer-BioNTech COVID-19 vaccine, is a COVID-19 vaccine developed by BioNTech and Pfizer[10] and manufactured and distributed by Pfizer, Fosun Pharmaceutical and BioNTech itself. It is both the first COVID-19 vaccine to be authorized by a stringent regulatory authority for emergency use[11][12] and also the first cleared for regular use.[8]

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.[13][14] The vaccination requires two doses given three weeks apart.[15][16][17] 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.[17][18][19]

Trials began in April 2020; by November, the vaccine had already been tested on more than 40,000 people.[20] At this point, an interim analysis of study data showed a potential efficacy of over 90% in preventing infection within seven days of a second dose.[16][17][21][22] 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 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.[15] The United Kingdom was the first country to authorize its use on an emergency basis.[26] Bahrain,[27] Canada,[28] Saudi Arabia,[29] Mexico,[30] the United States,[31] Singapore,[32] and Kuwait [33] followed. By 16 December, 138,000 people in Britain had received the vaccine as part of the national vaccination programme.[34]

BioNTech is the initial developer of the vaccine, which partnered with Pfizer for the developing, logistics, finances, overseeing the clinical trials, and for manufacturing BNT162b2 worldwide, with the exception of China where the license to distribute and manufacture was purchased by Fosun.[35][36] The distribution to Germany and Turkey is by BioNTech itself.[37] 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.[17] 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.[38] Distribution and storage of BNT162b2 is a global logistics challenge because the mRNA vaccine needs to be stored at temperatures between −80 and −60 °C (−112 and −76 °F),[39] until hours before vaccination.[38][39]

Development and funding

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.[20] 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.[40] 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.[20]

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,[36] Hong Kong, Macau and Taiwan.[41]

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.[42] 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.[43]

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.[44]

Vaccine technology

See also: RNA vaccine
See also: 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.[45]

The vaccine candidate BNT162b2 was chosen as the most promising among three others with similar technology developed by BioNTech.[15][45][46] 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.[14][47] In these Phase I studies, BNT162b2 was shown to have a better safety profile than the other three BioNTech candidates.[47]

Sequence

The modRNA sequence of tozinameran is 4,284 nucleotides long, with a molecular weight of approximately 1388 kDa.[48][49] 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);[13][50] 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).[49] The sequence contains no uridine residues; it is replaced by 1-methyl-3′-pseudouridine.[49]

Composition

The Canadian regulator lists the following ingredients for the product:[51]

BNT162b2 is delivered as "a white to off-white, sterile, preservative-free, frozen suspension for intramuscular injection".[6][7] As well as the modRNA encoding the spike protein of SARS-CoV-2, it contains four lipids, at least one of which needs formulation with polyethylene glycol (PEG):

The lipids and modRNA together form lipid nanoparticles. ALC-0159 is a PEG/lipid conjugate (i.e. PEGylated lipid).[53]

The vaccine also contains potassium chloride, monobasic potassium phosphate, sodium chloride, dibasic sodium phosphate dihydrate, and sucrose. The vaccine is supplied in a multi-dose vial and must be unfrozen and diluted with normal saline before injection.[7]

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.[13][46] During the same month, the European Medicines Agency began a periodic review of BNT162b2.[54]

The study of BNT162b2 is a continuous-phase trial in Phase III as of November 2020.[15] It is a "randomized, placebo-controlled, observer-blind, dose-finding, vaccine candidate-selection, and efficacy study in healthy individuals".[15] 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.[17][36]

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.[15]

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.[17][18][19] Side effects include serious allergic reaction in those susceptible,[55] aches and fever.[17]

Authorizations

Emergency use authorization

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.[56] 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 Pfizer-BioNTech COVID-19 Vaccine in the United States.[56][57][58]

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.[59] It was the first COVID-19 vaccine to be approved for national use after undergoing large scale trials,[60] and the first mRNA vaccine to be authorized for use in humans.[11][61] The United Kingdom thus became the first Western country to approve a COVID-19 vaccine for national use,[62] although the decision to fast-track the vaccine was criticised by some experts.[63]

On 8 December 2020, Margaret "Maggie" Keenan, 90, from Fermanagh, became the first person to receive the vaccine in the UK.[64] By 16 December, 138,000 British residents had received the vaccine as part of the national vaccination programme.[34]

In December, after the United Kingdom, the following countries approved the Pfizer-BioNTech COVID-19 vaccine for emergency use: Bahrain,[65] Canada,[66][67] Mexico,[68] the United States,[5] Kuwait,[69] Singapore,[70] Jordan,[71] Oman,[72] Saudi Arabia, Ecuador, and Chile.[73][74][75][28][30][76][33] 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.[77][78]

On 21 December 2020, the European Medicines Agency (EMA) authorized the vaccine for use all across the EU. [79]

Standard authorization

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][80]

Contraindications

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.[81][82][83] 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."[51]

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.[84]

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.[84]

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.[84] Croda International subsidiary Avanti Polar Lipids is providing the requisite lipids.[85] As of mid-November 2020, the major bottleneck in the manufacturing process was combining mRNA with lipid nanoparticles.[84]

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.[86]

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.[17] 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.[87][88][89] 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.[35]

Pfizer also has agreements to supply 300 million doses to the European Union,[90] 120 million doses to Japan,[91] 40 million doses (10 million before 2021) to the United Kingdom,[19] 20 million doses to Canada,[92] and 34.4 million doses to Mexico.[93] Fosun also has agreements to supply 10 million doses to Hong Kong and Macau.[94] The Hong Kong government said it would receive its first batch of one million doses by the first quarter of 2021.[95]

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.[96]

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.[38] The vaccine needs to be stored and transported at ultracold temperatures between −80 and −60 °C (−112 and −76 °F).[39][19][38][97][98] 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.[99][100]

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