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Pfizer–BioNTech COVID-19 vaccine
INN: tozinameran
A vial of the Pfizer–BioNTech COVID‑19 vaccine
Vaccine description
TargetSARS-CoV-2
Vaccine typemRNA
Clinical data
Pronunciationtoe-zi-NA-mer-an
koe-MIR-na-tee
Trade namesComirnaty[1][2][3]
Other namesBNT162b2, COVID-19 mRNA vaccine (nucleoside-modified)
AHFS/Drugs.comMultum Consumer Information
MedlinePlusa621003
License data
Pregnancy
category
Routes of
administration		Intramuscular
ATC code
  • None
Legal status
Legal status
Identifiers
CAS Number
PubChem SID
DrugBank
UNII
KEGG
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The Pfizer–BioNTech COVID‑19 vaccine (pINN: tozinameran), sold under the brand name Comirnaty,[16] is an mRNA-based COVID-19 vaccine. The German company BioNTech is the developer of the vaccine, and partnered for support with clinical trials, logistics and manufacturing with American company Pfizer[17][18] as well as Chinese company Fosun for China.[19][20]

It is given by intramuscular injection. It is composed of nucleoside-modified mRNA (modRNA) encoding a mutated form of the spike protein of SARS-CoV-2, which is encapsulated in lipid nanoparticles.[21] The vaccination requires two doses given three weeks apart.[22][23][24] It is one of the two RNA vaccines deployed against COVID‑19 in 2020, the other being the Moderna COVID‑19 vaccine.

Clinical trials began in April 2020; by November the vaccine entered Phase III clinical trials, based on more than 40,000 people.[25] An interim analysis of study data showed a potential efficacy of over 90% in preventing infection within seven days of a second dose.[23][24] The most common side effects include mild to moderate pain at the injection site, fatigue, and headache.[26][27] Reports of serious side effects, such as allergic reactions, have been very rare,[a] and no long-term complications have been reported.[29][30] Monitoring of the primary outcomes from the trials will continue until August 2021, while monitoring of the secondary outcomes will continue until January 2023.[22]

It is both the first COVID-19 vaccine to be authorized by a stringent regulatory authority for emergency use[31][32] and the first cleared for regular use.[33] In December 2020, the United Kingdom was the first country to authorize the vaccine on an emergency basis,[29] soon followed by the United States, the European Union and several other countries globally.[34][35][8][36][37]

Globally, Pfizer and BioNTech aim to manufacture about 2 billion doses in 2021.[38] In China, the vaccine is manufactured and distributed by Fosun.[39] Pfizer has advanced purchase agreements of about US$3 billion for providing a licensed vaccine in the United States, the European Union, the United Kingdom, Japan, Canada, Peru, Singapore, and Mexico.[40][41] Distribution and storage of the vaccine is a logistical challenge because it needs to be stored at extremely low temperatures.[42]

Development and funding

Before COVID-19 vaccines, a vaccine for an infectious disease had never before been produced in less than several years, and no vaccine existed for preventing a coronavirus infection in humans.[43] The COVID-19 virus was detected in December 2019,[44] and BioNTech began development of a COVID-19 vaccine on 10 January 2020, when the SARS-CoV-2 genetic sequences were released by the Chinese Center for Disease Control and Prevention via GISAID,[45][46][47] triggering an urgent international response to prepare for an outbreak and hasten development of preventive vaccines.[48][49]

BioNTech started its program 'Project Lightspeed' to develop a vaccine against the new COVID‑19 virus based on its already established mRNA-technology.[25] 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.[50]

Funding

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.[39][51]

In April 2020, BioNTech signed a partnership with Pfizer and received $185 million, including an equity investment of approximately $113 million.[52][53]

In June 2020, BioNTech received €100 million (US$119 million) in financing from the European Commission and European Investment Bank.[54] In September 2020, the German government granted BioNTech €375 million (US$445 million) for its COVID‑19 vaccine development program.[55]

Pfizer CEO Albert Bourla said 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.[56]

Clinical trials

See also: COVID-19 vaccine § Clinical trials started in 2020
Cumulative incidence curves for symptomatic COVID‑19 infections after the first dose of the Pfizer–BioNTech vaccine (tozinameran) or placebo in a double-blind clinical trial. (red: placebo; blue: tozinameran)[57]

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.[25]

Preliminary results from Phase I–II clinical trials on BNT162b2, published in October 2020, indicated potential for its efficacy and safety.[21][58] During the same month, the European Medicines Agency (EMA) began a periodic review of BNT162b2.[59]

The study of BNT162b2 is a continuous-phase trial in Phase III as of November 2020.[22] It is a "randomized, placebo-controlled, observer-blind, dose-finding, vaccine candidate-selection, and efficacy study in healthy individuals".[22] The early-stage research 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.[24][39]

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.[22] For approval in the EU, an overall vaccine efficacy of 95% was confirmed by the EMA.[60] The EMA clarified that the second dose should be administered three weeks after the first dose.[61]

Vaccine efficacy – After dose 1 or 2 overall, and after dose 2 overall and by age groups[60]
Efficacy endpoint Vaccine efficacy (95% confidence interval) [%]
After dose 1 to before dose 2 52.4 (29.5, 68.4)
≥10 days after dose 1 to before dose 2 86.7 (68.6, 95.4)
Dose 2 to 7 days after dose 2 90.5 (61.0, 98.9)
≥7 days after dose 2 (subjects without evidence of infection prior to 7 days after dose 2)
Overall 95.0 (90.0, 97.9)
16–55 years 95.6 (89.4, 98.6)
≥55 years 93.7 (80.6, 98.8)
≥65 years 94.7 (66.7, 99.9)

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.[24][62][63]

The vaccine's ability to prevent severe infection in children, pregnant women, or immunocompromised people is unknown, as is the duration of the immune effect it confers.[24][62][63]

Pfizer and BioNTech started a Phase II/III randomized control trial in healthy pregnant women 18 years of age and older (NCT04754594).[64] The study will evaluate 30 µg of BNT162b2 or placebo administered via intramuscular injection in two doses, 21 days apart. The Phase II portion of the study will include approximately 350 pregnant women randomized 1:1 to receive BNT162b2 or placebo at 27 to 34 weeks' gestation. The Phase III portion of this study will assess the safety, tolerability, and immunogenicity of BNT162b2 or placebo among pregnant women enrolled at 24 to 34 weeks' gestation. Pfizer and BioNTech announced on 18 February 2021 that the first participants received their first dose in this trial.[65]

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.[66]

The vaccine candidate BNT162b2 was chosen as the most promising among three others with similar technology developed by BioNTech.[22][66][58] 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.[21][67] In these Phase I studies, BNT162b2 was shown to have a better safety profile than the other three BioNTech candidates.[67]

Sequence

The modRNA sequence of the vaccine is 4,284 nucleotides long.[68] It consists of a five-prime cap; a five prime untranslated region derived from the sequence of human alpha globin; a signal peptide (bases 55–102) and two proline substitutions (K986P and V987P, designated "2P") that cause the spike to adopt a prefusion-stabilized conformation reducing the membrane fusion ability, increasing expression and stimulating neutralizing antibodies;[21][69] a codon-optimized gene of the full-length spike protein of SARS-CoV-2 (bases 103–3879); followed by a three prime untranslated region (bases 3880–4174) combined from AES and mtRNR1 selected for increased protein expression and mRNA stability[70] and a poly(A) tail comprising 30 adenosine residues, a 10-nucleotide linker sequence, and 70 other adenosine residues (bases 4175–4284).[68] The sequence contains no uridine residues; they are replaced by 1-methyl-3'-pseudouridylyl.[68] The 2P proline substitutions in the spike proteins were originally developed for a MERS vaccine by researchers at the National Institute of Allergy and Infectious Diseases’ Vaccine Research Center, Scripps Research, and Jason McLellan’s team (at the University of Texas at Austin, previously at Dartmouth College).[69]

Composition

In addition to the mRNA molecule, the vaccine contains the following inactive ingredients (excipients):[71][72][10]

The first four of these are lipids. The lipids and modRNA together form nanoparticles. ALC-0159 is a polyethylene glycol conjugate, i.e. a PEGylated lipid.[73]

The vaccine is supplied in a multidose vial as "a white to off-white, sterile, preservative-free, frozen suspension for intramuscular injection".[13][14] It must be thawed to room temperature and diluted with normal saline before administration.[14]

Authorizations

Authorization and eligibility by country
  Full authorization
  Emergency authorization
  Eligible COVAX recipient


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 Medicines Act 1968.[133] It was the first COVID‑19 vaccine to be approved for national use after undergoing large scale trials,[134] and the first mRNA vaccine to be authorized for use in humans.[31][135] The United Kingdom thus became the first Western country to approve a COVID‑19 vaccine for national use,[136] although the decision to fast-track the vaccine was criticised by some experts.[137]

On 8 December 2020, Margaret "Maggie" Keenan, 90, from Fermanagh, became the first person to receive the vaccine.[138] In a notable example of museums documenting the pandemic, the vial and syringe used for that first dose were saved and acquired by The Science Museum in London for its permanent collection.[139] By 20 December, 521,594 UK residents had received the vaccine as part of the national vaccination programme. 70% had been to people aged 80 or over.[140]

After the United Kingdom, the following countries expedited processes to approve the Pfizer–BioNTech COVID‑19 vaccine for use: Argentina,[141] Australia,[142] Bahrain,[143] Canada,[9][144] Chile,[145] Costa Rica,[146] Ecuador,[145] Hong Kong,[147] Iraq,[148] Israel,[149] Jordan,[150] Kuwait,[151] Malaysia,[152] Mexico,[153] Oman,[154] Panama,[111] the Philippines,[155] Qatar,[156] Saudi Arabia,[37][157] Singapore,[158][159] South Korea,[160][161] the United Arab Emirates,[162] and the United States.[12]

The World Health Organization (WHO) authorized it for emergency use.[163]

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.[164] Following the EUA issuance, BioNTech and 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.[164][165][166] 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.[167][168]

On 16 February 2021, the South African Health Products Regulatory Authority (SAHPRA) in South Africa issues Section 21, Emergency Use Approval for the vaccine.[169][170]

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, saying the vaccine fully complied with the requirements of safety, efficacy and quality. This is the first authorization under a standard procedure.[1][171] On 23 December, a Lucerne resident, a 90-year-old woman, became the first person to receive the vaccine in Switzerland.[172] This marked the beginning of mass vaccination in continental Europe.[173]

On 21 December 2020, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommended granting conditional marketing authorization for the Pfizer–BioNTech COVID‑19 vaccine under the brand name Comirnaty.[2][174][175] The recommendation was accepted by the European Commission the same day.[174][176]

On February 23, 2021, the Brazilian Health Regulatory Agency approved the Pfizer–BioNTech COVID-19 vaccine under its standard marketing authorization procedure. It became the first COVID-19 vaccine to receive definitive registration rather than emergency use authorization in the country.[177]

Adverse effects

The adverse effect profile of the Pfizer–BioNTech COVID‑19 vaccine is similar to that of other adult vaccines.[24] During clinical trials, the side effects deemed very common[a] are (in order of frequency): pain and swelling at the injection site, tiredness, headache, muscle aches, chills, joint pain, and fever.[72] Fever is more common after the second dose.[72]

Severe allergic reaction has been observed in approximately eleven cases per million doses of vaccine administered.[178][179] According to a report by the US Centers for Disease Control and Prevention 71% of those allergic reactions happened within 15 minutes of vaccination and mostly (81%) among people with a documented history of allergies or allergic reactions.[178] The UK's Medicines and Healthcare products Regulatory Agency (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.[180][181][182] 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."[71]

The European Medicines Agency regularly reviews the data on the vaccine's safety.[30] In a report published on 4 March 2021 it concluded that "the benefits of Comirnaty in preventing COVID-19 continue to outweigh any risks, and there are no recommended changes regarding the use of this vaccine."[30]

Manufacturing

A US soldier holding the Pfizer-BioNTech vaccine

Pfizer and BioNTech are manufacturing the vaccine in their own facilities in the United States and in Europe. The license to distribute and manufacture in China was purchased by Fosun, alongside its investment in BioNTech.[18][39]

Manufacturing the vaccine requires a three-stage process. The first stage involves the molecular cloning of DNA plasmids that code for the spike protein by infusing them into Escherichia coli bacteria. For all markets, this stage is conducted in the United States,[183] at a small Pfizer pilot plant in Chesterfield, Missouri[184] (near St. Louis). 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.[185]

The second stage is being conducted at a Pfizer plant in Andover, Massachusetts[186] in the United States, and at BioNTech's plants in Germany.[183] The DNA is used as a template to build the desired mRNA strands,[185] which takes about four days.[183] 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 10 million doses. The bags are placed on special racks on trucks which take them to the next plant.[185]

The third stage is being conducted at Pfizer plants in Portage, Michigan[187] (near Kalamazoo) in the United States, and Puurs in Belgium. This stage involves combining the mRNA with lipid nanoparticles, then filling vials, boxing vials, and freezing them.[185] Croda International subsidiary Avanti Polar Lipids is providing the requisite lipids.[188] As of November 2020, the major bottleneck in the manufacturing process was combining mRNA with lipid nanoparticles.[185] At this stage, it takes only four days to go from mRNA and lipids to finished vials, but each lot must then spend several weeks in deep-freeze storage while undergoing verification against 40 quality-control measures.[183]

The Pfizer plant in Puurs is responsible for all vials for destinations outside the United States.[183] Therefore, all doses administered in the Americas outside of the United States have required at least two transatlantic flights (one to take DNA to Europe and one to bring back finished vaccine vials).[183]

In February 2021, Pfizer revealed that the entire sequence initially took about 110 days on average from start to finish, and that the company was making progress on reducing the time to 60 days.[189] More than half the days in the production process are dedicated to rigorous testing and quality assurance at each of the three stages.[189] Pfizer also revealed that the process requires 280 components and relies upon 25 suppliers located in 19 different countries.[183]

Vaccine manufacturers normally take several years to optimize the process of making a particular vaccine for speed and cost-effectiveness before attempting large-scale production.[189] Due to the urgency presented by the COVID-19 pandemic, Pfizer and BioNTech began production immediately with the process by which the vaccine had been originally formulated in the laboratory, then started to identify ways to safely speed up and scale up that process.[189]

BioNTech announced in September 2020 that it had signed an agreement to acquire from Novartis a manufacturing facility in Marburg, Germany, to expand their vaccine production capacity.[190] Once fully operational, the facility would produce up to 750 million doses per year, or more than 60 million doses per month. The site will be the third BioNTech facility in Europe which produces the vaccine, while Pfizer operates at least four production sites in the United States and Europe.[190]

Logistics

The vaccine is being delivered in vials that, once diluted, contain 2.25 ml of vaccine (0.45 ml frozen plus 1.8ml diluent).[166] According to the vial labels, each vial contains five 0.3 ml doses, however excess vaccine may be used for one, or possibly two, additional doses.[166][191] The use of low dead space syringes to obtain the additional doses is preferable, and partial doses within a vial should be discarded.[166][192] The Italian Medicines Agency officially authorized the use of excess doses remaining within single vials.[193] As of 8 January 2021, each vial contains six doses.[72][194][195][192] In the United States, vials will be counted as five doses when accompanied by regular syringes and as six doses when accompanied by low dead space syringes.[196]

Temperature the BioNTech-Pfizer vaccine must be kept at to ensure effectiveness, roughly between −80 and −60 °C (−112 and −76 °F)

The vaccine needs to be stored at temperatures between −80 and −60 °C (−112 and −76 °F),[42] until five days before vaccination[41][42] when it can be stored at 2 to 8 °C (36 to 46 °F), and up to two hours at temperatures up to 25 °C (77 °F)[197][13] or 30 °C (86 °F).[198][199] In February 2021, the U.S. Food and Drug Administration (FDA) updated the emergency use authorization (EUA) to permit undiluted frozen vials of the vaccine to be transported and stored at between −25 and −15 °C (−13 and 5 °F) for up to two weeks before use.[166][200][201]

Even high-income countries have limited 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.[41] The vaccine needs to be stored and transported at ultracold temperatures between −80 and −60 °C (−112 and −76 °F),[42][63][41][202][203] much lower than for the similar Moderna vaccine. The head of Indonesia's Bio Farma Honesti Basyir said 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 handle only temperatures between 2 and 8 °C (36 and 46 °F), far above the requirements of the vaccine.[204][205]

Advance orders

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.[24] In February 2021, BioNTech announced it would increase production by more than 50% to manufacture 2 billion doses in 2021.[206]

In July 2020, the vaccine development program Operation Warp Speed placed an advance order of US$1.95 billion with Pfizer to manufacture a 100 million doses of a COVID‑19 vaccine for use in the United States if the vaccine was shown to be safe and effective.[18][207][208][209] By mid-December 2020, Pfizer had agreements to supply 300 million doses to the European Union,[210] 120 million doses to Japan,[211] 40 million doses (10 million before 2021) to the United Kingdom,[63] 20 million doses to Canada,[212] an unspecified number of doses to Singapore,[213] and 34.4 million doses to Mexico.[214] Fosun also has agreements to supply 10 million doses to Hong Kong and Macau.[215] The Hong Kong government said it would receive its first batch of 1 million doses by the first quarter of 2021.[216]

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.[217]

In January 2021, Pfizer and BioNTech offered to supply 50 million doses of COVID‑19 vaccine for health workers across Africa between March and the end of 2021, at a discounted price of US$10 per dose.[218] In response South Africa has secured 20 million doses expected to be delivered in consignments after March.[219]

Name

BNT162b2 was the code name during development and testing,[21][220] tozinameran is the proposed international nonproprietary name (pINN),[221] and Comirnaty is the brand name.[1][2] According to BioNTech, the name Comirnaty "represents a combination of the terms COVID‑19, mRNA, community, and immunity".[222][223]

The vaccine also has the common name "COVID‑19 mRNA vaccine (nucleoside-modified)"[2] and may be distributed in packaging with the name Pfizer–BioNTech COVID‑19 Vaccine."[3]

Notes

  1. ^ a b According to the British National Formulary and MedDRA conventions, side effects are "very common" when they occur in more than 1 in 10 instances; "common", 1 in 100 to 1 in 10; "uncommon", 1 in 1,000 to 1 in 100; "rare", 1 in 10,000 to 1 in 1,000; and "very rare" when they occur in less than 1 in 10,000 instances.[28]
  2. ^ US authorization also includes the three sovereign nations in the Compact of Free Association: Palau, the Marshall Islands, and Micronesia.[125][126]

References

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  3. ^ a b "Comirnaty COVID-19 mRNA Vaccine". Comirnaty Global. Retrieved 31 December 2020.
  4. ^ "Comirnaty". Therapeutic Goods Administration (TGA). Retrieved 25 January 2021.
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Further reading

  • World Health Organization (2021). Background document on the mRNA vaccine BNT162b2 (Pfizer–BioNTech) against COVID-19: background document to the WHO interim recommendations for use of the Pfizer–BioNTech COVID-19 vaccine, BNT162b2, under emergency use listing, 14 January 2021 (Report). World Health Organization (WHO). hdl:10665/339218. WHO/2019-nCoV/vaccines/SAGE_recommendation/BNT162b2/background/2021.1.
Scholia has a profile for Pfizer–BioNTech COVID-19 vaccine (Q97154240).
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