Before COVID19 vaccines, creating a vaccine for an infectious disease from scratch had never before been produced in less than the five years it had taken in 1967 when Maurice Hilleman had set the modern record with a vaccine for mumps, followed by the vaccine for Ebola also taking five years. As of 2019 no vaccine existed for preventing a
coronavirus infection in humans. The
SARS-CoV-2 virus, which causes COVID19, was detected in December 2019, The development of the Pfizer- BioNTech COVID19 vaccine began when BioNTech founder and CEO
Uğur Şahin while at his home in Mainz on Friday 24 January 2020, was checking out his regular websites when he noted a report in the science section of Der Spiegel website about a novel respiratory illness that had affected approximately 50 people in Wuhan. The authors of the submission were of the opinion that they were observing the early stages of an epidemic, While the company had a small team which had started developing vaccines for infectious disease and had been collaborating with Pfizer on a flu vaccine, BioNTech was after 11 years of financial losses totalling more than €400 million, concentrating its efforts on developing mRNA as a means of fighting cancer. Şahin had a series of meetings with the company's few infectious experts and the leaders of most of the departments to discuss his concerns about the virus and to announce his decision to establish a new project called 'Lightspeed' that would use all of the company's available resources to develop a vaccine. Using the genetic sequences that were available on Virological.org a team at BioNTech led by Stephanie Hein used gene synthesis to create DNA hardcopies, which were to be used to create the templates to make the mRNA. These hardcopies each contained up to 4,000 nucleotides, which were assembled from 50 to 80 smaller building blocks. After a few phone calls, Bourla agreed that Pfizer would work with BioNTech on the development of BioNTech's COVID-19 vaccine. However it wasn't until January 2021 that the formal commercial agreement between Pfizer and BioNTech for the COVID-19 vaccine was signed. BioNTech received a investment from Fosun on 16 March 2020, in exchange for 1.58million shares in BioNTech and the future development and marketing rights of BNT162b2 in China and surrounding territories. In April 2020, BioNTech signed a partnership with Pfizer and received $185million, including an equity investment of approximately $113million. The Bank's deal with BioNTech started early in the pandemic, when the Bank's staff reviewed its portfolio and came up with BioNTech as one of the companies capable of developing a COVID19 vaccine. The European Investment Bank had already signed a first transaction with BioNTech in 2019. In September 2020, the German government granted BioNTech () for its COVID19 vaccine development program. 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.
Clinical trials PhaseI–II Trials were started in Germany on 23 April 2020, and in the U.S. on 4May 2020, with four vaccine candidates entering clinical testing. The Pivotal PhaseII–III Trial with the lead vaccine candidate "BNT162b2" began in July. Preliminary results from
PhaseI–II clinical trials on BNT162b2, published in October 2020, indicated potential for its safety and efficacy. The study of BNT162b2 is a continuous-phase
trial in
phaseIII as of November 2020. The EMA clarified that the second dose should be administered three weeks after the first dose. At 14 days after dose 1, the cumulative incidence begins to diverge between the vaccinated group and the placebo group. The highest concentration of neutralizing antibodies is reached 7 days after dose 2 in younger adults and 14 days after dose 2 in older adults. High
antibody activity persists for at least three months after the second dose, with an estimated antibody
half-life of 55 days. From these data, one study suggested that antibodies might remain detectable for around 554 days.
Specific populations Pfizer and BioNTech started a PhaseII–III randomized control trial in healthy pregnant women 18 years of age and older (NCT04754594). In January 2021, Pfizer said it had finished enrolling 2,259 children aged between 12 and 15 years to study the vaccine's safety and efficacy. On 31 March 2021, Pfizer and BioNTech announced from initial PhaseIII trial data that the vaccine is 100% effective for those aged 12 to 15 years of age, with trials for those younger still in progress. A research letter published in
JAMA reported that the vaccines appeared to be safe for immunosuppressed organ transplant recipients, but that the resulting antibody response was considerably poorer than in the non-immunocompromised population after only one dose. The paper admitted the limitation of only reviewing the data following the first dose of a two-dose cycle vaccine. In November 2021, journalist
Paul D. Thacker alleged there has been "poor practice" at
Ventavia, one of the companies involved in the
phase III evaluation trials of the Pfizer vaccine. The report was enthusiastically embraced by
anti-vaccination activists.
David Gorski commented that Thacker's article presented facts without necessary context to misleading effect, playing up the seriousness of the noted problems.
Authorizations Although jointly developed with Pfizer, Comirnaty is based on BioNTech's proprietary mRNA technology, and the first
mRNA vaccine to be authorized for use in humans. The United Kingdom thus became the first
Western country to approve a COVID19 vaccine for national use, although the decision to fast-track the vaccine was criticized by some experts. After the United Kingdom, the following countries and regions expedited processes to approve the Pfizer–BioNTech COVID19 vaccine for use: Argentina, Australia, Bahrain, Canada, Chile, Costa Rica, Ecuador, Iraq, Israel, Jordan, Kuwait, Malaysia, Mexico, Oman, Panama, the Philippines, Qatar, Saudi Arabia, Singapore, South Korea, the United Arab Emirates, the United States, and Vietnam. The
World Health Organization (WHO) authorized it for emergency use. 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
Food and Drug Administration (FDA). Pfizer applied for an EUA on 20 November 2020, and the FDA approved the application three weeks later on 11 December 2020. The US
Centers for Disease Control and Prevention (CDC)
Advisory Committee on Immunization Practices (ACIP) approved recommendations for vaccination of those aged sixteen years or older. Following the EUA issuance, BioNTech and Pfizer continued the PhaseIII clinical trial to finalize safety and efficacy data, leading to application for licensure (approval) of the vaccine in the United States. On 10 May 2021, the US FDA also authorized the vaccine for people aged 12 to 15 under an expanded EUA. In October 2021, the EUA was expanded to include children aged 5 through 11 years of age. In June 2022, the EUA was expanded to include children aged six months through four years of age. In February 2021, the South African Health Products Regulatory Authority (SAHPRA) in
South Africa issued Section 21, Emergency Use Approval for the vaccine. In May 2021,
Health Canada authorized the vaccine for people aged 12 to 15. On 18 May 2021, Singapore's
Health Sciences Authority authorized the vaccine for people aged 12 to 15. The
European Medicines Agency (EMA) followed suit on 28 May 2021. In June 2021, the UK
Medicines and Healthcare products Regulatory Agency (MHRA) came to a similar decision and approved the use of the vaccine for people twelve years of age and older. This is the first authorization under a standard procedure. In 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 COVID19 vaccine under the brand name Comirnaty. The recommendation was accepted by the
European Commission the same day. In February 2021, the
Brazilian Health Regulatory Agency approved the Pfizer–BioNTech COVID19 vaccine under its standard marketing authorization procedure. In June 2021, the approval was extended to those aged twelve or over. Pfizer's negotiation process with Brazil (and other Latin American countries) was described as "bullying". The contract prohibits the state of Brazil from publicly discussing the existence or the terms of their agreement with Pfizer–BioNTech without the former's written consent. Brazil was also restricted from donating or receiving donations of vaccines. In July 2021, the U.S.
Food and Drug Administration (FDA) granted
priority review designation for the biologics license application (BLA) for the Pfizer–BioNTech COVID-19 vaccine with a goal date for the decision in January 2022. On 23 August 2021, the FDA approved the vaccine for use for those aged sixteen years and older. In July 2022, the FDA approved the vaccine for use for those aged twelve years and older. The recommendation covers all existing and upcoming adapted Comirnaty vaccines, including the adapted Comirnaty Original/Omicron BA.1 (tozinameran/riltozinameran) and Comirnaty Original/Omicron BA.4/5 (tozinameran/famtozinameran). The country expanded the availability to all Israelis over the age of 12, after five months since their second shot. On 29 August 2021, Israel's coronavirus czar announced that Israelis who had not received a booster shot within six months of their second dose would lose access to the country's
green pass vaccine passport. Studies performed in Israel found that a third dose reduced the incidence of serious illness. In August 2021, the
United States Department of Health and Human Services (HHS) announced a plan to offer a
booster dose eight months after the second dose, citing evidence of reduced protection against mild and moderate disease and the possibility of reduced protection against severe disease, hospitalization, and death. The US
Food and Drug Administration (FDA) and the
Centers for Disease Control and Prevention (CDC) authorized the use of an additional mRNA vaccine dose for immunocompromised individuals at that time. Scientists and the WHO noted in August 2021, the lack of evidence on the need for a booster dose for healthy people and that the vaccine remains effective against severe disease months after administration. In a statement, the WHO and
Strategic Advisory Group of Experts (SAGE) said that, while protection against infection may be diminished, protection against severe disease will likely be retained due to
cell-mediated immunity. Research into optimal timing for boosters is ongoing, and a booster too early may lead to less robust protection. In September 2021, the FDA and CDC authorizations were extended to provide a third shot for other specific groups. In October 2021, the
European Medicines Agency (EMA) stated that a booster shot of the vaccine could be given to healthy people, aged 18 years and older, at least six months after their second dose. The final approval to provide booster shots in the European Union will be decided by each national government. In October 2021, the FDA and the CDC authorized the use of either homologous or heterologous vaccine booster doses. In October 2021, the Australian
Therapeutic Goods Administration (TGA) provisionally approved a booster dose of Comirnaty for people 18 years of age and older. In January 2022, the FDA expanded the emergency use authorization to provide for the use of a vaccine booster dose to those aged 12 through 15 years of age, and it shortened the waiting period after primary vaccination to five months from six months. In May 2022, the FDA expanded the emergency use authorization to provide for the use of a vaccine booster dose to those aged 5 through 11 years of age. In August 2022, the FDA revoked the emergency use authorization for the monovalent vaccine booster for people aged twelve years of age and older and replaced it with an emergency use authorization for the bivalent vaccine booster dose for the same age group. The bivalent vaccine authorized in the United States is different from the one that was authorized for use in the United Kingdom While the Omicron BA.1 vaccine has been tested in a clinical study, the Omicron BA.4/BA.5 vaccine was only tested in pre-clinical studies. According to the published presentation, the neutralization responses of Omicron BA.4/BA.5 monovalent, Omicron BA.1 mononvalent, Omicron BA.4/BA.5 bivalent and the original BNT162b2 vaccine have been explored in a study with
BALB/c-mice. In October 2022, the FDA amended the authorization for the bivalent booster to cover people aged five years of age and older. In December 2022, the FDA amended the authorization for the bivalent booster to be used as the third dose in people aged six months through four years of age.
XBB.1.5 monovalent vaccine In September 2023, the FDA approved an updated monovalent (single) component Omicron variant XBB.1.5 version of the vaccine (Comirnaty 20232024 formula) as a single dose for individuals aged twelve years of age and older; The approvals and emergency authorizations for the bivalent versions of the vaccine were revoked. Health Canada approved the Pfizer-BioNTech Comirnaty Omicron XBB.1.5 subvariant, monovalent COVID19 vaccine in September 2023.
JN.1 monovalent vaccine Comirnaty JN.1 contains bretovameran, an mRNA molecule with instructions for producing a protein from the Omicron JN.1 subvariant of SARS-CoV-2. It is under evaluation in Australia. and Southern Hemisphere 2026 autumn. == Society and culture ==