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Pfizer and BioNTech have initiated a Phase 1/2/3 trial to evaluate a third dose of their COVID-19 vaccine, BNT162b2, aimed at studying safety and immunogenicity against evolving SARS-CoV-2 variants. Participants who received the initial two doses will be offered a booster dose 6 to 12 months later. They are also in discussions with regulatory authorities for a variant-specific mRNA vaccine, potentially targeting the B.1.351 lineage. The companies seek to ensure robust immunity and prepare for possible future vaccine adaptations, with ongoing assessments expected over two years.

Pfizer (NYSE: PFE) and BioNTech (Nasdaq: BNTX) are evaluating a third dose of their COVID-19 vaccine, BNT162b2, to assess safety and immunity against circulating and emerging SARS-CoV-2 variants. This study will involve participants from a previous Phase 1 trial, who will receive the booster 6 to 12 months post-initial vaccination. Additionally, the companies are in talks with the FDA and EMA for a clinical study on a variant-specific vaccine. The goal is to ensure preparedness against future variants while maintaining current vaccine effectiveness.

BioNTech (BNTX) and Pfizer have submitted data to the FDA to update the Emergency Use Authorization for their COVID-19 vaccine. The proposed change would allow the vaccine to be stored at -25°C to -15°C for up to two weeks, providing better logistical flexibility for pharmacies and vaccination centers. This submission includes stability data from the last nine months of development. The current storage requirement necessitates ultra-cold temperatures between -80ºC and -60ºC. If approved, the updated storage guidelines would enhance accessibility for vaccine distribution.

Pfizer and BioNTech have initiated a global Phase 2/3 trial for their COVID-19 vaccine (BNT162b2) involving about 4,000 healthy pregnant women in several countries, including the U.S. and U.K. The trial aims to assess the vaccine's safety and immunogenicity in this vulnerable group. Participants will be unblinded post-delivery, allowing those who received a placebo to be vaccinated. The trial follows prior studies indicating no reproductive toxicity in animals. This initiative marks a step towards ensuring vaccine safety for crucial populations.

On February 17, 2021, Pfizer and BioNTech released findings from an in vitro study confirming the Pfizer-BioNTech COVID-19 vaccine (BNT162b2) neutralizes the South African variant of SARS-CoV-2. Despite reduced neutralization against the variant's mutations, all sera tested effectively neutralized the variant. No evidence suggests that the variant escapes protection from the vaccine in vaccinated individuals. The companies are evaluating other variants and preparing for a potential updated mRNA vaccine. The vaccine is under Emergency Use Authorization in the U.S.

Pfizer and BioNTech have secured a new agreement with the European Commission to deliver an additional 200 million doses of the COMIRNATY vaccine, bringing the total supply to 500 million doses by the end of 2021. The agreement allows for an option of 100 million more doses. With this arrangement, at least 250 million Europeans could be vaccinated. Both companies are ramping up manufacturing capacity to meet global demand, aiming for around two billion doses by the end of 2021.

The U.S. government has exercised its option to purchase an additional 100 million doses of the Pfizer-BioNTech COVID-19 vaccine, bringing the total to 300 million. The government will pay $1.95 billion for these doses, aimed at vaccinating 150 million people. Pfizer and BioNTech are committed to increasing vaccine supply to combat COVID-19. The vaccine has been authorized for emergency use in individuals aged 16 and older. Manufacturing primarily occurs at Pfizer's Kalamazoo facility, utilizing BioNTech's proprietary mRNA technology.

BioNTech commenced mRNA production for the COVID-19 vaccine at its Marburg facility in Germany, aiming for an annual capacity of up to 750 million doses once fully operational. The initial batch can produce around eight million doses, with the first vaccines expected to be distributed in early April 2021. The facility has Good Manufacturing Practice (GMP) certification, ensuring high-quality standards. BioNTech plans to produce 250 million doses in the first half of 2021 and is undergoing a validation process with the European Medicines Agency (EMA) to confirm manufacturing quality.

Pfizer and BioNTech announced significant preclinical findings for their mRNA vaccine candidates, BNT162b1 and BNT162b2, targeting COVID-19. Results demonstrated that vaccinated rhesus macaques produced neutralizing antibodies up to 18.2 times higher than convalescent human serum. The vaccines also protected macaques from SARS-CoV-2 challenge without enhancing disease. These outcomes prompted the initiation of the pivotal Phase 3 trial for BNT162b2, which is currently authorized for emergency use in individuals aged 16 and older in the U.S.