Coronavirus: EU could receive up to 300 million doses of Pfizer’s seemingly effective vaccine

Mamer told a press conference that this is the fourth contract that the EU commission is concluding with pharmaceutical companies to procure a coronavirus vaccine.

The agreement will initially allow all EU member states to purchase 200 million doses of vaccine, as well as the possibility to request an additional 100 million doses.

The vaccine, developed by the two companies, is the most promising coronavirus vaccine ever produced, so the European Commission is working to distribute it in Europe as soon as it becomes available, he added.

Shipments of the SARS-CoV-2 candidate vaccine BNT162b2 to the EU are expected to begin in late 2020, depending on the success of clinical trials and regulatory approval.

Vaccine doses for Europe will be manufactured at BioNTech sites in Germany and Pfizer sites in Belgium. If the BNT162b2 candidate vaccine is approved by the European Medicines Agency, EU member states wishing to receive the vaccine under this agreement will request the vaccine, Pfizer said in a statement.

On September 9, 2020, Pfizer and BioNTech announced the conclusion of exploratory discussions with the European Commission regarding the supply of the candidate vaccine BNT162b2 with the necessary permits. This delivery agreement is final. On November 9, 2020, Pfizer and BioNTech announced that an mRNA-based vaccine candidate for SARS-CoV-2, BNT162b2, had demonstrated efficacy in preventing COVID-19 infection in subjects who had no prior evidence of SARS- CoV-2. infection. The reporting was based on the first interim efficacy analysis of the third phase of clinical trials conducted on November 8, 2020 by an independent external Data Monitoring Committee (DMC). The Data Monitoring Committee examined 94 cases. At 7 days after the second dose of the vaccine, the distribution of cases between vaccinated recipients and those who received placebo indicates that the vaccine is more than 90% effective. This means that protection can be achieved with the two vaccination doses 28 days after vaccination.

Continuing the study may change the final percentage of vaccine efficacy, Pfizer said. The Data Monitoring Committee did not report any serious safety concerns and recommends that the investigation continue to collect the anticipated additional safety and efficacy data.

The BNT162 program is based on BioNTech’s proprietary mRNA technology supported by Pfizer’s global vaccine development and manufacturing capabilities. Two of the four study candidate vaccines for the aforementioned companies, BNT162b1 and BNT162b2, received Fast Track approval from the US Food and Drug Administration (FDA), US levels 1 and 2 ongoing. And Germany. based on preliminary data from phase I studies and animal immunogenicity studies. In preclinical and clinical trials, BNT162b1 and BNT162b2 were shown to be strong candidates based on safety and immune response evaluation. On July 27, Pfizer and BioNTech announced that after a comprehensive review of preclinical and clinical data from Phase 1 and Phase 2 clinical trials, and with the FDA’s Center for Biological Products Evaluation and Research (CBER) and In consultation with other global regulatory bodies, the two companies selected the candidate vaccine BNT162b2 for inclusion in phase 2 and phase 3 clinical trials. BNT162b2 encodes an optimized full-length SARS-CoV-2 peak glycoprotein (S) that it is a target for virus neutralizing antibodies.

The phase 3 clinical trial of BNT162b2 began on July 27, 2020. To date, 43,538 participants have enrolled in the study, 38,955 of whom received the second dose of the candidate vaccine on November 8, 2020. Approximately 42 % of global participants and 30% of American participants have diverse racial and ethnic origins. The study will continue to receive participants and is expected to continue until all 164 confirmed COVID-19 cases are pooled in the final analysis. The study will also evaluate how a vaccine candidate can protect against COVID-19 in those who have previously been exposed to SARS-CoV-2 infection and how it prevents severe COVID-19 infection. In addition to the primary efficacy endpoints (showing development of COVID-19 infection 7 days after the second dose of the vaccine), with approval from the US Food and Drug Administration (FDA ), the final analysis will include new secondary endpoints to assess efficacy in the cases studied 14 days after the second dose. The companies believe that the indication of secondary endpoints will help harmonize data from all COVID-19 vaccine trials and allow for comparison of new vaccines, exchange of experiences between clinical trials, and learning.

Assuming the success of the clinical trial, the availability of the necessary manufacturing and safety data, Pfizer and BioNTech currently predict that it would deliver up to 50 million doses of vaccine worldwide by 2020 and around 1.3 billion doses by the end of 2021.

Pfizer’s stock price fell 0.9 percent today.