New Delhi, November 11: In a much needed breakthrough, the coronavirus vaccine by Pfizer Inc and its German partner BioNTech SE is touted to be 90 percent effective against the COVID-19 infection. Lauding the company's efforts, Pfizer Chairman and CEO Albert Bourla said it was great news for science and humanity as the first set of results from their Phase 3 COVID-19 vaccine trial provides the initial evidence of our vaccine's ability to prevent COVID-19. The news of an effective vaccine for coronavirus comes amid the possibility of a second wave of the deadly infection in several countries. Pfizer Says COVID-19 Vaccine 90% Effective in Phase 3 Trial, Likely to File for Emergency Use by November-End.
Talking about the development of the COVID-19 vaccine, Bourla said the Pfizer is reaching this critical milestone in their vaccine development program at a time when the world needs it most with infection rates setting new records, hospitals nearing over-capacity and economies struggling to reopen. COVID-19 Vaccine Update: US Plans to Start Vaccinating Americans in December 2020 if Pfizer Submits Positive Initial Data From Vaccine Trial to Health Regulators at the Earliest.
Phase 3 COVID-19 Vaccine Trial by Pfizer & BioNTech SE
The Phase 3 clinical trial of BNT162b2 began on July 27 and has enrolled 43,538 participants to date. Of the total participants, 38,955 have received a second dose of the vaccine candidate as of November 8, 2020, the statement said. The trial is continuing to enroll and is expected to continue through the final analysis when a total of 164 confirmed COVID-19 cases have accrued.
The study also will evaluate the potential for the vaccine candidate to provide protection against COVID-19 in those who have had prior exposure to SARS-CoV-2, as well as vaccine prevention against severe COVID-19 disease, it added.
Pfizer Effectiveness
With an aim to end the global health crisis, Pfizer has moved a step closer to providing people around the world with a much-needed COVID-19 vaccine. On Monday, Pfizer Inc and BioNTech SE said their vaccine candidate was found to be more than 90 per cent effective in preventing COVID-19. The shots made by Pfizer and its German partner BioNTech are among 10 possible vaccine candidates in late-stage testing around the world -- four of them so far in huge studies in the US.
Pfizer Statement
After discussion with the Food and Drug Administration (FDA), the companies recently elected to drop the 32-case interim analysis and conduct the first interim analysis at a minimum of 62 cases, the statement by the company said. However, Pfizer Inc did not provide any more details about those cases, and cautioned the initial protection rate might change by the time the study ends.
Reports inform that the announcement does not mean a vaccine is imminent. This interim analysis, from an independent data monitoring board, looked at 94 infections recorded so far in a study that has enrolled nearly 44,000 people in the US and five other countries, news agency AP reported.
BioNTech Statement
BioNTech co-founder and CEO Ugur Sahin said that the first interim analysis of our global Phase 3 study provides evidence that a vaccine may effectively prevent COVID-19. This is a victory for innovation, science and a global collaborative effort.
When is the Vaccine Expected to Be Launched
The Pfizer-BioNTech shot is one among 10 vaccine candidate. According to the current projections, the companies expect to produce globally up to 50 million vaccine doses in 2020 and up to 1.3 billion doses in 2021. The companies also plan to submit data from the full Phase 3 trial for scientific peer-review publication, the company statement read.
Dr. Anthony Fauci, who is the US government's top-infectious disease expert, said that the results of the Pfizer vaccine's 90 per cent effectiveness are "just extraordinary". According to a report by Reuters, Health Secretary Alex Azar on Tuesday said that of Pfizer Inc submits the positive initial data from its COVID-19 vaccine trial to health regulators at the earliest, the US government plans to begin vaccinating Americans in December. The report added that the US drugmaker said it expects to have safety data as soon as next week that it needs to apply for emergency use authorization (EUA) with the U.S. Food and Drug Administration.
Reports inform that the European Commission will sign a deal to secure up to 300 million doses of the experimental coronavirus vaccine developed by BioNTech and Pfizer. Ursula von der Leyen, the president of the EU's executive arm, said the commission will authorize the deal on Wednesday after “working tirelessly to secure doses of potential vaccines” in recent months.
Talking about the availability of Pfizer coronavirus vaccine in India, a CMC Vellore professor, who is also known for her work on vaccines said that it is expected to be expensive and difficult to deliver in India. In an interview with Scroll.in, medical scientist Dr Gagandeep Kang said Pfizer's vaccine is an mRNA vaccine which are going to be very expensive.
(The above story first appeared on LatestLY on Nov 11, 2020 12:17 PM IST. For more news and updates on politics, world, sports, entertainment and lifestyle, log on to our website latestly.com).