‘Watershed’ Coronavirus Vaccine Looks to Be 90% Effective in Phase 3 Trial of 43,500 People, Reports Pfizer

The first results of clinical trials involving 43,538 volunteers were announced today that showed a solid 90% success rate in protecting people against coronavirus.

As part of Phase 3 testing launched in July by developers Pfizer and BioNTech, participants from diverse backgrounds in six countries:in the United States, Germany, Brazil, Argentina, South Africa and Turkey—received two injections 21 days apart.

The analysis compared the number of COVID-19 cases among volunteers who received the vaccine with a group of volunteers of roughly the same size who received a placebo injection. The investigators reported that there was no disease contraction in more than 90% of the vaccinated group, thus far, with immune protection achieved 28 days after the first dose of the 2-dose schedule.

The US Food and Drug Administration (FDA) established a minimum effectiveness bar for COVID-19 vaccines at 50% for drugs seeking approval. This is the first COVID-19 candidate vaccine to produce data that surpasses that mark.

Whats Next?

The data presented is only a preliminary look at how the new vaccine appears to be working. More data on safety and efficacy continues to be collected.

Relying on an independent Data Monitoring Committee to analyze the results, Pfizer and BioNTech say they are continue to accumulate safety data and estimate that a median of two months of such data after the final dose, the amount of safety data specified by the FDA in its guidance for a possible emergency use authorization, will be available by the third week of November.

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According to its current projections, Pfizer would be ready to manufacture up to 50 million doses of vaccines globally by the end of the year and “up to 1.3 billion doses in 2021.”

Dr. Anthony Fauci, director of the US National Institute of Allergy and Infectious Diseases, described the trial results as “extraordinary” in an interview with the Washington Post, and said that since the American firm Moderna uses similar technology in its candidate vaccine, “It gives you hope that we can even have two shots.”

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