Pfizer and BioNTech reported on Wednesday that, after a final analysis of their phase 3 trial, the Covid-19 vaccine they are developing is 95% effective and does not cause serious safety concerns.
The company has analyzed 170 cases of coronavirus infection among volunteers who participated in the trial, noting that 162 infections occurred in people who received placebo or plain saline injections, while eight cases were in participants who received the actual vaccine, which which shows that it is 95 percent effective, up from more than 90% that they announced last week.
“Efficacy was consistent across age, race, and ethnicity demographics. The observed efficacy in adults over 65 was over 94%, “said Pfizer and its German partner BioNTech in a joint statement published on CNN.
In addition, the companies have ensured that they have sufficient safety data on their coronavirus vaccine and that they are already preparing the authorization request to the American Drug Agency (FDA, for its acronym in English).
Specifically, as reported, 10 severe cases of Covid-19 were observed in the trial, nine of which occurred in the placebo group and one in the group vaccinated with BNT162b2, the experimental name of the vaccine. “To date, the Study Data Monitoring Committee has not reported any serious vaccine-related safety problems,” the companies said, commenting that the only relatively adverse event after the first or second dose was fatigue. .
“The rapid protection this vaccine provides, combined with its tolerability profile across all age groups studied so far, should help make this vaccine an important tool in addressing the current pandemic,” said the CEO and co-founder of BioNTech, Ugur Sahin.
The phase 3 clinical trial of the vaccine began on July 27. Pfizer said that of 43,661 volunteers enrolled, 41,135 have received a second dose of the vaccine or placebo. The FDA said volunteers needed at least two months of follow-up safety after receiving their second injections.
For this reason, experts have warned that it is not expected to have this vaccine before December, although according to current projections, companies expect to produce up to 50 million doses of vaccines worldwide in 2020 and up to 1.3 billion doses in 2021 .
Additionally, the 150 clinical trial sites conducted in the United States, Germany, Turkey, South Africa, Brazil, and Argentina will continue to collect information on efficacy and safety for two more years.
Pfizer has three US vaccine manufacturing plants in St. Louis, Kalamazoo, Michigan and Andover, Massachusetts, plus one in the Belgian town of Puurs, though BioNTech’s German sites will also be leveraged for global supply. “Pfizer relies on its vast experience, knowledge and existing cold chain infrastructure to distribute the vaccine worldwide,” they have asserted from the company.