Pfizer Says Final Analysis Shows Covid-19 Vaccine Is 95% Effective With No Safety Concerns
A final analysis of the Phase 3 trial of Pfizer’s Covid-19 vaccine shows that it’s 95% effective in preventing infections with no serious side effects, even in older adults. Of the participants that took part in the trial the company counted 170 cases of Covid-19; 162 of those infections were in people who were given the placebo vaccine, which was just plain saline, while eight of the infections were in those who got the actual vaccine, making the efficacy of Pfizer’s vaccine 95%.
Initially, Pfizer’s data showed that the vaccine was only 90% effective, which still would’ve been more than enough to be distributed and used among the world, however, after further analysis Pfizer and partner BioNTech claimed that “efficacy was consistent across age, race and ethnicity demographics. The observed efficacy in adults over 65 years of age was over 94%,” the two said in a joint statement.
Pfizer claims that it will be seeking emergency use authorization from the US Food and Drug Administration “within days” now that they have these final results. The data will also be submitted to other regulatory agencies around the world for manufacturing and distribution. Dr. Ugur Sahin, CEO and co-founder of BioNTech, recently spoke with the media about how hopeful his whole team has been in regard to this vaccine and all the advancements the science community is starting to see that will help finally bring this pandemic to an end.
“The rapid protection this vaccine provides — combined with its tolerability profile in all age groups studied so far — should help make this vaccine an important tool to address the current pandemic.”
The Phase 3 clinical trial for Pfizer’s vaccine began on July 27th. Of the 43,661 volunteers enrolled, 41,135 had received a second dose of either the vaccine or placebo. The FDA said that it wanted at least two months of safety tracking on said volunteers after they got their second dose. The companies also made it a point to hire as diverse of a group of volunteers as possible to ensure the vaccine won’t impact certain demographics differently.
“Approximately 42% of global participants and 30% of U.S. participants have racially and ethnically diverse backgrounds, and 41% of global and 45% of U.S. participants are 56-85 years of age,” Pfizer said, adding that the 150 clinical trial sites in the United States, Germany, Turkey, South Africa, Brazil and Argentina will continue to collect information about efficacy and safety for two more years.
“Based on 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.”
Pfizer has three US vaccine manufacturing sites located within Michigan and Massachusetts. Many states, however, have expressed their concern over the fragility of the Pfizer vaccine, which must be kept at a temperature of minus 75 degrees Celsius; far below the capacity of the average medical freezer located in pharmacies and doctors offices.
However, Pfizer is confident that their custom vaccine packaging will maintain the vaccine’s freshness and ensure it remains safe and effective by the time it’s injected into patients. “The companies have developed specially designed, temperature-controlled thermal shippers utilizing dry ice to maintain temperature conditions of -70°C. They can be used as temporary storage units for 15 days by refilling with dry ice. Each shipper contains a GPS-enabled thermal sensor to track the location and temperature of each vaccine shipment across their pre-set routes leveraging Pfizer’s broad distribution network.”
Between this vaccine and Moderna’s announcement that their vaccine is also testing at 95% efficacy, the world is beginning to regain some hope in terms of this pandemic coming to an end. For now, however, it is imperative that every individual doesn their part to continue to curb the spread by wearing a mask, staying home, and social distancing when prompted.
Eric Mastrota is a Contributing Editor at The National Digest based in New York. A graduate of SUNY New Paltz, he reports on world news, culture, and lifestyle. You can reach him at eric.mastrota@thenationaldigest.com.