In response to Pfizer, the ultimate information evaluation reveals the Covid vaccine is 95% efficient. It needs to be submitted to the FDA in a couple of days
Pfizer and BioNTech announced on Wednesday that a final data analysis found their coronavirus vaccine was 95% effective against Covid-19 and appeared to ward off serious illness.
The vaccine, called BNT162b2, becomes highly effective against the virus 28 days after the first dose, and its effectiveness has been consistent across all ages, races, and ethnic groups, according to the drug makers. In addition, older people who are at high risk of serious illness from Covid-19 saw vaccine effectiveness greater than 94%, the companies said.
"The final analysis underscores the results of the positive interim efficacy analysis announced on November 9," said Ugur Sahin, CEO of BioNTech, in a statement. "The data show that our vaccine … can induce a high rate of protection against COVID-19 just 29 days after the first dose. In addition, it has been observed that the vaccine is well tolerated in all age groups with mostly mild age groups to alleviate side effects, which may be partly due to the relatively low dose. "
The vaccine also appeared to prevent serious illness in volunteers. Nine of the ten severe cases of Covid were in the phase 3 study in the placebo group. They also saw no "serious" safety concerns, as most of the adverse events resolved shortly after vaccination.
Pfizer shares rose 3% in premarket trading, while BioNTech's shares rose 6.2%.
The final analysis rated 170 confirmed Covid infections among the more than 43,000 participants in the late-stage study. The companies said that 162 cases of Covid were observed in the placebo group, while eight cases were observed in the group that received the two-dose vaccine. This resulted in an estimated vaccine effectiveness of 95%.
The news comes more than a week after companies announced their vaccine was more than 90% effective and two days after Moderna said preliminary third-phase data showed the vaccine was 94.5% . Both vaccines use messenger RNA or mRNA technology. It's a new approach to vaccines that uses genetic material to trigger an immune response.
A safe and effective vaccine is viewed by investors and policymakers as a solution to getting the global economy back on track after the pandemic wreaked havoc in almost every country. According to data from Johns Hopkins University, the virus continues to spread rapidly, with more than 55.6 million cases worldwide and at least 1.33 million deaths on Wednesday.
Vials with the label "COVID-19 / Coronavirus Vaccine / Injection Only" and a medical syringe can be seen in front of a displayed Pfizer logo in this image on October 31, 2020.
Dado Ruvic | Reuters
The initial results from Pfizer and BioNTech on November 9th were based on the first preliminary efficacy analysis conducted by an external and independent data monitoring committee from the Phase 3 clinical trial. The independent group of experts monitors clinical studies in the USA to ensure the safety of the participants.
Medical experts note that it remains unclear how long the vaccines provide immunity and whether or how often people need regular booster vaccinations.
"These vaccines will be approved and then launched with a few months' worth of data. They won't do a two-year study to see if they'll be effective for two years if more than 200,000 people die that year." Paul Offit, director of the Vaccine Education Center at Philadelphia Children's Hospital, in a recent interview.
Pfizer plans to file an application for emergency approval with the Food and Drug Administration "within days". Albert Bourla, CEO of Pfizer, told the New York Times Dealbook conference Tuesday that the company had collected enough safety data to submit the vaccine for review.
The companies reiterated that they expect to produce up to 50 million cans this year and up to 1.3 billion cans by 2021. They also said they were "confident" of distributing the vaccine, which requires a storage temperature of minus 94 degrees Fahrenheit. In comparison, Moderna's vaccine can be stored at minus 4 degrees Fahrenheit for up to six months.