Pfizer vaccine 91.3% effective after six months, Phase III study shows
pharmafile | April 6, 2021 | News story | Manufacturing and Production | BioNTech, COVID-19, COVID-19 vaccine, Pfizer, Pfizer vaccine, pfizer-biontech vaccine
Pfizer and BioNTech’s follow-up study of their COVID-19 vaccine has confirmed the jab’s high efficacy after up to six months, with an effectiveness of 91.3% against the virus.
The vaccine was also found to be 100% effective in preventing severe disease as defined by the CDC, and 95.3% effective in preventing severe disease as defined by the FDA.
Crucially, it was found to be 100% effective in preventing COVID-19 cases in South Africa, where the B.1.351 variant that first emerged in the country is prevalent.
The analysis of 46,307 participants was measured between seven days and six months after receipt of a patient’s second dose.
The Phase III trial found 927 confirmed symptomatic cases of COVID-19, with 850 of these coming from the placebo group; just 77 cases of the virus came from those administered with the vaccine.
32 cases of severe disease, as defined by the CDC, were observed in the placebo group versus none in the vaccinated group. 21 severe cases, as defined by the FDA, were observed in the placebo group versus one in the vaccinated group.
The shot has now been evaluated in more than 12,000 vaccinated participants after at least a six-month follow-up following their second dose.
Albert Bourla, Chairman and CEO at Pfizer, said: “These data confirm the favourable efficacy and safety profile of our vaccine and position us to submit a Biologics License Application to the FDA.
“The high vaccine efficacy observed through up to six months following a second dose and against the variant prevalent in South Africa provides further confidence in our vaccine’s overall effectiveness.”
Ugur Sahin, CEO and Co-founder of BioNTech, added: “It is an important step to further confirm the strong efficacy and good safety data we have seen so far, especially in a longer-term follow-up.
“These data also provide the first clinical results that a vaccine can effectively protect against currently circulating variants, a critical factor to reach herd immunity and end this pandemic for the global population.”
Jack Goddard
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