Ongoing trial shows Pfizer Covid-19 vaccine remains highly effective after six months

(CNN)The ongoing Phase 3 clinical test of Pfizer/BioNTech’s coronavirus vaccine confirms its protection lasts a minimum of six months after the second dose, the businesses said Thursday.

The question of how long vaccine protection lasts can only be answered once enough time has passed, and while six months of protection may be a modest target, it’s longer than previously known. The study is constant and future updates may reveal more about how long and the way strong this protection is.
The vaccine remains quite 91% effective against disease with any symptoms for 6 months, the businesses said. And it seemed to be fully effective against the worrying B.1.351 variant of the virus, which is that the dominant strain circulating in South Africa and which researchers feared had evolved to evade the protection of vaccines, the businesses said.
“The vaccine was 100% effective against severe disease as defined by the U.S. Centers for Disease Control and Prevention (CDC), and 95.3% effective against severe COVID-19 as defined by the U.S. Food and Drug Administration (FDA),” Pfizer and BioNTech said during a joint statement.
Pfizer/BioNTech says its Covid-19 vaccine is 100% effective and well tolerated in adolescents
Pfizer/BioNTech says its Covid-19 vaccine is 100% effective and well tolerated in adolescents
On Wednesday, the businesses said a little trial of volunteers aged12 to fifteen showed 100% efficacy therein age bracket .
“These data confirm the favorable efficacy and safety profile of our vaccine and position us to submit a Biologics License Application to the U.S. FDA,” Albert Bourla, Pfizer’s chairman and chief military officer , said during a statement. A BLA is an application for full approval. The vaccine currently has emergency use authorization, EUA, which falls in need of full approval.
“The high vaccine efficacy observed through up to 6 months following a second dose and against the variant prevalent in South Africa provides further confidence in our vaccine’s overall effectiveness.”
The company has been studying the vaccine in additional than 46,000 volunteers and has noted 927 cases of confirmed Covid-19.
“From the 927 confirmed symptomatic cases of COVID-19 within the trial, 850 cases of COVID-19 were within the placebo group and 77 cases were within the BNT162b2 group, like vaccine efficacy of 91.3%,” it said.
“Thirty-two cases of severe disease, as defined by the CDC, were observed within the placebo group versus none within the BNT162b2 vaccinated group, indicating that the vaccine was 100% efficacious during this analysis against severe disease by the CDC definition. Twenty-one cases, as defined by the FDA, were observed within the placebo group versus one case within the BNT162b2 vaccinated group, indicating 95.3% efficacy by the FDA definition.”
Whatever happened to the coronavirus vaccine tiers?
Whatever happened to the coronavirus vaccine tiers?
These definitions matter. The FDA’s definition of severe disease included a raised rate of respiration indicating respiratory distress; raised pulse , an oxygen saturation level of 93% or lower; respiratory failure severe enough to wish additional oxygen or ventilation; a vital sign drop indicating shock; significant kidney, liver or neurological dysfunction, admission to an medical care unit or death.
CDC’s definition includes a blood oxygen level of 94% or lower and an x-ray finding of lung infiltrates — a sign of pneumonia — of greater than 50%
The most common adverse events were pain at the injection site, fatigue and headache.
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“In South Africa , where the B.1.351 lineage is prevalent and 800 participants were enrolled, nine cases of COVID-19 were observed, beat the placebo group, indicating vaccine efficacy of 100%,” the corporate said.
“Vaccine safety has now been evaluated in additional than 44,000 participants aged 16 years and older with quite 12,000 vaccinated participants having a minimum of six months of follow-up after their second dose.”

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