Saturday , July 24 2021

Pfizer says vaccine protection against mumps lasts at least six months, protects against variations

The ongoing phase 3 clinical trial of Pfizer / BioNTech Coronavirus vaccine confirms that protection lasts at least six months after the second dose, the companies said on Thursday.

It’s the first look at how long protection for a coronavirus vaccine lasts, and while six months is a modest goal, it’s more than 90 days of protection that was the best estimate offered to date.

The vaccine remains more than 91% effective against the disease with symptoms for six months, the companies said. And it appeared to be fully effective against the alarming variant of the B.1.351 virus, which is the dominant strain in South Africa and which researchers fear evolved to avoid vaccine protection, the companies said.

The vaccine was 100% effective against severe disease as defined by the US Centers for Disease Control and Prevention (CDC), and 95.3% effective against severe COVID-19 as prescribed by the Food and Drug Administration US (FDA), “Pfizer and BioNTech said in a joint statement.

On Wednesday, companies said a small trial of volunteers aged 12 to 15 showed 100% effectiveness in this age group.

“These data confirm the favorable efficacy and safety profile of our vaccine and prompt us to apply for a biology license to the US FDA,” said Albert Bourla, Pfizer President and CEO, in a statement. BLA is an application for full approval. The vaccine currently has an emergency authorization, EUA, which is not fully approved.

“The high efficacy of the vaccine observed up to six months after a second dose and against the variant prevailing in South Africa provides further confidence in the overall efficacy of our vaccine.”

The company is studying the vaccine in more than 46,000 volunteers and has recorded 927 cases of confirmed Covid-19.

“Of the 927 confirmed symptomatic COVID-19 cases in the trial, 850 cases of COVID-19 were in the placebo group and 77 cases in the BNT162b2 group, which corresponded to a 91.3% vaccine efficacy,” he said.

Thirty-two cases of severe disease, as defined by the CDC, were observed in the placebo group compared to none in the BNT162b2 vaccinated group, indicating that the vaccine was 100% effective in this assay against severe disease by the CDC definition. one case, as defined by the FDA, was observed in the placebo group versus one case in the vaccinated BNT162b2 group, indicating 95.3% efficacy from the FDA definition. “

These definitions matter. The FDA definition of severe disease included an increased respiratory rate indicating respiratory distress. increased heart rate, oxygen saturation level 93% or lower. respiratory failure severe enough to require extra oxygen or ventilation. drop in blood pressure showing shock. significant renal, hepatic or neurological impairment, intensive care unit or death.

The CDC definition includes a blood oxygen level of 94% or less and an X-ray finding of the lung infiltrates – indication of pneumonia – greater than 50%

The most common side effects were injection pain, fatigue and headache.

“In South Africa, where the B.1.351 genealogy is widespread and involved 800 participants, nine cases of COVID-19 were observed, all in the placebo group, showing 100% vaccine efficacy,” the company said.

“Vaccine safety has now been evaluated in more than 44,000 participants aged 16 years and older, with more than 12,000 vaccinated participants having at least six months of follow-up after their second dose.”

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