Pfizer says the study shows that a booster dose after 6 to 12 months is likely to provide the best protection from COVID-19.

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A study showed that antibody titer 5-10 times higher than two doses.

July 9, 2021, 12:54 am

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Pfizer and BioNTech released preliminary data from a study of booster shots of the COVID-19 vaccine, saying that a third dose delivered about six months after the second shot showed that equivalent titers were five to 10 times higher than after two base doses.

The companies said they expect to publish “more specific data” soon and submit it to the Food and Drug Administration “in the coming weeks.”

Pfizer said factual evidence from Israel showed a decrease in efficacy about six months after people were fully vaccinated.

“While protection against severe disease remained high over the full six months, the observed decrease in efficacy against symptomatic disease over time and persistence of variants are key factors that lead us to believe that a booster dose would likely be necessary to maintain the highest levels of protection,” Pfizer said in a statement “.

The Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention issued a joint statement Thursday night pumping the brakes on the need for a booster dose thus far, and encouraging people to get vaccinated in general. Less than 50% of the US population is fully vaccinated at this time.

“Fully vaccinated Americans do not currently need a booster dose,” the agencies said in the statement. “The FDA, CDC, and NIH (National Institutes of Health) are involved in a rigorous science-based process to consider whether or not it is necessary to use a booster.”

In addition, the companies are working on materials with a plan to test building a new vaccine based on the delta variant — with plans to start clinical trials in August.

“While we believe that a third dose of BNT162b2 has the potential to maintain the highest levels of protective efficacy against all currently known variants including delta, we remain vigilant and develop an updated version of the Pfizer-COVID-19 vaccine that uses a novel construct based on the B.1.617 lineage. 2, which was first identified in India and is also known as the delta variable,” the companies said in a statement.

“The companies are already producing clinical trial materials and expect to begin clinical studies in August, subject to regulatory approvals,” added Pfizer and BioNTech.

A healthcare worker holds a vial of the Pfizer/BioNtech COVID-19 vaccine at Memorial Healthcare System in Miramar, Florida, on December 14, 2020.

Moderna, the manufacturer of the only approved mRNA vaccine in the United States, has made similar statements about the need for booster injections in the past.

“Boost shots will be needed because we believe the virus is not going to go away,” Moderna CEO Stéphane Bancel said during his first-quarter earnings call to investors in early May.

It will be up to the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention to determine if and when the booster injections will be permitted, recommended and available.

“It’s clear that pharmaceutical companies have an economic incentive, especially those with for-profit vaccines,” Dr. Dan Baruch, director of the Center for Virus and Vaccine Research at Beth Israel Deaconess Medical Center, told ABC News in late May. . “We want the decision to be made based solely on public health and [not] on economic incentives for companies.

Anne Flaherty, Arielle Mitropoulos, and Dr. Deepak Ramanathan and Sony Salzman of ABC News.

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