Pfizer expects to submit EAU for booster shot as early as August
Vaccination immunity may wane and, a dose given six months after the second shot boosts antibodies against the Delta variant, Pfizer says.
Photo: Longhua Liao/Getty Images
Pfizer is having ongoing discussions with regulatory agencies for a booster dose of its COVID-19 vaccine, and is potentially submitting an emergency use authorization application for the additional vaccine as early as August.
A first batch of the Delta variant vaccine has been manufactured, Pfizer said in its second quarter earnings statement, with clinical studies projected to begin next month, subject to regulatory approvals.
Emerging data suggests vaccination immunity against infection and symptomatic disease may wane, Pfizer said. This is because initial data shows a booster given six months after the second dose of the vaccine strongly boosts the antibodies against the Delta strain.
Americans who have been fully vaccinated do not need a booster shot at this time, the Centers for Disease Control and Prevention and the Food and Drug Administration said in a joint statement on July 8.
WHY THIS MATTERS
The number of COVID-19 cases is again climbing due to the Delta variant.
President Joe Biden today is expected to announce that all civilian federal workers will need to be vaccinated against the coronavirus or face regular testing, social distancing, mask requirements and travel limits, according to Reuters.
Provider and payer organizations support the mandatory vaccination of healthcare workers.
Pfizer, Modern, and Johnson & Johnson have emergency use authorization for their vaccines. Pfizer said it expects potential full Biologics License Application for its original two-dose vaccine. It has been granted priority review for January 2022.
THE LARGER TREND
An estimated half of Americans are fully vaccinated, with hospitalization rates climbing. Most of the more severe cases are in patients who are unvaccinated.
The Delta variant is more than twice as transmissible as other strains of the virus, according to the Centers for Disease Control and Prevention.
From June 19 to July 23, COVID-19 cases increased approximately 300% nationally, followed by increases in hospitalizations and deaths, driven by the highly transmissible Delta variant, the CDC said.
Due to the rise in the number of cases, the CDC this week reversed earlier guidance and now recommends that vaccinated individuals wear masks indoors to help prevent the spread of COVID-19.
Twitter: @SusanJMorse
Email the writer: susan.morse@himssmedia.com
