The United States plans to start widely distributing COVID-19 booster shots of either Moderna (NASDAQ: MRNA) or Pfizer (NYSE: PFE)-BioNTech (NASDAQ: BNTX) vaccines next month as new data shows that vaccine protection diminishes over time, top U.S. health officials announced Wednesday.
Health officials have now found evidence that immunity begins to wane after the initial two doses of both vaccines developed by Moderna and Pfizer-BioNTech, especially with the nationwide prevalence of the highly effective Delta variant. Officials also found that overtime the vaccines' protection also reduces against mild and moderate disease.
"Based on our latest assessment, the current protection against severe disease, hospitalization, and death could diminish in the months ahead, especially among those who are at higher risk or were vaccinated during the earlier phases of the vaccination rollout," said a joint statement signed by Centers for Disease Control and Prevention (CDC) Director Dr. Rochelle Walensky, Food and Drug Administration (FDA) Commissioner Dr. Janet Woodcock, White House Chief Medical Advisor Dr. Anthony Fauci and other U.S. health officials released Wednesday.
Based on the new recommendation, the U.S. Department of Health and Human Services expects to begin offering booster shots to all eligible Americans stating the week of Sept. 20, starting eight months after their second dose of vaccine. The plan is still subject to CDC vaccine advisory recommendation and approval from the FDA.
"At that time, the individuals who were fully vaccinated earliest in the vaccination rollout, including many health care providers, nursing home residents, and other seniors, will likely be eligible for a booster," officials said. "We would also begin efforts to deliver booster shots directly to residents of long-term care facilities at that time, given the distribution of vaccines to this population early in the vaccine rollout and the continued increased risk that COVID-19 poses to them."
While officials expect that recipients of Johnson & Johnson's (NYSE: JNJ) single-dose vaccine will need booster shots in the future, more research is needed before officials make a formal recommendation.
"Our top priority remains staying ahead of the virus and protecting the American people from COVID-19 with safe, effective, and long-lasting vaccines especially in the context of a constantly changing virus and epidemiologic landscape," officials said.
"We also want to emphasize the ongoing urgency of vaccinating the unvaccinated in the U.S. and around the world. Nearly all the cases of severe disease, hospitalization, and death continue to occur among those not yet vaccinated at all," officials added. "We will continue to ramp up efforts to increase vaccinations here at home and to ensure people have accurate information about vaccines from trusted sources. We will also continue to expand our efforts to increase the supply of vaccines for other countries, building further on the more than 600 million doses we have already committed to donate globally."
The new U.S. booster recommendation comes soon after Pfizer and BioNTech announced they have submitted early stage clinical trial data to the FDA as part of their overall U.S. application seeking authorization of a vaccine booster for Americans aged 16 years or older.