The Food and Drug Administration approved updated booster shots for COVID-19 on Monday, a major step toward launching a fall immunization campaign against the virus that is now viewed as a perennial but manageable threat.
Regulators said the shots from Pfizer and Moderna are tailored to combat the XBB.1.5 variant that began circulating earlier this year and will replace the “bivalent” shots introduced last fall.
The updated shots will be manufactured similarly to previous versions and the approval is based on immune response data in lab conditions, according to the FDA.
“The public can be assured that these updated vaccines have met the agency’s rigorous scientific standards for safety, effectiveness, and manufacturing quality. We very much encourage those who are eligible to consider getting vaccinated,” said Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research.
The FDA fully approved the updated vaccines for persons 12 years and older and authorized them for emergency use in persons aged 6 months to 11 years.
Persons aged 5 years and older can get a single dose of an updated vaccine at least two months after the last dose of any COVID-19 vaccine, regardless of their previous vaccination.
Children younger than 5 may be eligible for multiple doses of the updated shots, depending on when — and if — they received a primary series.
Advisers to the Centers for Disease Control and Prevention are scheduled to meet Tuesday to discuss the updated boosters and recommendations for who should get them.
Some health professionals think recommendations should be tailored toward at-risk populations instead of a blanket recommendation to get boosted each year.
The Biden administration is expected to promote the booster shots alongside flu shots and a brand-new vaccine against RSV, a common virus, for persons 60 and older.
Health officials are starting to characterize the COVID-19 shots as an annual rite like the flu shot, rather than an add-on to previous shots.
The new campaign will begin as COVID-19 cases rise across America, sparking another debate about mask rules, though hospitalizations remain low and many people are moving beyond fear of the virus.
Nearly seven in 10 Americans received a two-dose primary series of a COVID-19 vaccine. But additional shots have been a tougher sell, with only 17% of the population receiving the booster unveiled last fall.
Over 43% of seniors got an updated booster, however, and others likely have acquired some level of immunity from previous infections.
The vaccines were developed in record time during the first year of the pandemic. The main options from Pfizer and Moderna deploy messenger RNA, which teaches the body how to recognize the virus and mount an immune response. The shots haven’t been able to block infection and transmission outright, and are mainly viewed as tools to limit serious disease.
The coronavirus continues to mutate, so drugmakers are trying to fine-tune the shots to match circulating strains as best as possible, akin to updated flu shots.
The federal government is no longer purchasing the COVID-19 shots on behalf of Americans.
Rather, the shots will be paid for by insurers or government programs for the uninsured through local clinics and pharmacies.
For more information, visit The Washington Times COVID-19 resource page.
• Tom Howell Jr. can be reached at thowell@washingtontimes.com.
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