On Tuesday, the U.S. Food and Drug Administration (FDA) authorized the second booster shot of the Pfizer-BioNTech and the Moderna COVID-19 vaccines for people aged 50 years and older and for people aged 12 years and older who have received organ transplants or who have compromised immune systems. The decision comes after ongoing research has confirmed the safety of the additional booster shot, as well as its protective benefits.
“Emerging evidence suggests that a second booster dose of an mRNA COVID-19 vaccine improves protection against severe COVID-19 and is not associated with new safety concerns,” the FDA said in a statement. The second booster can only be administered to individuals at least four months after they have received their first booster shot of any authorized COVID-19 vaccine.
“Current evidence suggests some waning of protection over time against serious outcomes from COVID-19 in older and immunocompromised individuals,” Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, said in the statement. “Based on an analysis of emerging data, a second booster dose of either the Pfizer-BioNTech or Moderna COVID-19 vaccine could help increase protection levels for these higher-risk individuals.”
The FDA’s latest decision was primarily shaped by safety surveillance data provided by the Ministry of Health of Israel. This data included the administration of around 700,000 second booster shots of the Pfizer vaccine. These were given at least four months after the first booster dose in adults aged 18 years and older, though the vast majority were aged 60 years and older. Their analysis revealed “no new safety concerns.”
The ongoing surge in BA.2, the highly contagious omicron subvariant, has also motivated the push for people to get boosted for a second time. “During the recent Omicron surge, those who were boosted were 21-times less likely to die from COVID-19 compared to those who were unvaccinated, and 7-times less likely to be hospitalized,” the Centers for Disease Control and Prevention (CDC) said in response to the announcement of additional boosters.
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The World Health Organization (WHO) confirmed last week that BA.2 has become the dominant COVID-19 variant globally. The organization’s recent epidemiological update stated that “the relative proportion of BA.2 has increased steadily since the end of 2021, with BA.2 becoming the dominant lineage by week seven of 2022.” As of March 26, BA.2 was estimated to make up nearly 55% of COVID-19 cases in the U.S., while BA.1 (the original omicron variant) made up about 40% of cases. BA.2 is considered to be around 30% more transmissible than BA.1, according to research estimates confirmed by the WHO.
The White House has confirmed it has enough vaccines available for the additional booster doses. “We do have sufficient current inventory of vaccines, both at states and pharmacies, in other access points around the country, and in our central inventory for fourth doses if they’re called for this spring for our most vulnerable, including seniors,” Jeffrey Zients, White House Coronavirus Response Coordinator, said in a press conference last week.
The FDA is still investigating whether the second booster will be authorized for use in additional age groups. “CDC, in collaboration with FDA and our public health partners, will continue to evaluate the need for additional booster doses for all Americans,” said CDC Director Rochelle P. Walensky, MD, MPH. According to the CDC, just 44% of fully vaccinated people in the U.S. have received their first booster shot. The agency continues to urge all eligible adults and children (aged five and older) to get fully vaccinated.
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Source: SELF
