The U.S. Food and Drug Administration amended its emergency-use authorization on Thursday to allow booster shots of the Pfizer and Moderna Covid-19 vaccines for those who are immunocompromised and at greater risk of severe aftereffects if infected with the virus. The decision comes as the delta variant has caused a resurgence in cases comparable to winter 2021’s peak months.
Pfizer revealed at the end of July, its vaccine drops to 83.7% efficacy over four months after the second dose. As part of its second quarter-year earnings, Moderna also released six-month durability data, showing the two shots remain highly effective after 180 days.
Both companies have suggested third shots to boost protection against the delta variant, though the Centers for Disease Control and Prevention have noted vaccines are effective at preventing hospitalization and even death against Covid-19 regardless of a booster.
Still, “breakthrough” cases — individuals that contract Covid, despite being vaccinated — are being reported. The CDC has noted of the 164-plus million people vaccinated, between January and April 2021, 10,262 breakthrough cases were reported from 46 states and territories. From May to Aug. 2, 7,525 people experienced breakthrough infections, as reported from 49 states and territories.
In North Carolina, according to the News & Observer, “the state health department reported 7,297 potential breakthrough cases” from January through July 22. Of that, 383 were hospitalized with 33 deaths.
There isn’t data offered on how many of those breakthrough cases affected immunocompromised individuals, which make up less than 3% of the population. CDC will meet Friday to review the FDA’s recent decision and assess more clinical recommendations for this group of people. The high-risk individuals consist of cancer patients or those who have had organ transplants, according to the FDA, and take medicines or have ailments that weaken their immune systems.
FDA acting commissioner Dr. Janet Woodcock said in a statement: “As we’ve previously stated, other individuals who are fully vaccinated are adequately protected and do not need an additional dose of COVID-19 vaccine at this time.”
Booster shots already have begun overseas in nations like Germany and Israel, not just for immunocompromised but for seniors and people working in healthcare facilities.
“The FDA is actively engaged in a science-based, rigorous process with our federal partners to consider whether an additional dose may be needed [for others] in the future,” Woodcock added.
It’s unclear when the boosters will be made available for immunocompromised people to receive.
The FDA is expected to officially authorize use of the Pfizer vaccine this fall, which has been approved for ages 12 and older. All vaccines are currently administered under the FDA’s emergency use authorization.
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