Officials at the Food and Drug Administration have approved extending COVID-19 boosters to Americans who got the Moderna or Johnson & Johnson vaccine. Additionally, the agency also gave the thumbs up to allow anyone eligible for an extra dose to get a brand different from the one they initially received.
The Food and Drug Administration’s decisions mark a big step toward expanding the U.S. booster campaign, which began with extra doses of the Pfizer vaccine last month. But before more people roll up their sleeves, the Centers for Disease Control and Prevention will consult an expert panel Thursday before finalizing official recommendations for who should get boosters and when.The latest moves would expand by tens of millions the number of Americans eligible for boosters and formally allow “mixing and matching” of shots — making it simpler to get another dose, especially for people who had a side effect from one brand but still want the proven protection of vaccination.Specifically, the FDA authorized a third Moderna shot for seniors and others at high risk from COVID-19 because of their health problems, jobs or living conditions — six months after their last shot. One big change: Moderna’s booster will be half the dose that’s used for the first two shots, based on company data showing that was plenty to rev up immunity again.For J&J’s single-shot vaccine, the FDA said all U.S. recipients, no matter their age, could get a second dose at least two months following their initial vaccination.
The ruling will now go to the Centers for Disease Control and Prevention (CDC) and its vaccine advisory committee for formal review and policy development.
If the committee issues a recommendation, and CDC Director Dr. Rochelle Walensky signs off, additional shots for those vaccines could be distributed immediately to eligible people.The authorization would open up booster doses to the more than 15 million people who have been inoculated with J&J’s shots and the more than 69 million people who have been fully immunized with Moderna’s vaccine.Eligible Americans will also be able to “mix and match” vaccines. A highly anticipated National Institutes of Health study published last week showed all the combinations of boosters increased antibody levels, though Pfizer’s and Moderna’s boosters appeared to work best.
However, there are a few caveats to the vaccine-joy that the press is spreading. FDA officials indicate an increased risk of rare inflammatory heart conditions, myocarditis, and pericarditis, following vaccination with the Moderna vaccine, particularly following the second dose.
The risk of mRNA Covid booster shots causing heart inflammation in young adults continues to worry top scientists weighing whether to approve third doses for anyone over 12, Dr. Ofer Levy, a voting member of the Food and Drug Administration’s advisory panel, said Friday.Levy, the director of the Precision Vaccines Program at Boston Children’s Hospital, spoke just hours after the FDA’s Vaccines and Related Biological Products Advisory Committee unanimously recommended giving second shots to all recipients of Johnson & Johnson’s single-dose Covid vaccine over 18 years old.The panel previously recommended the FDA approve boosters from Moderna and Pfizer for all seniors and other high-risk groups. But some committee members have voiced concern about authorizing third mRNA doses for people 12 and up due to the risk of two rare heart inflammation conditions, myocarditis and pericarditis.“As we go into younger and younger age groups, they’re less and less at personal risk of severe Covid, and on the other hand, somewhat more at risk of this inflammatory heart condition with the mRNA vaccine,” Levy told CNBC’s “Closing Bell.” “So it’s a risk benefit analysis, and that’s why you’re seeing that deliberation.”
Meanwhile, the US is now experiencing cases of the “Delta Plus” variant.
A new sub-lineage of the highly contagious Delta variant that is spreading throughout the UK has been detected in the United States, health officials said Wednesday.AY.4.2 is being closely monitored in the UK after British health officials revealed that the new variant — reported to be 10 to 15 percent more transmissible that Delta — had been linked to a growing number of COVID-19 infections there.
Of course, officials are assuring everyone the vaccine booster will totally work on this variant. Color me skeptical.
Fourteen Israelis have been diagnosed with COVID-19 despite having been inoculated with a third COVID-19 vaccine dose, according to Health Ministry data reported by Channel 12 news on Sunday.According to the network, two of those infected after receiving the booster shot have been hospitalized.
Here’s hoping public health officials start focusing on safe, effective, and inexpensive treatments sooner rather than later.
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