WASHINGTON (AP) — U.S. regulators said Friday they are no longer considering authorizing a second COVID-19 booster for all adults under 50 this summer, instead focusing on revamped vaccines for the fall that will target new viral subvariants.
Pfizer and Moderna expect updated versions of their vaccines to be available as early as September, the Food and Drug Administration said in a statement. This would pave the way for a fall recall campaign to bolster protection against the latest omicron releases.
The announcement means the United States will not pursue a summer round of boosters using the current vaccines for adults under 50, as some Biden administration officials and outside experts have previously suggested. They had argued that another round of firing now could help prevent the rise in cases and hospitalizations caused by the highly transmissible omicron strains.
Currently, all Americans ages 5 and older are eligible for a booster shot five months after their first primary series. The fourth doses of the Pfizer or Moderna injections – a second booster – are recommended for Americans 50 and older and for young people with serious health conditions that make them more vulnerable to COVID-19.
The FDA has urged eligible adults who haven’t been boosted to get their extra shot now: “You can still take advantage of existing booster options and allow time to receive an updated booster in the fall,” said the agency in a press release.
The White House also stressed that getting a fourth dose now will have no impact on anyone’s ability to get targeted omicron injections once they become available – although the time that has passed since their last dose will play a role in how quickly they qualify.
Two sub-variants of omicronBA.4 and BA.5, are even more contagious than their predecessors and have pushed new daily cases above 125,000 and hospitalizations to 6,300. These are the highest levels since February, although deaths remained low at around 360 per day, thanks to widespread immunity and improved treatments for the virus.
The subvariants are offshoots of the strain responsible for nearly all of the virus spread in the United States this year.
All COVID-19 vaccines given in the United States so far have been based on the original version of the virus that began spreading across the country in early 2020.
In June, the FDA told vaccine makers that any fall recall should combine protection against omicron BA.4 and BA.5 and the original strain of coronavirus. Both manufacturers have ramped up production and data collection to have these so-called bivalent vaccines ready for the fall.
The FDA and the Centers for Disease Control and Prevention are expected to approve the revamped plans before they go live.
The United States has a contract to buy 105 million doses of Pfizer’s combined injections once they are ready, and 66 million of Moderna’s version. But how soon large quantities would become available is unclear. The government contracts include options to buy 300 million doses each, but reaching that total will require more congressional funding, the Biden administration said.
When it comes to timing, getting a booster too soon after the previous dose means losing all of its benefits – something decision makers will need to consider when rolling out revamped plans.
The White House has been frustrated at times with the pace of decision-making at the FDA and CDC, including last summer when regulators took weeks to decide whether to allow the first booster dose for American adults. . Privately, West Wing officials believe the delay cost lives, preventing optimal protection amid delta and omicron surges, but also fueled doubts about the effectiveness of vaccines and boosters that had a impact on their adoption.
In recent weeks, some of those frustrations have resurfaced, as regulators have considered recommending a fourth vaccine for all adults, not just those most at risk of contracting the virus. Some in the White House believe the extra dose would have helped the BA.5 subvariant spread somewhat quickly, and would also have boosted the confidence of anyone worried that its protection had diminished.
Still, officials across government have acknowledged the risks of vaccine fatigue among Americans, including tens of millions of people who still haven’t received their first booster. Government figures show that less than half of those eligible for a booster have received this third vaccine.
Associated Press writer Zeke Miller contributed to this story from Washington.
The Associated Press Health and Science Department is supported by the Howard Hughes Medical Institute Department of Science Education. The AP is solely responsible for all content.
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