The Riverside Press-Enterprise
Vaccine boosters for all near OK
WASHINGTON >> The Food and Drug Administration is aiming to authorize booster doses of Pfizer-biontech’s coronavirus vaccine for all adults as early as Thursday, a move that would expand the number of Americans eligible for additional shots by tens of millions, according to people familiar with the agency’s plans.
The Centers for Disease Control and Prevention’s independent committee of vaccine experts has scheduled a meeting for Friday to discuss data on the booster dose’s efficacy and safety. If both the FDA and the CDC sign off this week, they will have acted strikingly quickly — a little more than a week after Pfizer asked for authorization of boosters for everyone 18 and older.
Under that scenario, any adult who received a second dose of the vaccine at least six months earlier would be officially eligible to get a booster as soon as this weekend. The FDA is expected to rule without consulting its own expert panel, which has met frequently during the pandemic to review vaccine data and make a recommendation ahead of a regulatory decision.
Moderna is expected to soon submit its own request for the FDA to broaden eligibility for its booster. But for now, every adult could get the Pfizer booster, according to people familiar with the planning.
The broad booster authorization has been viewed as something of a fait accompli for weeks. Some state and local officials have begun rolling out similar policies ahead of FDA action — responding to persistent virus case counts and the eagerness of many Americans to seek additional protection ahead of holiday gatherings.
California encouraged local health providers to expand access last week, and Arkansas, Colorado and New Mexico have also moved to expand access. New York City health officials on Monday encouraged all adults who want boosters to seek them out.
Many Americans, regardless of where they live, have taken the matter into their own hands and sought out extra doses even if they do not officially qualify yet.
The FDA in September downsized Pfizer-biontech’s request to fully approve booster doses for all adults, instead signing off on a more limited population, including those 65 and older, as well as adults with underlying medical conditions or those at risk because of their jobs.
At least 30% to 40% of vaccinated adults are still excluded from booster eligibility, according to some estimates.
More than 30 million people have gotten additional shots, with the number often outpacing the number of first shots given each day around the country. Booster doses were also authorized in October for everyone who received the single-dose Johnson & Johnson vaccine, and for vulnerable groups who received Moderna’s two-dose shot.
The CDC’S gathering on Friday is scheduled to be briefer than recent meetings about COVID vaccines, just three hours, and is expected to be straightforward, one federal official familiar with the planning said, in part because of how far the nation’s booster campaign has already come. That would suggest a significant softening of opposition among public health experts since President Joe Biden announced in August that he hoped to offer booster doses to all adults.
Biden wanted to start the campaign in late September, but his announcement was heavily criticized by public health experts, who said he was rushing federal scientists and regulators who had to decide whether the data supported such a move. Members of the FDA and CDC advisory committees have said they were uncomfortable with how quickly the administration wanted to offer booster shots to a large swath of Americans.
Some key regulators and outside advisers had been hesitant to endorse a sweeping booster campaign this early, arguing that effectiveness of the two-dose regimen, especially in preventing hospitalization and death, has held up strongly. One large study in New York of nearly 9 million people has shown remarkable durability in the protection gained from all three federally authorized vaccines.
But more recently, federal regulators and scientists have said the evidence is increasingly clear that a reduction in vaccine efficacy against milder COVID cases, and in protective antibodies, has put Americans — especially seniors and those with medical conditions — at risk of harmful breakthrough infections as the delta variant of the virus only gradually loosens its grip.
“Antibodies decay with time. That’s not just a coronavirus vaccine story,” said Dr. Ofer Levy, director of the Precision Vaccines Program at Harvard’s Boston Children’s Hospital and a member of the FDA advisory committee. “Vaccines vary in the durability of the protective response. We are starting to see waning in other age groups as well.”
An Israeli study published in the scientific journal The Lancet in late October compared about 730,000 people who had received a booster dose in August
or September with individuals who had received only two doses of the Pfizerbiontech vaccine at least five months earlier, finding that boosted recipients had a lower risk of hospitalization and severe disease. Those with booster shots were evaluated between one week and nearly two months after their third dose.
Mandate lawsuits
Challenges to President Joe Biden’s COVID-19 vaccine mandate for private employers will be consolidated in the U.S. 6th Circuit Court of Appeals, a panel dominated by judges appointed by Republicans.
The Cincinnati-based court was selected Tuesday in a random drawing using ping-pong balls, a process employed when challenges to certain federal agency actions are filed in multiple courts.
The selection could be good news for those challenging the administration’s vaccine requirement, which includes officials in 27 Republican-led states, employers and several conservative and business organizations. They argue the U.S. Occupational Safety and Health Administration does not have the authority to impose the mandate.
The challenges, along with some from unions that said the vaccine mandate didn’t go far enough, were made this month in 12 circuit courts. Under an arcane system, it was up to the clerk of the Judicial Panel on Multidistrict litigation to select a ping-pong ball from a bin to choose where the cases would be heard.
It was a favorable outcome for Republicans. Eleven of the 16 full-time judges in the 6th Circuit were appointed by Republican presidents. Accounting for one of the Republican-appointed judges, Helene White, who often sides with judges appointed by Democrats and adding senior judges who are semiretired but still hear cases, the split is 19-9 in favor of Republicans. Six of the fulltime judges were appointed by former President Donald Trump.
Another court where a majority of judges were nominated by Republicans, the New Orleans-based 5th Circuit Court of Appeals, issued a ruling that put the mandate on hold.
Republican state attorneys general and conservative groups mostly filed their challenges in circuit courts dominated by conservative judges, while the unions went to circuits with more judges nominated by Democratic presidents.
In all, 34 objections have been filed in all 11 regional circuits plus the one for the District of Columbia.