Overnight Health Care — COVID-19 vaccine for young kids delayed
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A woman who lives outside of Boston managed to win a free vacation on the Price is Right … all the way to New Hampshire.
The FDA is delaying its decision on authorizing Pfizer’s vaccine for young kids because it needs more data on a third dose.
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FDA delays vaccine decision for kids under 5
The Food and Drug Administration (FDA) is delaying a decision on whether to authorize Pfizer and BioNTech’s coronavirus vaccine for children under five years old, because there’s not enough data on the efficacy of a third dose. An FDA advisory panel meeting scheduled for next week has been postponed.
“Based on the agency’s preliminary assessment, and to allow more time to evaluate additional data, we believe additional information regarding the ongoing evaluation of a third dose should be considered as part of our decision-making for potential authorization,” the FDA said in a statement.
The decision to extend the data submission and delay the advisory panel meeting pushes back the timeline for authorizing COVID-19 shots for kids under five, a major blow to parents of young kids.
The companies said they don’t expect to have three-dose protection data available until early April.
The delay likely indicates the agency did not have data that showed two doses was enough, though the FDA’s Peter Marks, head of the division responsible for vaccine safety, did not say what prompted the decision.
Two shots vs. three: Pfizer earlier this month began applying for emergency use authorization of its vaccine in kids ages six months to four years old, at the FDA’s request. But though the company said three doses will eventually be needed, the application was only for two doses.
The companies have been testing a third shot after announcing in December that trial data showed two doses produced an insufficient immune response in toddlers over the age of 2. However, data showed two doses was sufficient in children between 6 months and 2 years old. Read more here.
CDC study: Booster wanes after 4 months
The study, released by the Centers for Disease Control and Prevention (CDC) Friday, found that booster shot effectiveness against hospitalization with the omicron variant was 91 percent after two months, but waned to 78 percent after four months.
Protection against emergency department or urgent care visits declined from 87 percent to 66 percent after four months. It was just 31 percent after at least five months, though the study cautioned that finding was “imprecise because few data were available.”
Vaccine effectiveness was always higher after three doses than after two, so people are still urged to get a booster shot.
Fourth dose needed? The finding of some waning in booster shot effectiveness could inform discussions of the possible need for additional shots.
“The finding that protection conferred by mRNA vaccines waned in the months after receipt of a third vaccine dose reinforces the importance of further consideration of additional doses to sustain or improve protection against COVID-19–associated [Emergency Department/Urgent Care] encounters and COVID-19 hospitalizations,” the study states.
Speaking earlier this week at a press briefing, President Biden‘s chief medical adviser, Anthony Fauci, said data is being monitored closely on metrics like protection against hospitalization when it comes to deciding whether a fourth dose is needed. Another shot might not be necessary for everyone, he said.
“There may be the need for yet again another boost — in this case, a fourth-dose boost for an individual receiving the mRNA — that could be based on age, as well as underlying conditions,” he said.
FDA AUTHORIZES ANOTHER ANTIBODY TREATMENT TO FIGHT OMICRON
The Food and Drug Administration (FDA) on Friday authorized a new antibody treatment from Eli Lilly, adding another option for fighting the omicron variant.
The FDA said the treatment, called bebtelovimab, works against omicron and is authorized for treatment of mild or moderate COVID-19 in people 12 and older who are at high risk for severe disease.
The agency limited its recommendation by saying it should be used in patients “for whom alternative COVID-19 treatment options approved or authorized by the FDA are not accessible or clinically appropriate.”
Another antibody treatment from GlaxoSmithKline and Vir Biotechnology has already been authorized to work against omicron. Two others, from Regeneron and a different product from Eli Lilly, were restricted after being found to not be effective against the omicron variant.
“Today’s action makes available another monoclonal antibody that shows activity against omicron, at a time when we are seeking to further increase supply,” said Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research.
On Thursday, the Biden administration announced that it had purchased 600,000 doses of the treatment to be distributed for free. The first 300,000 doses are expected in February and the second half in March.
AMERICANS BRACE FOR CANADA-STYLE PROTESTS
The trucker-led protest against COVID-19 restrictions in Canada is spreading — and American political observers of all stripes believe something similar is bound to take hold in the United States.
If that happens, it will add one more fractious clash to the American debate over COVID-19, which is already so bitter and polarized.
It will also come at a point when President Biden is in a tricky political spot.
The public is impatient to return to some semblance of normalcy and Democratic-led states are lifting mask mandates, but Biden is adhering to the more cautious positions advocated by the Centers for Disease Control and Prevention (CDC).
Tentative plans are taking shape for an American equivalent to the Canadian “Freedom Convoy” that was initially centered on Ottawa but has expanded to three border crossings.
The most prominent American plan, though still unconfirmed, is for a “People’s Convoy” that would travel from California to Washington, perhaps in early March.
Republican politicians, including former President Trump, have expressed support for the Canadian truckers, whose actions have also become a rallying point among conservative media personalities in the U.S.
Biden: states easing mandates ‘probably premature’
President Biden said Thursday that decisions by a growing number of states to lift mask mandates are “probably premature” but acknowledged that such decisions are a “tough call.”
In an interview with NBC’s Lester Holt, Biden seemed to try to avoid directly criticizing governors for easing mask mandates, but stood by the Centers for Disease Control and Prevention’s (CDC) recommendation for masking in much of the country.
“The science is saying now masks work, masks make a difference,” Biden said.
“I committed that I would follow the science, the science as put forward by the CDC and the federal people,” Biden said later. “I think it’s probably premature but it’s a tough call.”
Biden acknowledged that the current patchwork of guidance at the federal and state and local level is “confusing” but suggested that the need for masks, especially in schools, might ease once the COVID-19 vaccines are approved for younger children.
A number of Democrat-run states this week announced plans to lift or ease mask mandates in at least some settings. These states included Connecticut, New Jersey and Massachusetts, which are lifting mask mandates in schools.
Some states are opting for a phased approach as the wave driven by the omicron coronavirus variant subsides, which Biden noted in his answer to Holt.
Still, the developments have put the White House in an awkward position.
WHAT WE’RE READING
- Fight over opioid prescribing — and when it turns criminal — heads to Supreme Court (Stat)
- What are taxpayers spending for those ‘free’ Covid tests? The government won’t say (Kaiser Health News)
- Even among the vaccinated, Covid-19 prompted a surge of sick days (Wall Street Journal)
STATE BY STATE
- NYC’s unvaccinated workforce faces termination today without proof of shots (NBC New York)
- Kansas Republicans tie remap law to pro-ivermectin measure (AP)
- Michigan counties rescinding school mask orders; Oakland and Washtenaw to lift mandate Feb. 28 (Fox 28)
That’s it for today, thanks for reading. Check out The Hill’s health care page for the latest news and coverage. See you Monday.
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