J&J has asked the Food and Drug Administration for flexibility with its booster, arguing the extra dose adds important protection as early as two months after initial vaccination - but that it might work better if people wait until six months later.
Thursday, advisers to the Food and Drug Administration evaluated the evidence that Moderna boosters should be offered, too -- and on Friday, they’ll tackle the same question for those who got Johnson & Johnson’s vaccine.
The new rules, announced Wednesday, will allow fully vaccinated foreign nationals to enter the U.S. regardless of the reason for travel starting in early November, when a similar easing of restrictions is set to kick in for air travel into the country.
9,588,161 PCR tests have been conducted in Virginia as of Wednesday, with a 7.6% positivity rate from those tests over the last week, down from the 7.8% reported Tuesday.
On Thursday and Friday, the Food and Drug Administration convenes its independent advisers for the first stage in the process of deciding whether extra doses of the two vaccines should be dispensed and, if so, who should get them and when. The final go-ahead is not expected for at least another week.
If cleared by the Food and Drug Administration — a decision that could come in a matter of weeks — it would be the first pill shown to treat the illness. All other FDA-backed treatments against COVID-19 require an IV or injection.
In the coming weeks, more than 100 million Americans will be subject to vaccine requirements ordered by Biden. And his administration is encouraging employers to take additional steps voluntarily that would push vaccines on people or subject them to onerous testing requirements.
Sweden suspended the use of Moderna for those recipients under 30, Denmark said those under 18 won’t be offered the Swiss-made vaccine, and Norway urged those under 30 to get the Pfizer vaccine instead.
According to the FDA, certain lots of the test indicate that a person has the virus when they do not actually have it. Negative results do not appear to be affected by the manufacturing issue.
The company said it will soon ask health officials in the U.S. and around the world to authorize the pill’s use. A decision from the U.S. Food and Drug Administration could come within weeks after that, and the drug, if OK’d, could be distributed quickly soon afterward.
Addressing a slew of state cabinet secretaries, Virginia’s Vaccine Coordinator said early November is now when we can expect approval of Pfizer’s COVID-19 vaccine for those aged 5 to 11.
Last week, CDC Director Dr. Rochelle Walensky sided with most of the recommendations from CDC advisers on giving boosters six months after the last Pfizer dose for certain groups of people.
With more than 40 million doses of coronavirus vaccines available, U.S. health authorities said they’re confident there will be enough for both qualified older Americans seeking booster shots and the young children for whom initial vaccines are expected to be approved in the not-too-distant future.
