The Food and Drug Administration's Vaccines and Related Biological Products Advisory Committee is now holding a meeting to consider Pfizer's coronavirus vaccine, which has already gotten authorization from officials in Canada and the UK.
In the United Kingdom, the Medicines and Healthcare products Regulatory Agency (MHRA) issued precautionary advice that anyone who has a history of "significant" allergic reactions to medicines, food or vaccines should not receive the vaccine now. British authorities cleared the vaccine for use last week, as did Canada on Wednesday.
THE FIRST person in the world to receive the fully-tested and approved coronavirus vaccine has left hospital in good spirits.
The meeting of outside advisers to the Food and Drug Administration represented the next-to-last hurdle before the expected start of the biggest vaccination campaign in USA history.
"But we've worked many rehearsals and planning cycles ... and that's why I'm confident that as soon as EUA (emergency use authorization) comes aboard, we'll start packing to the final destinations and distribution will begin within 24 hours", Perna said.
In a recent interview, Dr. Hahn said the plan is to take the panel's recommendation into account before the FDA makes its own decision.
Once approval is given by the European Union regulatory body, the rollout of the vaccine could start in the Republic as early as next month.
Vaccines and supplies are being dispatched to 636 locations across 64 state and regional jurisdictions, officials said. FDA officials hope the discussion will show the care with which the vaccine's safety has been reviewed-part of a broader effort to convince the public that the vaccine hasn't been rushed to market for political expediency.
Bruce Gellin, president of global immunization at Sabin Vaccine Institute, which promotes vaccine adoption and trains immunization professionals, said the FDA should get credit for being transparent for its review process, including making public its analysis, which other countries don't necessarily do.
A further report of a possible allergic reaction following immunisation was also received by the MHRA.
FDA reviewers noted four cases of Bell's palsy that occurred among people getting the vaccine.
"We must build a trust in American people", he said.
But it's unclear how well the vaccine works in people with HIV and other immune-system disorders.
The study excluded pregnant women, but experts were expected to tease apart the data for any hints in case women get vaccinated before realizing they're pregnant.
Dr. Messonnier said that such longer-term study will focus on whether children under 16 can benefit from this or other vaccines.
Answering some of these questions will require keeping Pfizer's study going for many more months. Until Pfizer receives full approval, the FDA still considers the vaccine experimental and does not allow the company to market the product.
IRISH REGULATORS HAVE said comprehensive advice will be given if the Pfizer/BioNTech Covid-19 vaccine is approved in Ireland, following the UK's warning that people who have a history of "significant" allergic reactions should not now receive the jab.
The FDA still hasn't made clear if it will accept that approach.
"I gave permission to already distribute syringes and needles, alcohol wipes, and diluent - which is required in support of the Pfizer vaccine", U.S. Army Gen. Gus Perna said during a press briefing.