FDA Vaccine Advisers Support Moderna Half-Dose Booster For Many
A covid vaccine booster is appropriate for people over 65 and those with jobs or health conditions that put them at high risk, the Food and Drug Administration's advisory panel unanimously recommended Thursday. The members continue to meet today to discuss a possible Johnson & Johnson second shot.
Stat:
FDA Advisory Panel Endorses Moderna's Covid Booster For Some Groups
A Food and Drug Administration advisory panel voted unanimously Thursday in favor of authorizing booster shots of the Moderna Covid-19 vaccine to people 65 and older, those 18 to 64 with risk factors for severe Covid-19, and those whose jobs put them at high risk for serious complications of Covid-19, such as health care workers. After hours of deliberation, the Vaccines and Related Biological Products Advisory Committee voted 19-to-0 that the Moderna booster should be authorized for these groups at least six months after receiving their second dose. The panel also discussed at what point boosters should be recommended to all adults over 18, saying that at this point it is far too soon to consider the matter. (Herper and Branswell, 10/14)
The Wall Street Journal:
Moderna Booster Shot Backed By FDA Advisory Panel
Moderna said the booster doses can be drawn from the same vials that contain the original two-dose vaccine series, meaning the boosters will be available soon after authorization. Members of the FDA’s vaccine-advisory panel supported Moderna’s booster dose even though the evidence for it was from a small study and had mixed results. (Schwartz and Loftus, 10/14)
AP:
FDA Panel Endorses Lower-Dose Moderna COVID Shot For Booster
The recommendation is non-binding but it’s a key step toward expanding the U.S. booster campaign to millions more Americans. Many people who got their initial Pfizer shots at least six months ago are already getting a booster after the FDA authorized their use last month — and those are the same high-risk groups that FDA’s advisers said should get a Moderna booster. But there’s no evidence that it’s time to open booster doses of either the Moderna or Pfizer vaccine to everybody, the panel stressed — despite initial Biden administration plans to eventually do that. (Neergaard and Perrone, 10/14)
Politico:
FDA Advisers Endorse Moderna Booster Shot: Three Takeaways
The Moderna plan endorsed by the panel would apply to largely the same groups currently eligible for the Pfizer-BioNTech booster shot. For now, federal regulators only are planning to endorse giving people boosters from the same manufacturer as their initial shots, though the independent advisers will review preliminary data on Friday on so-called “mix-and-match” boosting. The FDA panel’s Friday meeting will also take up of Johnson & Johnson’s proposed booster. (Gardner, Owermohle, Foley and Morello, 10/14)
And in updates on the Johnson & Johnson booster shot —
Stat:
Follow The FDA Advisory Panel Meeting On The J&J Covid Vaccine Booster
The booster-shot question that has been on the top of many minds for many months will be addressed today when the Food and Drug Administration’s vaccines advisory committee reconvenes to complete a two-day meeting. The question before it: Should people who got the one-dose Johnson & Johnson vaccine get a booster shot, and if so, when? Another top-of-mind question, however, may end up not being addressed by the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC). If the highly active discussion on Twitter is any indication, people who got the J&J vaccine want to know if they should be boosted with one of the messenger RNA vaccines from Pfizer-BioNTech or Moderna. (Branswell and Herper, 10/15)
