FDA advisers recommend authorization of Johnson & Johnson single-dose coronavirus vaccine

[BumRushDaShow]

Source: Washington Post

An expert committee unanimously recommended Friday that the Food and Drug Administration authorize a coronavirus vaccine from Johnson & Johnson, making it all but certain there will soon be a third vaccine in the United States, the first to require just a single shot.

The positive vote, after hours of scientific discussion, paves the way for a decision this weekend. If the vaccine is authorized, the first few million doses of a shot that is relatively simple to store, handle and administer could be distributed next week.

The prospect of a third vaccine arrives the same week the United States marked the grim milestone of 500,000 deaths and at a crucial moment in the pandemic. After weeks of declining new cases, the downward trend has stalled -- a change that makes many experts uneasy that officials are relaxing restrictions and people are letting their guard down just when variants capable of spreading faster or slipping by some aspects of immunity are poised to take off.

Adding another vaccine will help bolster the nation's limited supply of the two authorized shots, one made jointly by Pfizer and its German biotech partner BioNTech and the other from Moderna. It should help accelerate the vaccination campaign, although the initial impact of the Johnson & Johnson vaccine is expected to be modest as the company ramps up manufacturing over the next month, with the first 20 million doses expected to be delivered by the end of March.

Read more: https://www.washingtonpost.com/health/2021/02/26/johnson-and-johnson-vaccine-fda/

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Have been watching the Advisory Group session much of the day and they just got done voting (unanimous approval). There were some questions about how they might want to handle attempting a 2-shot regiment given a 2nd shot of this particular vaccine, might give a higher efficacy (they are trialing it as a note).

This vaccine was created via a more "traditional" path using some type of viral material (in this case, modifying a benign adenovirus) as a jumping off point vs Pfizer/Moderna, which utilizes a novel type of vaccine with mRNA and no viral material at all (whether "live", "dead" or "fragmentary" ).

ETA - there were other issues that came up, notably how Janssen is characterizing "mild/moderate/severe" COVID, apparently using a different/perhaps "non-standard" definition, particularly compared to the other vaccine makers. One of the FDA members (PHS member Dr. Lee I believe) noted that "mild" is generally recognized to be presenting with "1 symptom" and "moderate" would be presenting 2 or more symptoms, etc. So expect they might need to modify their efficacy descriptions (and percentages).

I believe this goes to CDC next (probably tomorrow) for their review/approval and off it will go for shipping next week.

[DeminPennswoods]

1. Tapper asked Sanjay Gupta about the difference

in efficacy between the mRNA vaccines and the J&J one. He made an interesting point that the Pfizer/Moderna trials were earlier in the pandemic and therefore might not have had trial participants with the UK/SA variants like the J&J one has. But he stressed they are ALL good vaccines.