FDA and the covid booster jab

[mysty]

2000 Americans are dying per day from Covid, the FDA just advised against the booster.

Taken from Yahoo breaking news


A U.S. Food and Drug Administration (FDA) advisory panel voted Friday against approval of Pfizer (PFE)/BioNTech's (BNTX) third dose for the U.S.

The vote comes after a heated debate in recent weeks over the need for booster or additional shots, which both mRNA companies — Pfizer and Moderna (MRNA) — have advocated for.

Dr. Peter Marks, the FDA's leading expert on vaccines, touched on the controversy in his introductory remarks.

"We know that there may be differing opinions of the interpretation of the data regarding the potential need for additional doses, and we strongly encourage all the different viewpoints to be voiced and discussed regarding the data, which is complex, and evolving," Marks said.

He added the meeting focused on almost real-time analyses compared to what is happening in the world, and the goal remains slowing the spread of COVID-19, which is killing almost 2,000 Americans daily.

The question the advisory panel was given to consider only used the U.S. data, a small dataset, despite the presentations including data from the U.K. and Israel.

Marks instructed the panel to consider all the data, noting, "This is not a legal proceeding, this is a science proceeding, so you can take all the data into account."

The meeting precedes a September 20 start date for additional doses, announced last month by the White House COVID-19 Response Team, despite U.S. Centers for Disease Control and Prevention (CDC) data showing some Americans are already receiving third doses. Last month, the CDC recommended additional doses for immunocompromised people.

A CDC advisory panel will meet next week to discuss recommendations for who should receive a booster dose.

At a Response Team briefing Friday, U.S. Surgeon General Dr. Vivek Murthy said the administration is already communicating with pharmacies, nursing homes and state officials to help roll out additional doses.

But whether or not the average American also needed boosters had been a growing debate for weeks.

Measuring antibody levels after a vaccine, which tend to wane, versus relying on memory cells, which can recall how to fight the virus, as is typical in vaccinations, was at the heart of the debate in the science community.

A Pfizer official acknowledged that "its a much more complex story" than just antibody titers — even as the company relied on that data to advocate for additional doses.

Meanwhile, some who opposed third doses believed those doses could be better used in countries with low vaccination rates.

Marks also addressed that at the start of the meeting Friday, noting that the committee is only supposed to weigh on the data and need for shots, and not on global vaccine equity or operational concerns in rolling out a booster campaign in the U.S.

The decision Friday heavily leaned on data from Israel, as well as the U.K., which has been a point of concern.

[Blaze]

What doesn't seem to be clear from the Yahoo news item is who is dying from Covid in the US : are they unvaccinated, in which case the 3rd vaccination is irrelevant. Or are they people who have been vaccinated but who have little or no immunity. I would guess the former as from what I have read, just over half of the population have had 2 doses of vaccine.

[mysty]

What doesn't seem to be clear from the Yahoo news item is who is dying from Covid in the US : are they unvaccinated, in which case the 3rd vaccination is irrelevant. Or are they people who have been vaccinated but who have little or no immunity. I would guess the former as from what I have read, just over half of the population have had 2 doses of vaccine.

According to this site almost all that are dying are unvaccinated.
If you cannot read the link just click the x to open it up. You don't need to pay.

https://apnews.com/article/coronavirus- ... 54f5d5e187

[Blaze]

According to this site almost all that are dying are unvaccinated.

That article is dated 29 June 2021 and states that under 300 people a day are dying ...
It's unsurprising since it's been shown that the number of deaths has plummeted since the introduction of the vaccine.
Those dying in the US are likely to be obese, have health issues and/or are of an ethnic origin which is vulnerable to Covid. They would not be eligible for the booster vaccine anyway.
There are two different issues in the US : being vaccinated in the first place and whether or not there will be a 3rd, booster jab.

[niemeyjt]

Given Israel was ahead of the game on vaccination, and is now suffering another wave as immunity wears off, I would have thought boosters are desirable.

I am surprised they are not happening everywhere in mainland Europe - though I guess as vaccinations were delivered later so maybe immunity has tailed off less?

As I have said before, I am planning to visit the UK for a booster and a flu jab if I cannot get them here in time.

[Blaze]

France is inviting people for boosters but this is done 6 months after the 2nd jab.

[Doug]

France is inviting people for boosters but this is done 6 months after the 2nd jab.

Yes I stated on the other post that weve got an invite to register
but have till November for the jab.

[niemeyjt]

As I have said before I see annual boosters becoming a fixture - maybe one day as a combo with flu - and maybe tweaked like the flu as well for the variants.

I am not sure if Pfizer have tweaked the vaccine for new variants or if it is the same as it was in May - or even if they are allowed to without fresh approvals?

[Blaze]

At the centre we're only vaccinating for Covid. Numbers are dwindling as almost everyone here has had at least one vaccination and those eligible for a 3rd are trickling through (the 3rd vax is given 6 months after the second). This centre will be open only 3 days a week from the end of September and if it closes at the end of the year (or before), people will be invited to go to their doctor for a booster. Perhaps by then we will know whether the booster will be combined with the flu jab, given that the decision re the flu jab strain may not have been finalised yet.

[rabbit]

What doesn't seem to be clear from the Yahoo news item is who is dying from Covid in the US : are they unvaccinated, in which case the 3rd vaccination is irrelevant. Or are they people who have been vaccinated but who have little or no immunity. I would guess the former as from what I have read, just over half of the population have had 2 doses of vaccine.

According to this site almost all that are dying are unvaccinated.
If you cannot read the link just click the x to open it up. You don't need to pay.

https://apnews.com/article/coronavirus- ... 54f5d5e187

(Reuters) - Advisers to the U.S. Food and Drug Administration voted on Friday to recommend COVID-19 vaccine booster shots for Americans 65 and older and those at high risk of severe illness, after overwhelmingly rejecting a call for broader approval.