Pfizer says a booster shot will be needed in the future; FDA & CDC retort that it's not needed now.

[Towlie]

Bad CNN headline: Pfizer says it's time for a Covid booster (No, that's not what they say); FDA and CDC say not so fast

Drugmaker Pfizer said Thursday it is seeing waning immunity from its coronavirus vaccine and says it is picking up its efforts to develop a booster dose that will protect people from variants.

...

But in an unusual move, two top federal agencies said Americans don't need boosters yet...

It's like telling a skydiver that he'll need to open his parachute in the future, and the skydiver angrily retorting that no, he's falling freely and doing just fine.

[FBaggins]

1. No. It isn't like that at all

The need for booster doses is entirely speculative at this point as vaccine immunity has been remarkably stable over time so far.

It isn’t irrational speculation (they may be needed)… but it’s far from the certainty that your illustration implies.

[LisaL]

5. So you think you know more than Pfizer?

NT

[temporary311]

8. I think Pfizer has financial incentive to push boosters.

I'm not aware of any study showing that they're necessary yet.

[LisaL]

10. And CDC wants to pretend that everything is back to normal as far as I am concerned.

In both Israel and UK, a lot of vaccinated people have been getting infected with delta.

[krawhitham]

28. +1

[Hugin]

67. +12

[RobinA]

25. That Could Be

an issue, for sure. I am paying attention to this, because I got vaccinated on the third day it was available. December 2020. So I will need a booster, if anyone needs a booster, in the first wave. I'm hoping my workplace (where I got vaccinated) is on top of this.

[FBaggins]

12. Nope. I think I know how to read what they said better than you did.

Nowhere do they claim that a booster will be required.

They merely see early signs that hint that it might at some point in the future and they're preparing for that eventuality.

[LisaL]

13. They are saying a booster six months after second dose works well.

Not some undetermined time into the future. They plant to ask for authorization to provide a third dose 6 to 12 months after the first two doses.

"Pfizer and BioNTech have released initial data from a study on booster shots for their COVID-19 vaccine, saying a third dose delivered about six months after the second shot has shown neutralization titers are five to 10 times higher than after two primary doses."

https://abcnews.go.com/Health/booster-shot-12-months-provide-best-protection-covid/story?id=78741334

[FBaggins]

20. "Works well" does not mean "and thus everyone will need it in a few months"

Also... the measure of "works well" (antibody counts in the absence of the virus) is not the only way that the vaccines produce immunity. It has already been shown that protection against serious infection persists well after antibody counts have declined.

[LisaL]

22. Well, you don't have to get it.

You can count on your declining antibodies from first two shots to do the trick.

[FBaggins]

30. Antibody levels absent an infection aren't necessarily a good measure of your immunity to COVID

Antibody counts may impact your ability to shrug off infection upon exposure, but the true measure of immunity is your body's ability a create antibodies (and other immune responses) in response to an infection. The only good way to measure that is to watch breakthrough infections over time.

It's entirely possible that antibody counts fall over time yet immunity from serious illness remains strong. In fact, this appears to be exactly what has happened so far (as evidenced by slightly increasing breakthrough infection numbers, but continuing low counts of serious illness).

Either way... it has nothing at all to do with your misreading of what Pfizer is saying compared to what the CDC is saying. They aren't contradictory. Pfizer tells us that their booster development is coming along well and the CDC is telling us that there is not currently evidence that they're more likely to be needed than not (or something in between like boosters for those over 70, etc.).

[MisterNiceKitty]

32. +1 lol

[Mariana]

36. This is what Pfizer knows, according to the story at the link:

Based on the totality of the data they have to date, Pfizer and BioNTech BELIEVE that a third dose MAY BE beneficial within 6 to 12 months following the second dose to maintain highest levels of protection.

It's important to read all of the words.

[Dorian Gray]

39. Both Pfizer

and the CDC should be focusing on vaccinating the unvaccinated first. Once we've done that in a more equitable way, we can talk boosters.

[LisaL]

44. So we should prevent people who want to get the third shot

because of people who refuse to get the first two? Why exactly?
As far as I am concerned anti-vaxxers made their bed and they should be allowed to lie (or die) in it.

[Dorian Gray]

47. No we shouldn't prevent people

if a booster is indicated an actual point, they should be made available.

But there is a whole world out there that doesn't include our vaccine hesitant MAGA Americans. Many of those people would love a vaccine and have no access to it. We should be exporting to countries that don't have it. (We have started doing that, of course, but in reading the news about Haiti and their president being killed, it's clear that they haven't received any vaccine shipments! Why?)

You'll eventually get your booster. Don't worry. But as I've stated in my other posts, the messaging sucks and it will do a lot to hinder the vaccination efforts. Mixed messaging for the country. It'll make some people panic while making other people dig their heels in.

[Mariana]

55. There isn't even a third shot to get at this time.

How can anyone prevent you from getting something that doesn't exist?

[LisaL]

57. Oh for crying out loud.

You could get the same shot as the first two.
That in itself increases antibodies 5-10 fold.

[EarlG]

2. Is this really a controversy?

Pfizer says it will "soon publish data about a third dose of vaccine and submit it to the US Food and Drug Administration, European Medicines Agency and other regulators."

FDA says, "Americans who have been fully vaccinated do not need a booster shot at this time."

WHO says, "We don't know whether booster vaccines will be needed to maintain protection against COVID-19 until additional data is collected."

Why is this being reported as if there's some kind of fight between Pfizer, the FDA, the CDC, and the WHO? They all seem to be on the same page. Seems like until the agencies get more data -- which Pfizer hasn't provided them with yet -- they're not going to change their current policy.

"We continue to review any new data as it becomes available and will keep the public informed. We are prepared for booster doses if and when the science demonstrates that they are needed," the CDC and FDA said in the statement.

Am I missing something?

[JohnSJ]

3. +++

[LisaL]

6. As far as I can tell, CDC just wants to pretend that covid is over.

And vaccines that we already have are perfect. And that won't change with time.

[EarlG]

7. Pretty sure that's not what's going on...

"We continue to review any new data as it becomes available and will keep the public informed. We are prepared for booster doses if and when the science demonstrates that they are needed," the CDC and FDA said in the statement.

[LisaL]

11. I rather get the booster before a large number of vaccinated people becomes infected.

Which is already happening in UK and Israel.

[lagomorph777]

24. Media creating a fake controversy.

Of course we'll need updates to keep up with the red-state variant breeding programs.

And if effectiveness against the original version is already waning, yes, also a booster.

Eventually.

[muriel_volestrangler]

27. This affects what use the production capacity is put to

If the US decides to manufacture booster shots soon, then it won't be making first/second shots for the rest of the world.

I don't think Pfizer is on the same page as the authorities; Pfizer says "Pfizer and BioNTech believe that a third dose may be beneficial within 6 to 12 months following the second dose to maintain highest levels of protection", while the FDA says "FDA, CDC, and NIH (the National Institutes of Health) are engaged in a science-based, rigorous process to consider whether or when a booster might be necessary. This process takes into account laboratory data, clinical trial data, and cohort data -- which can include data from specific pharmaceutical companies, but does not rely on those data exclusively".

Giving boosters from 6 months after the 2nd dose means manufacturing them right now.

[LisaL]

56. Here is CDC's logic.

It is expected that a small percentage of vaccinated people is going to die from covid. How small? It it not worth it to prevent those people from dying (or getting sick) by giving a booster?

"Vaccine breakthrough cases are expected. COVID-19 vaccines are effective and are a critical tool to bring the pandemic under control. However, no vaccines are 100% effective at preventing illness in vaccinated people. There will be a small percentage of fully vaccinated people who still get sick, are hospitalized, or die from COVID-19."
https://www.cdc.gov/vaccines/covid-19/health-departments/breakthrough-cases.html

[muriel_volestrangler]

58. Notice there is nothing saying "boosters will prevent this"

It is undisputed that first (and second, for Pfizer) doses save lives. We do not yet have the evidence that third doses do.

The CDC's logic is sound.

[Initech]

59. Yes they've been saying this since the beginning. I'm planning for it.

I don't get why this is a controversy.

[Hoyt]

4. If needed, they'll likely do it through private doc offices just like annual flu shot. I'll be there

[Zeitghost]

9. I'm quite sure

Pfizer would love to sell as many boosters as they can for years to come. The CDC and other independant entities in the medical community will determine if that is necessary.

[LisaL]

14. And CDC apparently prefers to pretend that everything is just fine.

It will actually cost the government money to offer boosters, no? But you are not suspicious of that motivation?

[muriel_volestrangler]

31. You're more suspicious of government employees who will not get bonuses

for not recommending boosters, than of Pfizer employees who will get bonuses if the company gets to sell them? I don't think you've thought this through.

I note you have unjustly accused the CDC of "pretending". "Apparently".

[Hoyt]

33. If needed, glad they are working on the booster. Won't be surprised if it's needed,

unless the need for a booster is viewed as a hoax.

[LetMyPeopleVote]

15. Americans who have been fully vaccinated don't need a booster shot at this time,

Link to tweet

[LisaL]

16. I don't need covid either.

I don't particularly care for getting a mild version of covid, which CDC apparently thinks is totally acceptable.

[Treefrog]

18. Same here. I had the "mild" Covid, which involved running a fever of 104 for most of a week.

It also included delightful symptoms like severe headache, horrible body aches, and extreme weakness.

[totodeinhere]

34. I cannot find anywhere where the CDC says that getting a mild case of Covid is acceptable.

If you have link please provide it.

What they are saying is that getting a mild case is preferable to a more serious case requiring hospitalization or resulting in death. Who could argue with that? But of course not getting it in the first place is the best option if possible.

[LisaL]

37. Vaccinated people are told they don't need to wear masks.

Vaccinated people can still get break through infections, but those infections are usually milder.
So, it would appear to me that CDC thinks mild infections are acceptable, no?

[Dorian Gray]

48. Keep wearing your mask in public places

I live in NYC and I do. On public transport. In stores. It's a way to prevent that breakthrough infection.

[totodeinhere]

61. I did not get that impression. Saying that breakthrough infections are usually

milder, which is true, doesn't mean that getting a breakthrough infection is acceptable. And breakthrough infections are rare enough that it probably does not rise to the level of needing a mask. Going through life means taking acceptable risks. Otherwise we couldn't do almost anything. I could not drive to work tomorrow because of the slight risk that I may get in an automobile accident on the way to work. I am not going to spend my life cowering at every remote possibility.

[BannonsLiver]

17. Picking up a Trumpy anti government vibe in some of the responses.

[Yavin4]

19. FDA and CDC are primarily concerned with getting people their first 2 doses.

They don't want a message about a 3rd dose clouding up their messaging.

[LisaL]

23. Are they planning on giving anti-vaxxers new brains?

Seem pretty obvious anti-vaxxers rather get covid than vaccine.

[Yavin4]

26. The FDA needs to give full approval to the vaccines.

And then let employers, schools, and insurance companies deal with the anti-vaxxers.

[Dorian Gray]

40. This....

Until there is full FDA approval for the vaccine and the boosters go through the regular approval process, communities will be resistant. The news that Pfizer was talking about a third shot/booster did two things for the anti-vaxxers yesterday: a) They were able to tell the narrative that the first two shots don't do enough and b) this is a money grab by big pharma.

Those two narratives are two of the most detrimental to the medical/science community and the vaccine outreach efforts. I"m wary of anybody pushing them.

Yes, we may need boosters. Scaring people into trying to get them NOW is wrong.

[LisaL]

42. We have some people who are at 6 months after their second dose.

So they would need the boosters now per Pfizer.
I don't know WTF we are supposed to be waiting for. Not to scare anti-vaxxers with a third shot? They won't get the first two anyway. People who want a booster should be able to protect themselves without worrying about ant-vaxxers' feelings.

[Dorian Gray]

45. Pfizer

stated that they are studying this. The information was unfortunate because there are people out there (like in your post) who are riling people up that we NEED a third shot NOW! Panic. Panic. OMG!

That is detrimental to the vaccine efforts.

Especially because it is NOT actually indicated now and you can't get a third shot now.

Stop the panic.

It's good that Pfizer is going to study this and show the efficacy of a third booster shot.

If you got your shot, you're okay.

If you want the third shot now, you're not going to get it yet.

[LisaL]

53. Pfizer already studied the third shot.

A third shot six months after the second shot increases antibodies 5-10 times.
They are not just making this shit up like some of you are making it sound.

[Dorian Gray]

60. Article

https://www.nytimes.com/2021/07/08/health/pfizer-booster-delta-variant.amp.html


It’s
Essentially a press release. We may need. We may lose immunity after 6 months. They’re developing a booster. They’re developing a delta specific shot.

It’s not available now.

You can’t get it.

Their preliminary studies show that a booster after six months may boost your immunity 5-10 fold yes. But that shot is not indicated yet. The Pfizer studies aren’t peer reviewed or published.

Nobody is walking into a vax site and getting a 6 month booster with the info that has been released.

And our govt has the moral imperative to get everyone who hasn’t been vaccinated to consider a vaccine. (Including our kids. I’d rather get my ten year old her vaccine before I take a booster).

[Devil Child]

21. I'll turn to Biden administration's FDA and CDC before turning to Pfizer for strategic goal setting

I think the skydiver knows the situation and will pull the chute when needed.

[LisaL]

38. Numbers are already going up in the US.

Seems little doubt it is going to get worse.

[Dorian Gray]

41. Yes

so they should push and promote vaccine in vaccine hesitant areas.

[LisaL]

43. Unless you gonna dart them with the vaccine,

they aren't keen on getting it.

[Dorian Gray]

46. I have a friend

who got it because she want to go to the Foo Fighters concert. People get it or don't get it for all sorts of reasons.

A Big PR push, having doctors call their patients to get it, and make it as simple as possible for marginalized communities will go far.

Nobody is getting a third shot until the efficacy is proven through studies.

[OnDoutside]

50. Exactly.

Here in Ireland, I'm hearing a lot of people who said they weren't getting the vaccine, are now getting it because they want to go on holiday to Spain, Portugal, Italy etc. The EU have issued a Covid passport for those travelling.

The EU COVID Certificate (DCC) will help citizens move freely and safely within the EU during the COVID-19 pandemic.

It is proof that you have either:

Been vaccinated against COVID-19;
Received a negative test result; or
Recovered from COVID-19 in the last 6 months

Stuff like that tends to concentrate the mind !!!

[UTUSN]

29. K&R

[OnDoutside]

49. Nothingburger. Both statements are true.

[Shermann]

51. Pharmaceutical companies don't like competing against their own products

In the case of generics, they change their formulations slightly in order to get new patents. Then they campaign against the old formulations and tell us the new formulations are more effective.

In the case of vaccines, they change the vaccines slightly in order to create new boosters. Then they campaign against the old vaccines and tell us the new boosters are more effective.

Do you see a pattern here?

[Azathoth]

52. This is a tough one. Pfizer has a profit motive, the CDC has a bad track record

of being either late to the party, or else making recommendations based on broader policy concerns rather than individual people's health (eg. masks).

The data will have to speak for themselves.

[LisaL]

54. Giving a third shot six months after the second shot increases antibodies

5-10 fold.
That speaks for itself.

[Strelnikov_]

65. I will be at 6 mo. in mid-Oct.

Based on the studies conducted to date, I plan on getting a third shot around that time, by whatever means possible. I want my immune system at defcon 2 for the fall surge.

I may even try to get one by mid-August, in time for the great midwestern state fair die-off.

[LisaL]

66. I want a booster too.

I got Moderna, but it seems not to matter to get the exact same booster as your original shots.

[LetMyPeopleVote]

62. My son is in the Pfizer trial and has been asked to participate in booster trial

[LisaL]

63. Cool.

Has he gotten the third shot yet?

[LetMyPeopleVote]

64. His next appointment is in late august

Which will also be the anniversary of his second shot