Coronavirus vaccine for young children further delayed as FDA says it will wait for data

[BumRushDaShow]

Source: Washington Post

The Food and Drug Administration announced Friday it will not make a decision on whether to authorize a coronavirus vaccine for children younger than 5 until data on a third dose is available, a delay that means it could be mid-April at the earliest before shots are available for that age group. The agency said it would not proceed with authorizing two doses of the Pfizer-BioNTech vaccine for young children after data from a trial showed it did not generate strong protection. “Based on the agency’s preliminary assessment, and to allow more time to evaluate additional data, we believe additional information regarding the ongoing evaluation of a third dose should be considered as part of our decision-making for potential authorization,” the agency said in a statement.

Pfizer and its partner, BioNTech, said they would have data on the three-dose regimen in early April. The delay is sure to be a bitter disappointment to the many parents who have been waiting anxiously for inoculations for children younger than 5. “Given that the study is advancing at a rapid pace, the companies will wait for the three-dose data as Pfizer and BioNTech continue to believe it may provide a higher level of protection in this age group,” the companies said in a statement. “This is also supported by recent observations of three dose booster data in several other age groups that seems to meaningfully augment neutralizing antibody levels and real world vaccine protection for omicron compared to the two-dose regimen.”

Late last month, the FDA asked the vaccine makers to submit data for the two-dose regimen for young children. The idea was for regulators to start reviewing the information in hopes that a two-shot vaccine would be at least somewhat beneficial, and to issue an emergency use authorization for the shots. Officials indicated at the time that accelerating the process meant the vaccine could be available by the end of February. It was widely expected that once the data on third shots became available, the FDA would authorize the vaccine as a three-dose regimen.

People familiar with the process said at the time that it was important to speed up the process as much as possible to offer protection to the youngest children. And the individuals, who spoke on the condition of anonymity to discuss internal deliberations, said there were indications the two-dose vaccine might be efficacious. The data showed the vaccine is extremely safe, they said. But a close review of additional data, which concluded Friday, showed that the two-dose regimen was not protective, the agency said. The FDA decided to postpone an expert advisory panel meeting that had been scheduled for Tuesday to scrutinize the vaccine’s performance in children.

Read more: https://www.washingtonpost.com/health/2022/02/11/covid-vaccine-young-children-delayed/

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Full headline: Coronavirus vaccine for young children further delayed as FDA says it will wait for data on three doses

[Bleacher Creature]

1. I feel for those parents.

And I don't really understand why they can't go forward with the two-dose approval if the process for the third dose is right behind it. It's not a safety issue for the first two doses - i.e., it's only a matter of efficacy.

The only reason why I would think it makes sense to wait is if they wanted to explore upping the dose for the first two shots, but I don't think that's the case here.

[BumRushDaShow]

2. I think based on the earlier stories I read

the issue wasn't with the very youngest - i.e., the 6 months to 2 years old group. It was with the "older" ones of the range. In fact, the OP article repeated this finding -

Friday’s action was the latest twist in the saga of the long-awaited pediatric vaccine. In December, Pfizer and BioNTech announced that the immune response generated by the vaccine in children between 2 and 4 years old was not sufficiently robust. The vaccine did provoke a strong enough response in children 6 months to 2 years old. A third shot was added to the trial to increase the immune response.

Normally they might take years to come up with the proper doses (whether as a single shot or multiple) for certain age groups but because this pandemic has been such a nightmare and health emergency, they haven't had the luxury of time to do this and hoped they could at least ballpark a dosing regime and get it out there while continuing with other dosing trials when possible.

For the Pfizer vaccine, the "normal" single dose for ages 12+ is 30ug (micrograms), with a 2-dose initial series and a 3rd dose as a "booster". For children 5 - 11, it's reduced to 10ug (single dose), as a 2-dose series plus a 3rd dose as a "booster". Those who are immuno-compromised would have a slightly different number of doses needed.

But for the under 5, they are using 3ug and had aimed for a 2-dose initial series for the entire 6 months - 4 range (without need for a booster right away as they needed time to see how long the immune response lasted before deciding that), and that's where the problem lies (the infants/young toddlers were good with it but not the older children because their immune systems were not being triggered with the 3ug), and thus the delay.

So it almost suggests that the 3/4 year olds might either need a 10ug to get their immune systems triggered (and even with that, it could be some kind of different combination too - say 10ug initial with 3ug as a 2nd dose) -OR- what they seem to be suggesting, doing the 3ug as a 3-dose series for the older end of the range vs a 2-dose series that would be the regular course for the infants - young toddlers. I don't think they were ready to go there yet, but probably will need to.

It's possible that the "older" range of that age group might be triggered with 5ug vs 3ug - but again, that requires time and study to see what the effects are while trying not to complicate the whole thing with such a range of doses (I think the idea has generally been to use the minimum dose required that provides the best efficacy while maintaining safety (and limiting side effects).

So it seems their easiest next steps would probably be to try a 3rd dose for the 3 - 4 age group and see if that finally kicks something into gear. The timing of that 3rd dose would obviously extend out the data collection period. But if they get good results from doing that, then they could probably go forward with a generally fixed dosing regime for the whole spectrum of 6 months - adults.