The news of the pushback in vaccine date for the children below 5 years has caused dismay in several quarters. On Friday, the US FDA announced that they would be pushing back the dates for the meeting, which was supposed to be a deciding factor for the vaccines to arrive.
Vaccines For Younger Children – Still Some Distance Away
Moreover, meetings were intended with the vaccine majors, working on the same. However, the vaccine majors have also been told that they would have to conduct further trials for the third dose, and only then would the vaccines be allowed in the markets.
It is to be noted in this regard that the vaccine trial is an important consideration when it comes to releasing it for emergency use in the public. In this case, the age group for the public has to be taken into consideration. Pfizer and BioNTech have said that they expect to get the data on three doses by April. The FDA is of the opinion that the forthcoming data will only help them come to a standpoint.
The FDA is not taking any chances with the vulnerable population. According to the studies and reports by the CDC, 10 million doses of the vaccine may be required in the beginning. Most pediatricians are also waiting for a judgment on this. The meeting was supposed to be held on Feb 15, which now stands canceled.
The FDA has taken a stance not to accept the data based on two doses of the vaccine. According to the recent studies, it was seen that a very minute percentage of the vaccine, as little as 3 mcg, was working on the 6 months – 2 years age group. However, above that, the vaccine dose as ascertained was not performing well.
Therefore, after discussions with several quarters, the FDA has pushed back the date for the vaccine to April, or as may be the case. If the vaccine makers arrive with the vaccine in the market, without proper safety and efficacy reports, there might not be many takers.
So, the officials have announced that it is best to wait until the makers come out with the data on three doses of the vaccine. Moreover, the FDA is of the opinion that before the vaccine can be released for administering, the FDA has to pass the emergency authorization for the same.
When the meeting of the FDA committee is on, the officials review all the data from the clinical trials that occur within the time period. The Advisory Committee that advises the CDC will also sit for a meeting only after the FDA approves the vaccine in April.
The FDA mainly relies on all the data submitted by the vaccine manufacturers. It may contain trials in the laboratories and also other sample population trials. The Advisory Committee on Immunization Practices also needs to vote in favor of the vaccine. That comes after the FDA authorizes the vaccine for emergency use.
The CDC Director has also stated that the ACIP vote is also another mandatory vote that will further decide the course of the vaccine. Once the vote is obtained, it will be easy to give the go-ahead to the manufacturers. However, there will still be many challenges, like shipping the vaccines to each and every corner of the US.
The vaccine makers expect to have the data for the trials in April. The FDA has also said that once they get the data on the three-dose vaccine for kids below 5, they will surely give an emergency use authorization. So, until then, all have to wait and watch what’s on. Once the FDA decides the shipping modalities will be enforced.
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