(Trends Wide) — A highly anticipated announcement Monday from the companies Pfizer and BioNTech revealed that their lower-dose covid-19 vaccine was found to be safe and elicited a “robust” antibody response in children ages 5 to 11, according to data from a trial from phase 2/3.
Many parents are now waiting for the time when their young children can sign up for the COVID-19 vaccine, but there are several steps that need to be taken first.
1. Pfizer has to apply to the FDA for approval of the vaccine for this age group
Pfizer and BioNTech have yet to apply to the US Food and Drug Administration (FDA) for emergency use authorization (EUA) of their covid-19 vaccine to include children from 5 to 11 years old.
“The company has to submit a request to modify its emergency use authorization to include the additional population,” an FDA spokesperson told Trends Wide in an email Monday.
The Pfizer and BioNtech phase 2/3 trial included 2,268 children between the ages of 5 and 11 and consisted of a two-dose regimen of the vaccine 21 days apart. The trial used a 10-microgram dose of the vaccine, smaller than the 30-microgram dose currently used in people 12 years of age and older.
Pfizer said Monday that its application to the FDA would be submitted soon.
Dr. Scott Gottlieb, a former FDA commissioner and a member of Pfizer’s board of directors, commented on CNBC’s Squawk Box show Monday morning that Pfizer could present it to the FDA “very quickly.”
“The data came in a little earlier than some expected, and depending on how long the FDA takes to review the application, be it a four-week or six-week review, a vaccine could be available for children as soon as likely. By the end of October, it might be a bit delayed until November, “Gottlieb said.
2. The FDA must modify the authorization for emergency use of the vaccine to include the very young.
In August, the FDA granted full approval to Pfizer / BioNTech’s covid-19 vaccine for people 16 years of age and older, but it remains under the US for children 12 to 15 years of age.
Therefore, the EUA would have to be expanded to include younger ages.
“When FDA receives a complete US application or approval, the agency will carefully, thoroughly, and independently examine the data to assess benefits and risks, and will be prepared to complete its review as quickly as possible, likely in a matter of weeks, not months, “FDA Acting Commissioner Dr. Janet Woodcock and Dr. Peter Marks, director of the FDA’s Center for the Evaluation and Research of Biologics, said in a statement earlier this month. FDA.
“However, the agency’s ability to review these requests quickly will depend in part on the quality and timeliness of the manufacturers’ requests,” Woodcock and Marks noted. “Like all the vaccine decisions we have made during this pandemic, our evaluation of the data on the use of COVID-19 vaccines in children will leave out nothing.”
Members of the FDA’s Vaccines and Related Biologics Advisory Committee are likely to meet to discuss the Pfizer and BioNTech data and to decide whether to recommend that the EUA be amended to include children ages 5 to 11.
“Once we know when that meeting will occur, that will give us a good idea of when we might see approval,” said Dr. Evan Anderson, a Children’s Healthcare of Atlanta physician and professor of Pediatrics and Medicine at the Emory University, during a call with reporters Monday.
“That meeting of advisers will have to happen then,” he said. “Then the FDA would have to agree or disagree with its outside advisory group on the possible approval.”
3. CDC should have a say on the vaccine for children ages 5 to 11
Once the FDA makes its decision on the authorization of the vaccine for young children ages 5 to 11, the Advisory Committee on Immunization Practices of the Centers for Disease Control and Prevention (CDC for its acronym in English). The US will next meet to discuss new clinical recommendations on the vaccine.
“Normally, that has happened within a couple of days after FDA approval, and I think it’s likely to happen again in this case, and once that is in place, the vaccines will be able to be used,” Anderson said. .
Meanwhile, Pfizer said in a statement emailed to Trends Wide on Monday that it continues to focus on providing the vaccine for those currently eligible to receive the injection.
“Pfizer and BioNTech continue to supply the vaccine, under their existing supply agreement with the United States government, which continues through April 2022. Following the introduction of the booster doses in the United States under the EUA, and the approval and / or the EUA in new ages, the existing supply agreements that Pfizer and BioNTech have with governments around the world and international health organizations will not be affected, “the statement said.
“Companies will continue to deliver on their promise to supply 2 billion doses to low- and middle-income countries in 2021 and 2022, 1 billion every year,” he added.
4. Once the CDC and FDA give their consent, the vaccine rollout for younger children could begin.
The vaccine that Pfizer tested in children is the same as the one used in adults, but with a smaller dose: 10 micrograms, instead of 30 micrograms.
Although many adults were vaccinated in nursing homes or mass vaccination centers at first, the deployment was different when people between the ages of 12 and 15 were vaccinated. For them, the focus was on pharmacies and doctors’ offices, and this is likely to be the case for younger children as well.
When the vaccine was licensed for children ages 12 to 15 in May, state health officials said it was “better than expected” and appointments were quickly booked. However, vaccinations among teens did not keep pace, and cases among children have risen in recent weeks.
“Certainly, I think there is high hope that we will see acceptance among our 5- to 11-year-olds as long as the vaccine is available, but I think similar to what we are seeing in adolescents and adults, there will be some doubts that will be a major problem for the potential impact of the approval of such a vaccine, “Anderson said.
This is also not expected to be the last group to go through the authorization process.
Results are still being obtained for even younger children. Pfizer said Monday that it expects trial data for children as young as 6 months “as early as the fourth quarter of this year.”
The Moderna and Johnson & Johnson vaccines are licensed for people 18 years of age and older, but are also being studied at younger ages.
Trends Wide’s Naomi Thomas contributed to this report.