CNN confirmed with the FDA on Wednesday that if a manufacturer requests a change in its emergency use authorization, the manufacturer must submit data to the FDA that supports the requested change.
“If it moves, it will not be the FDA that moves it. They are bound by legal activities that determine how drugs are approved in the country, so it is not surprising to hear them say that they are strongly preferred to stick to what we know works, “Benkeser said, adding that any changes are likely to be submitted to the FDA for consideration and then the agency will review the data that supports such changes.
“They will want to see correlate data,” Benkeser said. “And if we can determine and validate a correlate, I think they will consider alternative dosing schedules next year, as well as new vaccines.”
‘Suggest changes … is premature’
Health officials are speculating about the possibility of expanding the vaccine supply by giving people a single dose instead of two doses, or perhaps by reducing doses by half. British officials have caused a stir by saying they would consider such changes.
In Britain, medical officials decided last week to extend the 21-day period between the first and second doses of the Pfizer / BioNTech Covid-19 vaccine to extend the vaccine supply.
Pfizer said it did not have data to show that only a single dose of the vaccine would provide protection against the disease after more than 21 days.
“Pfizer and BioNTech’s Phase 3 study for the Covid-19 vaccine is designed to evaluate the safety and efficacy of the vaccine according to a two-dose schedule, separated by 21 days,” Pfizer said in a statement on Thursday. “There are no data to show that protection is maintained after the first dose after 21 days.”
“Such changes currently pose a risk of undermining vaccine effectiveness and undermining public confidence needed for successful vaccine uptake. As always, our approach to this pandemic should be based on science, leadership, funding, collaboration. and collaboration, “Dr. Barbara D. Alexander, president of IDSA, and dr. Rajesh Gandhi, chairman of the HIV Medicine Association, wrote in the joint statement.
“This is a unique moment”
The overall development of Covid-19 vaccines – including dosing schedules and the process of getting them into the arms – was unprecedented, the Benoryer of Emory said.
“In many ways, it’s a unique moment,” Benkeser said. In the past “there were outbreaks and science had to react very quickly in the manufacture of a vaccine. Ebola, for example, was one where we found a vaccine in the field that seemed to be very effective – but the outbreak of Ebola was never on Covid’s scale. ‘It took years before an Ebola vaccine was approved.
It is now being criticized that the Covid-19 vaccines are being administered to people in the United States as slow and awkward, but the rollout is likely to gain momentum in the coming weeks, said Dr. Anthony Fauci said Tuesday.
“We have to be really careful, Randi, that we will not come to a conclusion based on a very short period of time, because we have just started,” Fauci said.
“The government and the local people, including the governors and the mayors and others, have just started in the last few weeks in December, right in the middle of the holiday season,” Fauci said. “I think we have to wait until the first and second week in January to see if we can catch up.”