“This can be used in conjunction with the vaccine. And it’s not an alternative to vaccination. We still have to try to get more people vaccinated,” Dr. Scott Gottlieb, former commissioner of the US Food and Drug Administration, told CNN on Friday.
Gottlieb acknowledged that the antiviral medicine could be effective for those who choose not to get vaccinated as well as those who catch the virus while fully vaccinated.
“This is the most impactful result that I remember seeing of an orally available drug in the treatment of a respiratory pathogen, perhaps ever,” Gottlieb told CNN’s Anderson Cooper. “I think getting an oral pill that can inhibit viral replication — that can inhibit this virus — is going to be a real game-changer.”
Merck said Friday it will seek FDA emergency use authorization for its molnupiravir medication “as soon as possible.” If permitted, it would become the first oral medicine that fights viral infection for Covid-19.
“If approved, I think the right way to think about this is this is a potential additional tool in our toolbox to protect people from the worst outcomes of Covid,” White House Covid-19 Response Coordinator Jeff Zients said Friday.
Zients echoed Gottlieb’s stance on vaccination, underscoring inoculation remains “far and away our best tool against Covid-19” because the shots can prevent people from getting infected in the first place.
“And we want to prevent infections, not just wait to treat them once they happen,” Zients said.
Meanwhile, Louisiana reported Friday that a child at or under the age of four died from Covid-19. It was the state’s 17th pediatric death from the virus.
“We owe it to ourselves, our children and everyone around us to take advantage of the best protection we have, and that is the vaccine and wearing a mask,” Louisiana State Health Officer Dr. Joseph Kanter said.
More booster talks to come
Americans who received the Moderna or Johnson & Johnson vaccines can expect to hear next steps for booster shots this month.
The FDA will meet with its Vaccines and Related Biological Products Advisory Committee on October 14 and 15 to discuss those boosters for those vaccines, which have only been authorized for emergency use in those 18 and older. The committee will also consider data on “mix and match” use of boosters, the agency said Friday.
Only Pfizer’s Covid-19 two-dose vaccine has been fully approved by the FDA for people 12 and older. Pfizer’s booster shot is authorized for emergency use in people 65 and older, people at high risk of severe disease and people whose jobs put them at risk of infection.
More than 4.03 million people have received an additional dose of Covid-19 vaccine — or booster — since August 13.
The FDA vaccine committee is also slated to discuss Pfizer’s Covid-19 vaccine for children ages 5 to 11 on October 26. Pfizer has started submitting data about this age group to the agency but has not yet formally requested emergency use authorization.
The committee of independent advisers typically discusses and makes recommendations to the FDA on vaccine authorizations and approvals. Then, the agency makes the final decision.
Vaccine mandates continue coming into play
On Friday, American Airlines told its US workers that they must follow the Biden administration’s requirement to be vaccinated against Covid-19. The airline noted that its business with the federal government means it will be covered under the mandate but fell short of saying when the requirement takes effect.
Religious and disability-related exemptions will be available, but there will be no “provision of a regular testing alternative,” the airline said.
“While we are still working through the details of the federal requirements, it is clear that team members who choose to remain unvaccinated will not be able to work at American Airlines,” according to a memo CNN obtained from the airline management sent to employees.
“This is not a mandate as non-employed spouses and domestic partners can choose to select a health plan outside of Ochsner Health offerings. As with our employee vaccination policy, spouses and domestic partners with medical and religious objections will be able to file exemption requests,” Ochsner Health President and CEO Warner Thomas said in a statement this week.
CNN’s Naomi Thomas, Virginia Langmaid, Jamie Gumbrecht, Gregory Wallace, Rebekah Riess, Lauren Mascarenhas contributed to this report.
Source : cnn