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If Pfizer's vaccine gets an emergency use authorization, it could reach sites designated by states within a day.
The chief adviser to the Trump administration’s vaccine development program said Sunday that vaccines for the coronavirus disease 2019 (COVID-19) would begin shipping within 24 hours of an emergency use authorization (EUA) from FDA, and people could receive vaccinations shortly after that.
“We are ready to start shipping vaccines within 24 hours from approval. Ship them to the sites that each state that are located — a quantity of vaccine that's proportional to their population tells us where to deliver the vaccine,” Moncef Slaoui, PhD, said on ABC's "This Week."
“We'll have the vaccines there the next day after approval, and hopefully people will start to be immunized, I would say within 48 hours from the approval,” said Slaoui, who is the former head of GlaxoSmithKline’s vaccine section. He appeared on the weekly news program after Friday’s news that Pfizer and BioNTech filed the first application with FDA for emergency use for a COVID-19 vaccine.
The news followed the companies’ statement that the vaccine had shown 95% efficacy beginning 28 days after the first of 2 doses. The full data have not been published. FDA has scheduled a December 10, 2020, meeting of its Vaccines and Related Biological Products Advisory Committee to discuss the EUA.
Slaoui also pushed back against statements from President Trump that he is unhappy with Pfizer and believes the company purposely delayed announcing the positive results until after Election Day on November 3.
"I do think that asking for 60 days follow-up after completion of immunization to ensure that we understand the short term, and the predictable, long-term safety of the vaccine is an appropriate decision and I understand that that's what drove the timelines of Pfizer so as far as I know. I don't think any specific action has taken place to delay the vaccine," Slaoui said.
Under an EUA, a treatment or vaccine an be used while FDA continues to gather evidence that would be part of a full approval process, if it can be demonstrated that the benefits of the EUA outweigh the risks. An EUA may have a time limit and come up for renewal, and the company granted the authorization is given conditions for receiving a full approval.
Regeneron EUA granted. FDA on Saturday granted an EUA for the combination monoclonal antibody treatment that Trump received after being diagnosed with COVID-19, which will give physicians an additional treatment option as cases surge to record levels ahead of the Thanksgiving holiday.
The treatment, made by Regeneron, combines casirivimab and imdevimab, which must be administered together by intravenous (IV) infusion and can only be given to certain patients. FDA limited the EUA to the treatment of patients at least 12 years old who have mild to moderate symptoms but are at high risk of progressing to severe COVID-19. This could include patients age 65 or older or those with comorbidities or chronic medical conditions. The idea is to treat those at greatest risk before the disease attacks organ systems and interferes with breathing.
Notably, the antibody combination is not authorized for patients outside the hospital setting or patients already on oxygen or a ventilator, as FDA said that monoclonal antibodies may produce worse outcomes in these patients.
A similar antibody treatment from Eli Lilly received an EUA earlier this month.