The Trump administration on Tuesday rebuked Pfizer for justifying its decision not to buy millions of backup doses of the Covid-19 vaccine, as the vaccine is expected to be the first to be approved for use in the United States.
Government regulators with the Food and Drug Administration (FDA) on Tuesday released favorable preliminary findings from a review of Pfizer data., The first vaccination after approval for use in the UK and after approval there.
The Trump administration struck a deal last spring for a 100-meter dose of the Pfizer vaccine candidate, but the administration turned down an offer to reserve an additional dose, Scott Gottlieb, a current Pfizer board member and former FDA commissioner, confirmed Tuesday.
“Pfizer offered an additional allocation coming out of that plan, basically a second-quarter allocation, to the U.S. government several times – and after the interim data came out and we knew the vaccine seemed to be effective,” he said. Gottlieb Said CNBC
“I think they were betting that more than one vaccine was going to be authorized and there would be more vaccines on the market, and maybe that’s why they didn’t contract that extra 100 meter option.”
New York-based Pfizer will not be able to guarantee additional doses to the United States before next June in the global demand for its vaccine, following successful trial results and approval from the United Kingdom, the New York Times reported.
It was unclear whether the decision not to increasingly vaccinate Pfizer in the United States could hamper vaccination efforts.
The news is on the verge of surpassing America’s 15 million coronavirus cases, the highest number in the world.
The second vaccine candidate is currently for emergency approval from the FDA, and many additional vaccine candidates – some of them easier to administer than the Pfizer vaccine, which should be stored at extremely cold temperatures – are in the final stages of clinical review.
But, Donald Trump and officials involved in the vaccine development program on Tuesday were sticking to the assumption that the government has failed in the first place in line for an adequate supply of vaccines produced by the American-based company. U.S. Pfizer is based in partnership with its German pharmaceutical partner, Bioentech, U.S. Is on the way to approving the first vaccine.
To celebrate the good vaccine news and consider its role in it, Trump planned to host an event at the White House on Tuesday, dubbed the “Vaccine Summit.” Analysts say they plan to unveil an executive order prioritizing vaccine shipments for “Americans before other countries,” but many of the key headlines issued by Trump did not appear to be effective or enforceable.
Asked on ABC’s Good Morning America on Tuesday how the order would work, Monsef Sloi, in charge of the government’s vaccine development program, Operation Operation Rap Speed, said: “To be honest, I don’t know.”
Health officials nominated by President-elect Joe Biden, who will lead the vaccine rollout effort after taking office next month, were not invited to the White House event, indicating risks of a lack of consistency in efforts.
Officials at two drug companies, Pfizer and Moderna – whose own vaccine candidate is also up for approval from the FDA – were invited to the White House by Trump, but refused, according to a State News report.
Slooy defended the administration’s decision not to buy more doses of the FC vaccine, in its appearance on ABC on Tuesday, saying they were looking at different vaccines during the summer when they had the option to lock additional Pfizer vaccine doses.
“None of them will reasonably buy more than one vaccine, because we don’t know which one will work and which one will be better than the other,” Sloe said. Prior to taking office, Sloan resigned from the board of Moderna.
The US government has also agreed to a 100th dose of the Moderna vaccine. Both vaccines require two doses per person, although a preliminary report on the Pfizer vaccine released by the FDA on Tuesday found some protection after just one dose.
The report, which found no “specific security concerns that would prevent identification” of an emergency use authorization, accelerated the path to approval. “The FDA has decided that [Pfizer] Adequate information has been provided to ensure the quality and compatibility of vaccines for product authorization under the EU, ”the report said.
A spokesman for the Department of Health and Human Services told the Times that in addition to Pfizer and Moder, the government had signed dosage agreements for other vaccine candidates who had not yet reached the stage of obtaining regulatory approval.
“We are confident that we will have 100 million doses of the Pfizer vaccine as agreed in our agreement, and in addition, we have five other vaccine candidates, including 100 million doses from Modern.”
