[ad_1]
On Tuesday, the Trump administration was quick to justify a decision not to buy millions of backup doses of a Covid-19 vaccine developed by Pfizer, as the vaccine seemed likely to become the first approved for use in the United States. .
Government regulators at the Food and Drug Administration (FDA) announced favorable preliminary findings Tuesday from a review of Pfizer data., following approval for use in the UK and the first post-approval vaccination there.
The Trump administration struck a deal last spring for 100 million doses of Pfizer’s candidate vaccine, but the administration rejected an offer to reserve additional doses, confirmed Scott Gottlieb, a current Pfizer board member and former FDA commissioner. , on Tuesday.
“Pfizer offered an additional allocation from that plan, basically the second quarter allocation, to the US government several times, and as recently as after the interim data came out and we knew this vaccine appeared to be effective.” Gottlieb saying CNBC.
“I think they were betting that more than one vaccine will be licensed and there will be more vaccines on the market, and maybe that could be the reason they didn’t accept that additional 100 million option deal.”
As global demand for its vaccine has exploded following successful trial results and approval in the United Kingdom, New York-based Pfizer cannot guarantee additional doses in the United States before next June, reported the New York Times.
It was unclear to what extent the decision not to purchase more of the Pfizer vaccine could hamper the vaccination effort in the United States.
The news came as the United States was about to exceed 15 million cases of coronavirus, the highest number in the world.
A second vaccine candidate is currently pending emergency FDA approval, and several additional vaccine candidates, some of them easier to handle than the Pfizer vaccine, which must be stored in extremely cold temperatures, are in the stages. final clinical review.
But Donald Trump and officials involved in the vaccine development program rushed Tuesday to avoid the perception that the government had not been first in line to get enough supplies of a vaccine produced by a US-based company. . US-based Pfizer teamed up and its German pharmaceutical partner BioNTech are on track to have the first vaccine approved in the US.
To celebrate the good news about vaccines and promote his role in it, Trump planned to host an event at the White House on Tuesday billed as a “vaccine summit.” It planned to release an executive order to prioritize vaccine shipments to “Americans over other nations,” but like many headline-grabbing orders issued by Trump, the decree did not appear to have impact or enforceability, the officials said. analysts.
When asked on ABC’s Good Morning America Tuesday how the order would work, the official in charge of the government’s vaccine development program, Operation Warp Speed, Moncef Slaoui, said: “Frankly, I don’t know.”
Health officials appointed by President-elect Joe Biden, who will lead the vaccine implementation effort after taking office next month, were not invited to the White House event, underscoring the risks of a lack of continuity. in effort.
And executives from two drug companies, Pfizer and Moderna, whose own vaccine candidate is also subject to FDA approval, were invited to the White House by Trump but declined, Stat News reported.
Slaoui defended the administration’s decision not to buy more doses of the Pfizer vaccine, in his appearance Tuesday on ABC, saying they were looking at several different vaccines over the summer when it had the option to block additional doses of the Pfizer vaccine.
“No one would reasonably buy more of any of those vaccines because we didn’t know which one would work and which one would be better than the other,” Slaoui said. Before taking his current position, Slaoui resigned from Moderna’s board.
The United States government has also contracted 100 million doses of the Moderna vaccine. Both vaccines require two doses per patient, although a preliminary report on the Pfizer vaccine released Tuesday by the FDA found some protection after just one dose.
The report, which found that “no specific security issues were identified that would prevent the issuance” of an emergency use authorization, accelerated the path to approval. “The FDA has determined that [Pfizer] it has provided adequate information to guarantee the quality and consistency of the vaccine for the authorization of the product under an EUA, “said the report.
A spokeswoman for the Department of Health and Human Services told the Times that, in addition to Pfizer and Moderna, the government had signed dose contracts for other candidate vaccines that had not yet reached the stage of seeking regulatory approval.
“We are confident that we will have 100 million doses of the Pfizer vaccine as agreed in our contract, and beyond that, we have another five candidate vaccines, including 100 million doses on the way from Moderna,” he said.
[ad_2]
