The Trump administration on Tuesday scrambled to justify a decision not to buy millions of backup doses of a Covid-19 vaccine developed by Pfizer as the vaccine appeared likely to become the first approved for use in the United States.
Government regulators with the Food and Drug Administration (FDA) announced favorable preliminary findings on Tuesday from a review of Pfizer data, following approval for use in the UK and the first post-approval vaccination there.
The Trump administration last spring made a deal for 100m doses of the Pfizer vaccine candidate, but the administration turned down an offer to reserve additional doses, Scott Gottlieb, a current Pfizer board member and former FDA commissioner, confirmed on Tuesday.
“Pfizer did offer an additional allotment coming out of that plan, basically the second-quarter allotment, to the US government multiple times – and as recently as after the interim data came out and we knew this vaccine looked to be effective,” Gottlieb told CNBC.
“I think they were betting that more than one vaccine is going to get authorized and there will be more vaccines on the market, and that perhaps could be why they didn’t take up that additional 100m option agreement.”
With global demand for its vaccine soaring following successful trial results and approval in the United Kingdom, New York-based Pfizer cannot guarantee the United States additional doses before next June, the New York Times reported.
The extent to which the decision not to acquire more of the Pfizer vaccine could impede the vaccination effort in the United States was unclear.
The news came as the US was on the verge of surpassing 15 million coronavirus cases, the highest number in the world.
A second vaccine candidate is currently up for emergency approval from the FDA, and multiple additional vaccine candidates – some of them easier to manage than the Pfizer vaccine, which must 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 scrambled on Tuesday to head off the perception that the government had failed to get first in line for sufficient supplies of a vaccine produced by an American-based company. US-based Pfizer partnered and its German pharmaceutical partner, BioNTech, are on track to have the first vaccine approved in the US.
To celebrate the good vaccine news and tout his role in it, Trump planned to host an event at the White House on Tuesday billed as a “vaccine summit”. He planned to unveil an executive order to prioritize vaccine shipments to “Americans before other nations,” but as with many headline-grabbing orders issued by Trump the decree did not appear to be impactful or enforceable, analysts said.
Asked on ABC’s Good Morning America on 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 named 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, underscoring the risks of a lack of continuity in the effort.
And executives from 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 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 during the summer when it had the option to lock in additional Pfizer vaccine doses.
“No one reasonably would buy more from any one of those vaccines because we didn’t know which one would work and which one would be better than the other,” said Slaoui. Before taking his current post, Slaoui resigned from the Moderna board.
The US government has also contracted for 100m doses of the Moderna vaccine. Both vaccines require two doses per patient, although a preliminary report on the Pfizer vaccine issued on Tuesday by the FDA found some protection after just one dose.
The report, which found “no specific safety concerns identified that would preclude issuance” of an emergency use authorization, accelerated the path to approval. “FDA has determined that [Pfizer] has provided adequate information to ensure the vaccine’s quality and consistency for authorization of the product under an EUA,” the report said.
A spokeswoman for the Department of Health and Human Services told the Times that in addition to Pfizer and Moderna, the government had signed contracts for doses for other vaccine candidates that have not yet reached the stage of seeking regulatory approval.
“We are confident that we will have 100 million doses of Pfizer’s vaccine as agreed to in our contract, and beyond that, we have five other vaccine candidates, including 100 million doses on the way from Moderna,” she said.
Source: US Politics - theguardian.com
