The head of the Food and Drug Administration was summoned to the White House for a second day running after Britain announced it had approved a COVID-19 vaccine, as Trump officials try to shave days off the time it will take for people to be vaccinated.
President Trump has frequently complained at what he sees as delays in getting vaccinations to the public, and officials stepped up efforts to accelerate that process on Wednesday.
An official familiar with discussions said there was growing irritation at needless delays and at the way the United Kingdom had been able to make a world-leading announcement based on American funding.
“The U.K. is using data from the United States investment,” he said. “So everyone is frustrated that they are able to get to this point ahead of the United States.”
FDA Commissioner Stephen Hahn was called in on Wednesday, after meeting the White House chief of staff on Tuesday, to answer questions about delays.
The pharmaceutical giant Pfizer applied for emergency use authorization for its vaccine (developed with BioNTech) on Nov. 20. But FDA officials are not due to meet until next Wednesday and Thursday to consider issuing approval, a week after Britain approved the same vaccine.
The process would see it likely approved next Friday, with an announcement made on the following Monday — another critical delay.
“Things would start shipping on the Tuesday,” said the official. “So why not make the announcement on the Saturday. Nobody is able to explain these delays that are clearly unnecessary when people are dying.”
In an interview earlier on Wednesday, Hahn characterized his Tuesday meeting as including “robust discussions” around timings. But he added that the FDA was conducting more rigorous scrutiny than elsewhere.
“We are one of the few regulatory agencies in the world, if not the only one, that actually looks at the raw data from clinical trials,” he told CBS This Morning in a Facebook Live interview. “So we’re not going to take a summary from a company and take their conclusions and base our decision on that.”
Trump has made his frustrations clear in the past.
He has complained that pharmaceutical companies delayed the announcement of favorable trial results until after Election Day. He accused them at times of deliberately slowing development in order to reduce his chance of victory.
And he has frequently worried publicly that President-elect Joe Biden will take credit.
On Sunday, he told Fox News: “They will try and say that Biden came up with the vaccines.”
Last week, during the Thanksgiving holiday, he told reporters at the White House: “Don’t let Joe Biden take credit for the vaccines.”
Figures familiar with his thinking say the vaccine and the huge federal effort to accelerate development, known as Operation Warp Speed, are central to what he sees as his legacy and one of the possible foundations of a 2024 election run.
Meanwhile, the White House is talking up its achievements and preparing to get vaccines across the country as soon as approval is granted. Drug and logistics companies have been invited to the White House on Monday for a vaccine summit that officials said would “set the stage” for launching immunization programs.
But for an administration that championed America First, there is frustration that other countries have reached the finish line ahead of Trump and his $12 billion Operation Warp Speed program to rush COVID-19 vaccines to market.
Pfizer was not initially part of Operation Warp Speed, but administration officials point out that it was helped by a $2 billion purchase agreement and that it has followed the same general requirements as competitors that did join the program.
“American taxpayers have put up a tremendous amount of money to be first, and other countries are benefiting off that,” said the official.
But he added that with so much vaccine skepticism among the public, it was right that Hahn and the FDA had adopted the most stringent data review possible.
In a briefing on Wednesday, White House press secretary Kayleigh McEnany played down any suggestions that the FDA chief had been called in for a dressing-down.
She said it was normal for Hahn to have meetings with the White House chief of staff while officials plowed ahead with vaccine production.
“So we want to make sure it comes out as quickly as the data allows it to, and we want 40 million doses by the end of the year, which is a tremendous achievement, not just to have gotten a vaccine in this time, but to have produced 40 million in advance,” she said. “It’s having a businessman as president; the Trump vaccine.”
