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Can Trump Really Speed Approval of Covid Treatments?

The Bioshield Act, along with the laws that later modified it, was not intended as a carte blanche. For instance, an E.U.A. can only be granted during a declared public health or national security emergency, and is supposed to be used only for products that have no adequate, approved or available alternatives. But the F.D.A. was granted wide discretion to decide whether a product ought to be made available to the public. By law, the agency can grant E.U.A.s to products that “may be effective,” whose “known and potential benefits” outweigh “the known and potential risks.” It is up to the agency, however, to determine what those criteria mean.

“It was deliberately a quite flexible kind of standard,” said Dr. Jesse Goodman, the director of the Center on Medical Product Access, Safety and Stewardship at Georgetown, and the F.D.A.’s chief scientist from 2009 to 2014. E.U.A.s are intended to be evaluated on a case-by-case basis; the F.D.A. might tolerate more risk for a drug designed to treat a disease with a high mortality rate, such as Ebola, than for a vaccine that would be given to healthy people to stop a disease like Covid-19, Mr. Goodman said.

But, he added, E.U.A.s were not meant as a substitute for traditional approvals: “The intent originally was that ultimately you should be collecting data and moving these products toward approval,” even after the emergency authorization was granted.

However, it can be difficult to fully enroll a product in clinical trials after it has received an E.U.A., Dr. Goodman said, because clinical trials typically impose more stringent requirements on patients than an E.U.A. would. “Now we have tens of thousands of people getting convalescent plasma” — a Covid-19 treatment that was granted an E.U.A. in August — “and we still don’t know whether it works,” he said.

Another potential hazard of emergency authorization became apparent not long after the Bioshield Act was signed into law, when the F.D.A. granted its first E.U.A., at the request of the Defense Department, for the use of an anthrax vaccine, in 2005. That authorization suggested to some people, including Chris Shays, then a Republican congressman from Connecticut, that the E.U.A. process provided an avenue for political interference. The apparent urgency “appears to be the product of preventable legal and regulatory failures,” Mr. Shays wrote in a letter to the Secretary of Health and Human Services, “rather than any validated external threat.”

The actions of the Trump administration during the Covid pandemic have renewed these concerns. In May, Rick Bright, the former head of the Biomedical Advanced Research and Development Authority, alleged in a whistle-blower complaint that he had arranged an E.U.A. request for hydroxychloroquine and chloroquine as a “compromise position” to head off pressure by administration officials to make the drugs available under a less-restrictive protocol known as “expanded access.”

In late September, Mr. Trump said that he was considering blocking the F.D.A.’s vaccine E.U.A. guidelines, which made it unlikely that a vaccine would be authorized before the

Trump has personally pressured drug company CEOs repeatedly to speed vaccine

A likely contagious President Donald Trump returned to the White House Monday evening, whipped off his mask and filmed a video, heavy on bluster and short on facts, that proclaimed: “The vaccines are coming momentarily.”



Donald Trump wearing a suit and tie: WASHINGTON, DC - SEPTEMBER 30: U.S. President Donald Trump speaks to reporters on his way to Marine One on the South Lawn of the White House on September 30, 2020 in Washington, DC. President Trump is traveling to Minnesota for a fundraising event and a campaign rally. (Photo by Drew Angerer/Getty Images)


© Drew Angerer/Getty Images
WASHINGTON, DC – SEPTEMBER 30: U.S. President Donald Trump speaks to reporters on his way to Marine One on the South Lawn of the White House on September 30, 2020 in Washington, DC. President Trump is traveling to Minnesota for a fundraising event and a campaign rally. (Photo by Drew Angerer/Getty Images)

Trump, who tested positive for coronavirus last week and is now receiving medical care at the White House, has remained laser-focused on vaccine development even as he has been dismissive of mask-wearing and social distancing — protections health experts say are critical to stopping the spread of the coronavirus.

Even before his diagnosis, the President had taken to calling drug companies to check on their vaccine trials, asking how much longer they’ll take and ginning up the pressure around his desire for a vaccine before Election Day.

In his conversations with major drug-makers working on coronavirus vaccines, Trump has been explicit in telling the companies’ CEOs that he’d like to see a vaccine move quicker than some of his health advisers say is reasonable, according to a person familiar with the conversations. He has asked whether they believe they can speed up their timelines and has suggested he is concerned that the FDA’s regulatory process could slow down progress.

In a tweet Tuesday night, Trump slammed new rules from the agency that would make it nearly impossible for a vaccine to be approved ahead of the election, calling them a “political hit job.”

“New FDA Rules make it more difficult for them to speed up vaccines for approval before Election Day. Just another political hit job!” he wrote in the tweet, which he aimed at FDA commissioner Dr. Stephen Hahn.

Trump’s repeated calls — especially to Pfizer, whose progress the President sounds most hopeful about recently — are likely to continue through a presidential election that may turn on how voters perceive his handling of the public health crisis.

Meantime, experts worry what Trump’s undivided attention means for the fate of the vaccine. With so much obvious political pressure coming to bear, people may fear that the vaccines aren’t safe for widespread use. Beyond that, they may lose trust in federal regulators and, possibly, in research science.

The political climate surrounding a potential coronavirus vaccine already has scientists cringing.

“There just seems to be this huge pressure from an administration that has been very effective at getting everything wrong,” said Dr. Esther Choo, an emergency medicine physician and professor at Oregon Health & Science University. “So, it’s like, how can this go well?”

White House spokeswoman Sarah Matthews dismissed those concerns.

“This President understands that this vaccine cannot get bogged down in government bureaucracy,” Matthews said. “The Trump administration is focused on delivering a safe, effective vaccine to

EU agency starts ‘rolling review’ to speed OK for vaccine

LONDON (AP) — The European Medicines Agency has started a “rolling review” process for the COVID-19 vaccine being developed by Oxford University and AstraZeneca, a move it hopes will speed any eventual approval.

In a statement Thursday, the EU regulator said instead of waiting for all of the required vaccine data to be submitted before beginning its assessment, the EMA has begun analyzing the preliminary information from scientists on the Oxford vaccine.

That data suggests the vaccine “triggers the production of antibodies and T-Cells,” referring to immune system cells that target the virus. The agency said it was waiting for data from ongoing late-stage tests of the vaccine involving thousands of people, which it hopes will be shared in the coming weeks and months.

“The rolling review will continue until enough evidence is available to support a formal marketing authorization,” the EMA said.


The agency said it could not estimate how long this process might take, but that it would be quicker than the normal evaluation procedure. A similar process was used to issue an approval for remdesivir, one of the only licensed drugs to treat COVID-19. That approval was issued in just over one month while the standard process can take nearly seven months.

Oxford’s vaccine is designed to reduce disease and transmission. It uses a harmless virus — a chimpanzee cold virus, engineered so it can’t spread — to carry the coronavirus’ spike protein into the body, which should trigger an immune response. The tests are looking at both one-shot and two-shot vaccine doses.

Initial information suggested the vaccine provoked a strong immune response in volunteers and is safe, but longer-term data is needed.

AstraZeneca, which is manufacturing the vaccine, has signed numerous private deals to provide millions of doses to countries including Britain, the U.S., France, Germany and Canada. The first deliveries are expected this fall, before being licensed.

Last month, Britain’s trial of the Oxford vaccine was paused for several days after a U.K. woman in the trial reported severe neurological symptoms. Although the study has since restarted, a similar trial in the U.S. is awaiting further examination from the Food and Drug Administration before the research can continue.

Several other vaccines are undergoing late-stage testing in China, Russia, the U.S., Brazil and other hard-hit countries.

In August, Russia became the first country in the world to license its Sputnik V COVID-19 vaccine. The shot is still being tested in advanced trials but has been offered to key workers, several high-profile politicians and one of President Vladimir Putin’s daughters.

On Thursday, authorities in Belarus began testing Sputnik V in 100 volunteers in Minsk, the capital.

Several Chinese vaccine makers, including Sinovac Biotech Ltd, have also injected thousands of their employees and family members with their experimental shots, under an emergency use provision. The Chinese military has also approved the use of a vaccine it developed with CanSino Biologics Inc., a biopharmaceutical company, in military personnel.

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Follow AP’s pandemic coverage at http://apnews.com/VirusOutbreak and https://apnews.com/UnderstandingtheOutbreak

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