Trump Says Vaccine Will Be Ready In A Few Weeks; Pfizer says some patients show side effects

President Donald Trump reiterated his belief that a coronavirus vaccine can arrive before Election Day, even as top administration health officials have rejected that schedule, and vaccine manufacturers have vowed to wait. safety and efficacy data.

In an interview with Fox & Friends, Trump said that a vaccine could be ready for distribution in as little as four to eight weeks, a very condensed schedule for approval and distribution that many experts have questioned.

“We are going to have a vaccine in a matter of weeks, it could be four weeks, it could be eight weeks … it will be before the elections, it could be … we will start delivering it immediately after receiving it,” he said. said.

The aggressive schedule has intensified the debate around the deployment of a possible cure for COVID-19, which is seen as crucial to restarting public life and ending the threat of shutdowns.

While he doesn’t reference a specific date or timeline, Trump’s own health officials, including U.S. Food and Drug Commissioner Stephen Hahn, have reiterated their commitment to safety when approving any drug. Anthony Fauci, director of the National Institute of Allergies and Infectious Diseases, said an election day vaccine was unlikely, but at least theoretically possible.

Since the FDA exists under the executive branch and therefore under the White House, much like the United States Department of Health and Human Services (HHS), the White House may lobby, and there are provisions giving HHS Sec. Alex Azar the authority to push for an emergency clearance.

But in an article published Tuesday in the New England Journal of Medicine, officials at Operation Warp Speed, including director Moncef Slaoui, indicated a January 2021 focus for distribution and approval of the vaccine.

Still, complications in human trials can emerge as an obstacle to the rapid deployment of any inoculation, an expectation in the clinical trial process. On Tuesday, Pfizer (PFE) said some of its test subjects showed mild to moderate sequelae to the company’s experimental coronavirus vaccine or placebo. The data showed that fatigue was the most common sentiment, executives said in a call to investors.

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The recent setback with AstraZeneca (AZN) clinical trials of the Oxford University vaccine is another indicator of a possible delay: while UK Phase 3 trials have resumed, the US remains on hold. The National Institutes of Health is concerned about the mysterious illness that suspended the trial in the UK and says the company has offered no useful information. The company has said it believes a vaccine can still be approved by the end of the year.

Moderna (MRNA), a key pioneer heavily funded by federal research dollars, has also pledged at the end of the year. Meanwhile, collaborators Pfizer and BioNTech (BNTX) have said they are on track to have at least results by the end of October, but not in time for an FDA meeting on October 22 that will discuss approval and distribution details. of vaccines.

But Pfizer also said the FDA has indicated it will weigh an emergency use authorization based on a subset of the trial population. Although there are more than 30,000 trials for Phase 3, and Pfizer has said it will expand to 44,000, the FDA only requires safety data for 6,000, 3,000 vaccinated and 3,000 placebo, executives said on the call.

Trump also referenced Johnson & Johnson (JNJ), which is using technology similar to AstraZeneca, and has not even entered late-stage testing for its candidate, although the company has said they will do so this month. Following the AstraZeneca scare, some participants in a phase 2 study in Spain have withdrawn.

The story continues