FDA out with new guides on vaccines

WASHINGTON — The Food and Drug Administration released new guidelines Tuesday for coronavirus vaccine developers — a step that had been held up for two weeks by top White House officials. The guidelines make it highly unlikely that a vaccine can be authorized by Election Day.

The move, which was cleared by the White House’s Office of Management and Budget, appeared to be an abrupt reversal a day after White House officials, including Mark Meadows, the chief of staff, blocked the guidelines. Top FDA officials learned late Tuesday that the new guidelines had been cleared.

In the new guidelines posted on its website, the FDA said vaccine makers should follow trial participants for at least two months to rule out any major side effects before seeking emergency approval. That standard had been a sticking point between the FDA and White House officials, who said it could unreasonably delay the availability of covid-19 vaccines.

On Tuesday evening, President Donald Trump acknowledged in a tweet that the new guidelines would make vaccine authorization before Nov. 3 unlikely. “Just another political hit job!” he said, tagging FDA Commissioner Stephen Hahn.

Trump said in a video Monday that vaccines

would be “momentarily.”

Former FDA officials have warned that public perception that a vaccine was being rushed out for political reasons could derail efforts to vaccinate millions of Americans.

A senior administration official said Monday that the White House had blocked the FDA’s plans to formally publish the safety guidelines based on the two-month data requirement, arguing that there was “no clinical or medical reason” for it.

But on Tuesday, the FDA posted the guidance on its website, making clear that regulators plan to impose the safety standards for any vaccine seeking an expedited path to market.

Hahn said in a statement that he hoped the guidelines would help “the public understand our science-based decision-making process that assures vaccine quality, safety and efficacy.”

The requirements are aimed at companies seeking rapid approval through the FDA’s emergency authorization pathway. That accelerated process, reserved for health emergencies, allows medical products onto the market based on a lower bar than traditional FDA approval. But the FDA has made clear that only vaccines that are shown to be safe and effective will be authorized for treatment of the coronavirus.

Former FDA acting commissioner Dr. Stephen Ostroff said the requirements seem reasonable given that the agency is in largely “uncharted territory” in terms of considering emergency use of a vaccine. The agency has previously cleared only one vaccine through the method — a decades-old shot that was authorized to prevent anthrax poisoning in 2005.

“There really is no margin for error here,” Ostroff said. “Even when you’re talking about limited use of a vaccine, there has to be some level of assurance that there isn’t a risk here that would far outweigh the benefit.”

The FDA chose the twomonth timeframe because it’s not “too aggressive” nor “too conservative,” Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said Tuesday at the John Hopkins University and University of Washington Vaccine Symposium.

The window “likely assures no Covid vaccine [emergency authorization] consideration is possible until around November 24-25 for Pfizer/Moderna at the earliest,” Steven Seedhouse, a Raymond James analyst, said in a note to clients Tuesday.

Initial doses of vaccines for emergency use would likely be reserved for medical workers and people with health conditions that make them particularly vulnerable to the coronavirus. Full FDA approval for the general population will require significantly more data and is not expected until mid-2021.

VARIABLES REMAIN

The White House attempt to block the guidance followed a string of instances in which the Trump administration has undercut its own medical experts working to combat the pandemic. The FDA’s Hahn has been attempting to shore up public confidence in the vaccine review process for weeks, vowing that career scientists, not politicians, will decide if the shots are safe and effective.

Pfizer CEO Albert Bourla has stoked excitement by saying that he expects data on whether the company’s vaccine works to be ready in late October. But a number of variables would still have to align for the company to submit, and the FDA to review and green light, a vaccine application before Nov. 3.

In a series of tweets, Bourla said the drugmaker has “never discussed” the FDA’s vaccine guidelines with the White House and “will never do so as it could undermine the agency’s independence.”

Pfizer’s competitors Moderna, AstraZeneca, and Johnson & Johnson are working on longer research timelines.

Vaccine development typically takes years, but the U.S. government has invested billions in efforts to accelerate the process and help multiple drugmakers prepare multiple candidates. All the doses will be purchased by the federal government for use vaccinating the U.S. population.

LIMITED EFFECT

Beyond exposing the rift between the White House and the FDA, the delay in releasing the guidelines may have had limited practical effect.

FDA scientists have been discussing the guidelines publicly for weeks and have made clear that the recommendations have already been shared with each of the vaccine developers.

Former FDA Commissioner Scott Gottlieb said Tuesday that drugmakers depend on the FDA’s science-based endorsement to vouch for the safety and effectiveness of their products.

“I can’t imagine a circumstance where a sponsor would challenge or seek to undermine the FDA’s role here,” Gottlieb said at the covid-19 symposium. “This is precisely the moment when we need an objective, neutral arbiter.”

“There are few moments I can think of where so much political dust was created by political officials for so little actual, practical effect,” Gottlieb said.

Last week, Gottlieb and six other former FDA commissioners blasted the Trump administration for “undermining the credibility” of the agency in a op-ed calling for the release of the then-stalled vaccine guidelines.

“Scientists should make decisions based on data, unfettered by political pressure or the intrusions of ideology or vested interests,” the officials wrote.

NEW YORK ACTIONS

Additionally, New York Gov. Andrew Cuomo said Tuesday that the state will reinstate restrictions on businesses, churches and schools in and near areas where coronavirus cases are spiking, saying the severity of shutdowns would vary by proximity to the hot spots.

Set to take effect no later than Friday, the new rules would be imposed in parts of Brooklyn and Queens in New York City, sections of Orange and Rockland counties in the Hudson Valley, and an area within Binghamton in the Southern Tier.

“This is about protecting people and saving lives,” said Cuomo, a Democrat.

In the hearts of the hot spots — color-coded as red zones — schools would close to in-person learning, only essential businesses could remain open, houses of worship would be limited to no more than 10 people, and restaurants could offer only take-out and delivery.

Those areas would be surrounded by orange-coded zones where schools also would be remote-only, and “high-risk” nonessential enterprises — such as gyms and personal-care businesses — would be closed. Religious institutions would be restricted to 25 people, and restaurants would be allowed limited outdoor dining.

A wider “yellow” caution zone would have schools and businesses open, and restrictions would be lighter than in other zones.

In Wisconsin, Gov. Tony Evers’ administration issued a new order Tuesday limiting the size of public indoor gatherings as covid-19 spreads unchecked across the state.

Wisconsin has become one of the worst hot spots for the disease over the past month, with experts attributing the spike in cases to colleges and schools reopening, and general fatigue about wearing masks and social distancing. The state ranked third nationwide this week in the number of new cases per capita, with 548 cases per 100,000 people, according to Johns Hopkins University.

The order from state Department of Health Services Secretary Andrea Palm, a member of Evers’ Cabinet, limits public indoor gatherings to 25% of the room or building’s capacity. Gatherings in indoor spaces without an occupancy limit will be limited to 10 people. The order does not apply to colleges, schools, churches, polling locations, political rallies and outdoor venues.

The limits take effect Friday and run through Nov. 6. Violators could face forfeitures of up to $500.