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New FDA COVID-19 vaccine guidance requires two months of follow-up data for approval

Oct. 6 (UPI) — New guidelines issued by the U,S. Food and Drug Administration on Tuesday require manufacturers of potential new COVID-19 vaccines to provide two months’ worth of “follow-up” data on safety and possible adverse events.

The mandate would appear to dash President Trump’s hopes of having a new vaccine approved by the Nov. 3 election.

The two-month period was decided upon because agency research suggests that most adverse events or severe side effects with vaccines emerge within two to three months after administration, an FDA administrator said.

“Ideally, we’d like to have longer-term safety follow-up, but we are in the middle of a pandemic and people are dying,” said Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research.

Marks was among several top public health officials who spoke during a virtual symposium Tuesday entitled “Preserv[ing] the Scientific Integrity of COVID-19 Vaccine Development and Allocation,” hosted by Johns Hopkins University and the University of Washington.

The FDA released the new guidance earlier in the day amid reports suggesting that Trump administration officials were pressuring the agency to streamline the vaccine approval process, with an eye toward the presidential election.

The new guidance focuses on the FDA’s emergency use authorization process, which allows the agency to more quickly approve products in response to a national crisis.

The normal safety and effectiveness requirements for drugs, vaccines and medical devices approved under the emergency use program are “deliberately set lower,” Marks said. However, the “known and potential benefits [still] have to outweigh risks,” he said.

To receive an emergency authorization based on the new guidance, potential vaccines will have to provide an “interim analysis” of data proving effectiveness from Phase 3 clinical trials — the final stage of the drug evaluation process.

In addition, data from Phase 3 studies must “include a median follow-up duration of at least two months after completion of the full vaccination regimen to help provide adequate information to assess a vaccine’s benefit-risk profile,” the guidelines state.

This includes information on adverse events, cases of severe COVID-19 disease among study participants and cases of COVID-19 “occurring during the time frame when … the vaccine would be responsible for a protective effect.”

During Tuesday’s symposium, Moncef Slaoui, the scientific head of Operation Warp Speed — the Trump administration’s initiative to spur COVID-19 drug treatment and vaccine research and development — said that several candidate vaccines have begun Phase 3 trials.

However, although he and his colleagues are “reasonably pleased with the progress,” the vaccines farthest along in the process won’t have their “first results” on effectiveness until late November or early December.

Still, “we feel comfortable that we will have one or two vaccines and we will have enough doses to immunize 30 million people in November and December and another 50 million in January and have a serious impact this pandemic,” Slaoui said.

He had told Science magazine in September that he would resign if politics interfered with the vaccine evaluation process.

Experts: Tackling Poverty and Racism as Public Health Crises Requires Rapid Action | National News

Late last month, the Healthcare Anchor Network, a coalition of more than three dozen health systems in 45 states and Washington, D.C., released a public statement declaring: “It is undeniable: Racism is a public health crisis.” In the wake of the killing of George Floyd in May, many states, cities and counties across the United States issued similar declarations, according to the American Public Health Association.

While it is becoming clear that ZIP code may matter more to longevity than genetic code, some public health experts have been sounding the alarm for decades. Indeed, poverty and racism have an enormous – and devastating – impact on health, according to a panel of experts brought together for a webinar hosted by U.S. News & World Report as part of the Community Health Leadership Forum, a new virtual event series.

In Chicago, as just one example, life expectancy between some neighborhoods can vary by 30 years, because of factors like access to health care, education, nutritional food sources, income and what many call systematic disinvestment dating back decades.

COVID-19 has made such inequities impossible to ignore. Expected at first to be “the great equalizer,” hitting all demographics equally hard, the novel coronavirus has caused impoverished, mostly Black and underrepresented minority populations to suffer far more death and ill health effects than their white peers.

COVID-19 “attacks vulnerabilities in a truly diabolical way,” said featured speaker Wes Moore, chief executive officer of Robin Hood, one of the nation’s leading anti-poverty organizations.

“We are going to need a concerted and a collective effort to deal with a calcified and hard problem” of poverty and racism and how they influence health, Moore said. Half of the population of New York City lived in poverty for at least one year over the past four years, Moore said, and the probability of dipping back into poverty within a year was 37% – even before COVID-19 hit. “The data continues to reinforce the fact that … [poverty] is not a choice of the person who is feeling the weight of poverty, it’s society’s choice,” Moore said.

Those in poverty are far more likely to have preexisting conditions like asthma, diabetes and obesity, Moore noted, putting them at greater risk of death from COVID-19 and other illnesses.

In his new book, “Five Days: The Fiery Reckoning of an American City,” Moore examined the 2015 death of Freddie Gray and its aftermath in the city of Baltimore. Moore wrote that Gray, born premature and underweight to a heroin-addicted mother, had grown up in poverty and was exposed to lead at a far greater rate than the limit recommended by the Centers for Disease Control and Prevention. “Freddie Gray never had a shot,” Moore said, because he was failed by every social system, including the health system, and not just law enforcement.

Yet Moore remains optimistic. “We are not yet what we can be; our responsibility to get there is our responsibility to get there,” he said. Citing a