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

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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.



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Limiting TV ads for foods high in sugar, salt, fat may reduce child obesity

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Limiting TV ads for sugary, salty and high-fat foods and drinks might help reduce childhood obesity, British researchers suggest.

They looked at advertising of these products between 5:30 a.m. and 9 p.m. If all such ads were withdrawn during those hours, the number of obese kids in Britain between the ages of 5 and 17 would drop by 5% and the number of overweight kids would fall 4%, the study found.

That’s equivalent to 40,000 fewer kids in Britain who would be obese and 120,000 fewer who would be overweight, the researchers said.

The findings were published online this week in the journal PLOS Medicine.

Oliver Mytton, an academic clinical lecturer at the Center for Diet and Activity Research at the University of Cambridge, led the study.

“Measures which have the potential to reduce exposure to less-healthy food advertising on television could make a meaningful contribution to reducing childhood obesity,” the authors said in a journal news release.

But they also pointed out that they could not fully account for all factors that would affect the impact of the policy, if implemented.

They added: “Children now consume media from a range of sources, and increasingly from online and on-demand services, so in order to give all children the opportunity to grow up healthy it is important to ensure that this advertising doesn’t just move to the 9-10 pm slot and to online services.”

More information

For more on childhood obesity, visit the U.S. Centers for Disease Control and Prevention.

Copyright 2020 HealthDay. All rights reserved.



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Blood type may predict risk for severe COVID-19, studies say

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There’s more evidence that blood type may affect a person’s risk for COVID-19 and severe illness from the disease.

The findings are reported in a pair of studies published Oct. 14 in the journal Blood Advances.

In one, researchers compared more than 473,000 people in Denmark with COVID-19 to more than 2.2 million people in the general population.

Among the COVID-19 patients, there was a lower percentage of people with blood type O and higher percentages of those with with types A, B and AB.

The findings suggest that people with A, B or AB blood may be more likely to be infected with COVID-19 than people with type O blood. Infection rates were similar among people with types A, B and AB blood.

The other study included 95 critically ill COVID-19 patients hospitalized in Canada. Patients with type A or AB blood were more likely to require mechanical ventilation, suggesting that they had greater rates of lung injury from COVID-19.

More patients with type A and AB blood required dialysis for kidney failure, the study added.

The results suggest that COVID-19 patients with A and AB blood types may have an increased risk of organ dysfunction or failure than those with type O or B blood, according to the researchers.

They also found that while people with blood types A and AB didn’t have longer overall hospital stays than those with types O or B, on average, they were in intensive care longer, which may indicate more severe COVID-19.

“The unique part of our study is our focus on the severity effect of blood type on COVID-19. We observed this lung and kidney damage, and in future studies, we will want to tease out the effect of blood group and COVID-19 on other vital organs,” said study author Dr. Mypinder Sekhon, a clinical instructor in the Division of Critical Care Medicine at the University of British Columbia in Vancouver, Canada.

“Of particular importance as we continue to traverse the pandemic, we now have a wide range of survivors who are exiting the acute part of COVID-19, but we need to explore mechanisms by which to risk stratify those with longer-term effects,” he added in a news release.

More information

The U.S. Centers for Disease Control and Prevention has more on COVID-19.

Copyright 2020 HealthDay. All rights reserved.



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Personality traits govern success of workplace wellness programs, study finds

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Oct. 14 (UPI) — The personality traits of individual employees play a strong role in determining the success of workplace wellness programs designed to boost physical activity, a study published Wednesday by the journal PLOS ONE found.

Those identified as extroverted and motivated significantly improved their daily step counts by an average of 945 steps after participating in a competitive gamification program — which uses elements of game playing to encourage engagement — but did not sustain these gains over a 12-week period, the data showed.

Conversely, gamification programs generated 1,100- to 1,200-step improvements in introverted and less motivated study participants that they sustained over the 12 weeks they were monitored, the researchers said.

“This suggests that ongoing incentives and reminders may be necessary to sustain motivation for some groups of people,” study co-author Dr. Shirley Chen, an assistant professor of medicine at Mount Sinai Health System, said in a statement.

Workplace wellness programs have become increasingly popular as employers seek to improve staff health and well-being. However, recent studies have suggested that they offer limited benefits.

The study by Chen and her colleagues is a follow-up to the 2019 analysis of the STEP UP program, which aimed to increase the step counts of roughly 600 Deloitte professionals classified as being either obese or overweight over a period of six months.

In the STEP UP program, personalized daily step counts were established for each participant, but they were then randomly funneled into four different groups: one that just gave the participants their goals and a step tracker, and three others that mixed in different forms of nudges that were “gamified” using a point system, the researchers said.

For the new analysis, they divided participants into different classifications of certain psychological and behavioral characteristics that the researchers called “phenotypes.”

Study participants completed surveys to help researchers identify personality types and social support needs, according to Chen.

The phenotypes that emerged were “more extroverted and more motivated,” which made up 54% of study participants and “less active and less social,” which was 20%, the researchers said. The remaining participants — 25% — were classified as “less motivated and at-risk.”

The participants then were assigned to one of three gamification programs — supportive, collaborative or competitive.

In the supportive program, participants were asked to identify a friend or family member who encouraged them and received weekly reports on their progress.

Participants in the collaborative program were placed into teams of three and a designated member was selected each day to represent them in their step activity.

Participants in the competitive program were assigned into teams of three and received a weekly “leader-board” email to foster competition.

Although more extroverted and motivated participants in the competitive program saw an uptick in step counts, these same gains were not seen among those in the collaborative or supportive programs, the researchers said.

In addition, gains were not sustained over 12 weeks of follow-up, they said.

However, participants classified as “less active and less social” saw step count improvements ranging from 1,000 to 1,200 in all three programs — and these increases were maintained over the 12-week follow-up period, according to the researchers.

Conversely, those in the “less motivated and at-risk” group had no improvement during the study, the researchers said.

“A one-size-fits-all approach to nudging new behaviors within wellness programs can have limited success,” study co-author Dr. Mitesh Patel, director of the Penn Medicine Nudge Unit, said in a statement.

“We’ve shown that different forms of nudging can be effective, and in this latest study … we’ve now demonstrated that matching nudges to the right behavior profiles can unlock their full potential,” Patel said.



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