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FDA says benefits outweigh risks for Pfizer/BioNTech COVID-19 vaccine in children

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Scientists at the U.S. Food and Drug Administration (FDA) said on Friday that the likely benefits of giving the Pfizer/BioNTech COVID-19 vaccine to 5 to 11 year olds clearly outweigh the risks of rare cases of heart inflammation.

Earlier on Friday, the vaccine makers said their shot showed 90.7% efficacy against the coronavirus in a clinical trial of children 5 to 11 years old.

The details were in briefing documents published ahead of a meeting of a panel of outside experts scheduled to vote on Tuesday whether to recommend the FDA authorize the shots for the young age group.

If the FDA authorizes the Pfizer/BioNTech immunization for children 5 to 11 years old, it would be the first COVID-19 vaccine for the age group and shots could be available in the United States in early November.

Both the Pfizer/BioNTech and Moderna Inc vaccines have been linked to rare cases of heart inflammation called myocarditis, especially in young men.

The FDA staff said that, assuming the number of myocarditis cases observed in the younger age group would be similar to that seen in 12 to 15 year olds, the number of COVID-19 related hospitalizations prevented would outnumber myocarditis-related hospitalizations in most scenarios analyzed.

Pfizer suggested in its own briefing documents that the rate of myocarditis in the age group was likely to be lower than observed in vaccinated 12 to 15 year olds, in part because the younger children were given a lower dose.

The 5 to 11 year olds were given two shots of a 10-microgram dose, a third of what was given to people 12 years and older.

Sixteen children in the trial who had received a placebo got COVID-19, versus three who were vaccinated, Pfizer said in briefing documents submitted to the FDA.

Because more than twice as many children in the 2,268-participant trial were given the vaccine than placebo, that equates to better than 90% efficacy.

Pfizer’s clinical trial in those 5 to 11 years old was not primarily designed to measure efficacy against the virus.

Instead, it compared the amount of neutralizing antibodies induced by the vaccine in the children to the response of older recipients in their adult trial.

Based on those results, Pfizer and BioNTech said last month that their COVID-19 vaccine induced a robust immune response in the children. The FDA staff said the vaccine met the agency’s criteria for the immune response it generated in the children.

EXPANDED TRIAL

Pfizer also said on Friday that it had expanded its clinical trial to improve its safety data, more than doubling the number of children enrolled.

According to Pfizer, the adverse event profile in the expanded group did not suggest any new safety concerns from the vaccine. The company had said previously that the safety profile in the age group was generally comparable to 16 to 25 year olds.

The second cohort of children have been observed for a shorter time. All of them had received their second dose and more than 70% were more than two weeks post dose two.

The Pfizer/BioNTech vaccine already has U.S. regulatory authorization for people who are at least 12 years old, including full FDA approval in August for those 16 and up.

Around 190 million people in the United States are fully vaccinated, including more than 11 million who are 12 to 17 years old that have received the Pfizer vaccine.

If the FDA authorizes the vaccine for 5 to 11 year olds, a group of advisers to the U.S. Centers for Disease Control and Prevention (CDC) will meet on Nov. 2-3 to make recommendations to the agency on how the shots should be administered.

Most states wait for the CDC to sign off on recommendations for vaccines before they begin administering shots.

(Reporting by Michael Erman; editing by John Stonestreet, Mark Porter, Peter Henderson and Himani Sarkar)

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Study suggests Pfizer COVID-19 vaccine only partially protects against Omicron – Toronto Sun

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The Omicron variant can partially evade protection from two doses of Pfizer and partner BioNTech’s COVID-19 vaccine, the research head of a laboratory at the Africa Health Research Institute in South Africa said on Tuesday.

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But the study showed that blood from people who had received two doses of the vaccine and had a prior infection was mostly able to neutralize the variant, suggesting that booster doses of the vaccine could help to fend off infection.

The Omicron variant, first detected in southern Africa last month, has triggered alarms globally of another surge in infections, with more than two dozen countries from Japan to the United States reporting cases.

The World Health Organization classified it on Nov. 26 as a “variant of concern,” but said there was no evidence to support the need for new vaccines specifically designed to tackle the Omicron variant with its many mutations.

Alex Sigal, a professor at the research institute, said on Twitter there was “a very large drop” in neutralization of the Omicron variant relative to an earlier strain of COVID-19.

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A separate lab test by virologist Sandra Ciesek of the University Hospital Frankfurt painted a somewhat bleaker picture.

Exposing the blood of vaccinated individuals to different virus variants, she found that the ability to mount an antibody response to Omicron in people who had three shots of BioNTech/Pfizer was up to 37 times lower than the response to Delta.

An antibody response to Omicron half a year after a two-shot regimen of Pfizer/BioNTech, Moderna or a mixed course of AstraZeneca/BioNTech was not even measurable, Ciesek added.

She posted only selected findings on Twitter, not including the number of samples, and the university said the paper had not yet been published.

“The set of data underscores that it makes sense to develop a vaccine that is adapted to Omicron,” Chiesek tweeted, adding that no conclusion could be drawn about protection against severe disease.

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WHO’s chief scientist, Soumya Swaminathan, said a large drop in the antibody response of vaccinated people to Omicron had been expected.

“This does not mean the vaccine will not work – T-cell immunity (is) likely to persist,” she said on Twitter, referring to a cellular immune response that is believed to prevent severe disease as a second line of immune defence.

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Researchers including Carsten Watzl of the German Society of Immunology and Penny Ward, visiting professor at King’s College London, said the findings underscored the need to get booster shots because a three-shot course would likely continue to protect against severe disease.

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Sigal’s lab tested blood from 12 people who had been vaccinated with two doses of the Pfizer/BioNTech vaccine, according to a manuscript posted on the website for his lab. The preliminary data in the manuscript has not yet been peer reviewed.

Blood from five out of six people who had been vaccinated as well as previously infected with COVID-19 still neutralized the Omicron variant, the manuscript said.

“These results are better than I expected. The more antibodies you got, the more chance you’ll be protected from Omicron,” Sigal said on Twitter.

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He said the lab had not tested the variant against blood from people who had received a booster dose, because they are not available in South Africa yet.

According to the manuscript, the lab observed a 41-fold decline in levels of neutralizing antibodies against the Omicron variant.

Sigal said on Twitter that figure is likely to be adjusted after his lab does more experiments.

While neutralizing antibodies are an indicator of the body’s immune response, scientists believe other kinds of cells such as B-cells and T-cells are also stimulated by the vaccines and help protect against the effects of the coronavirus.

The preliminary data does not indicate that the vaccine is less able to prevent severe illness or death. While lab tests are under way, BioNTech CEO Ugur Sahin said last week “we think it’s likely that people will have substantial protection against severe disease caused by Omicron.”

There is not significant data yet on how vaccines from Moderna, Johnson & Johnson and other drugmakers hold up against the new variant. All the manufacturers, including Pfizer and BioNTech, are expected to release their own data within weeks.

BioNTech’s Sahin told NBC News on Tuesday that the drugmaker has data coming on Wednesday or Thursday.

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Seven Omicron variant cases in Simcoe County linked to travellers from Nigeria – BayToday.ca

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The Simcoe Muskoka District Health Unit says it is investigating a household cluster in Simcoe County with seven confirmed COVID-19 cases that have a strong probability of being the Omicron variant of concern. All the cases are currently isolating at home.

“The cluster is linked to travellers who arrived in Simcoe County from Nigeria in late November,” says a news release.

The Simcoe Muskoka Health Unit borders the North Bay Parry Sound District Health Unit to the immediate south.

“Although the health unit is awaiting whole genomic sequencing of the samples which should be available in the next 7 to 14 days, given the travel history and the preliminary laboratory screening results, the likelihood of an Omicron cluster is very high.”

The Unit’s case and contact management team is currently following up with each case to identify close contacts regarding isolation and testing.

“Scientific data about the Omicron variant is still emerging,” said Dr. Charles Gardner, Medical Officer of Health. “Early evidence suggests that the variant might be more transmissible. While we continue to closely monitor this local situation, I urge all residents to remain vigilant about following public health measures, to monitor themselves for symptoms of COVID-19 and seek testing immediately if any should develop, and get vaccinated if they have not already done so.”

The rate of COVID-19 infection among the unvaccinated vaccine-eligible Simcoe Muskoka population is seven times higher than it is for the fully vaccinated population and the rate of COVID-19 hospitalizations is 15 times higher says Gardner. Getting the vaccine can lower the risk of serious illness, hospitalization, and death.

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Eating disorder symptoms and self-harm linked to higher levels of depression and anxiety during COVID-19 pandemic – Medical Xpress

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Timeline of ALSPAC assessments. NEET Not in education, employment or training. Gray text indicates the name of the ALSPAC questionnaire. Credit: DOI: 10.1186/s40337-021-00510-9

Young adults with previous self-harm or eating disorders reported higher levels of depression and anxiety during the pandemic, even when restrictions had eased, according to new research.

The study, led by the University of Bristol and funded by Elizabeth Blackwell Institute, Medical Research Council and Medical Research Foundation, has been published in the Journal of Eating Disorders. It looked at questionnaire information for 2,657 individuals from world-renowned health study Children of the 90s (also known as the Avon Longitudinal Study of Parents and Children) before and during the COVID-19 pandemic.

Researchers analyzed the relationship between previous reports of eating disorder symptoms and before the pandemic, and (symptoms of depression and anxiety) and mental wellbeing during the COVID-19 pandemic. The study also assessed whether , such as more sleep, relaxation techniques, or visiting green space, could be linked to and wellbeing in young adults with and without previous eating disorder symptoms or self-harm.

Researchers studied questionnaire data from 2017, when the participants were then aged 25 years, as well as data taken during the pandemic in 2020.

At age 25, 32 percent of the 2,657 young adults reported at least one eating disorder , 9 percent reported self-harm, and 5.5 percent reported both an eating disorder symptom and self-harm in the last year.

During the pandemic, those with previously reported eating disorder symptoms and/or self-harm had more symptoms of depression and anxiety, and worse mental wellbeing, compared to individuals without previous symptoms. This remained the case after adjusting for their pre-pandemic levels of depression, anxiety and mental wellbeing.

Lifestyle changes appeared to have little effect on the increased risk for mental health problems in those with prior eating disorder symptoms or self-harm.

Lead author Dr. Naomi Warne, Senior Research Associate at the University’s Centre for Academic Mental Health, said: “Eating and self-harm are common and troubling mental health problems among . In the UK, approximately 1.25 million people are living with an eating disorder and almost 1 in 15 adults report self-harm.

“Our research has highlighted individuals with prior self-harm and eating disorder symptoms are key risk groups and further longitudinal research is needed to understand their ongoing mental health as well as risk and protective factors.

“Individuals with previous eating disorder symptoms and self-harm should be considered vulnerable to depression and anxiety throughout the pandemic and beyond. Funding for rapid and responsive service provision is essential to reduce the impact of the on those with mental health problems.”


Explore further

One in four adults with depression or anxiety lacked mental health support during pandemic


More information:
Naomi Warne et al, Disordered eating and self-harm as risk factors for poorer mental health during the COVID-19 pandemic: a UK-based birth cohort study, Journal of Eating Disorders (2021). DOI: 10.1186/s40337-021-00510-9

Citation:
Eating disorder symptoms and self-harm linked to higher levels of depression and anxiety during COVID-19 pandemic (2021, December 8)
retrieved 8 December 2021
from https://medicalxpress.com/news/2021-12-disorder-symptoms-self-harm-linked-higher.html

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