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Pfizer Inc’s experimental antiviral pill to treat COVID-19 was shown to cut by 89% the chances of hospitalization or death for adults at risk of developing severe disease, the company said on Friday, offering what could be a promising new weapon in the fight against the pandemic.
The trial’s results suggest that the oral drug surpasses Merck & Co Inc’s pill, molnupiravir, which was shown last month to halve the risk of dying or being hospitalized for COVID-19 patients at high risk of serious illness.
Pfizer’s pill, with the brand name Paxlovid, could secure U.S. regulatory approval by the end of the year. The Pfizer trial was stopped early due to its high success rate. Full trial data is not yet available from either company.
President Joe Biden said the U.S. government has secured millions of doses of the Pfizer drug.
“If authorized by the FDA we may soon have pills that treat the virus in those who become infected,” Biden said. “The therapy would be another tool in our toolbox to protect people from the worst outcomes of COVID.”
Shares in Pfizer, which also makes one of the mostly widely used COVID-19 vaccines, were up 9% to $47.82, while Merck’s were down 9.3% to $82.09. Shares of vaccine makers took a hit, with Moderna Inc, Pfizer’s German partner BioNTech SE and Novavax all down 13-21%.
The pill is given in combination with an older antiviral called ritonavir. The treatment consists of three pills given twice daily. It has been in development for nearly two years.
Pfizer is in discussions with 90 countries over supply contracts for its pill, Chief Executive Officer Albert Bourla said in an interview.
Bourla said Pfizer expects to price its treatment close to where Merck has priced its pill. Merck’s U.S. contract price for its pill is around $700 for a five-day course of therapy.
Even with the potential offered by the Pfizer and Merck pills, preventing COVID-19 infections through broad use of vaccines remains the best way to control a pandemic that has killed more than 5 million people worldwide, including more than 750,000 in the United States, according to infectious disease experts.
“Vaccines are going to be the most effective and reliable tool that we have in this pandemic,” said Dr. Grace Lee, professor of pediatrics at Stanford University School of Medicine. “These oral medications are going to augment our ability to really reduce the risk of severe disease, hospitalization and death, which is huge, but it won’t prevent infection.”
While more than 7 billion vaccine doses have been administered worldwide, that has covered only about half the world’s people. In the United States, 58% of all people, including 70% of adults, are fully vaccinated. There are more than 400,000 new COVID-19 cases daily worldwide, with infections rising in 50 countries.
Mizuho analyst Vamil Divan forecast a “very minor impact” from the Pfizer drug on vaccination among people who do not want the vaccine or a booster shot as recommended by U.S. health regulators.
“I think there’s a small percentage of people that may decide not to get vaccinated, now that there are good treatment options,” Divan said.
Pfizer said it plans to submit interim trial results for its pill to the Food and Drug Administration (FDA) before the U.S. Thanksgiving holiday on Nov. 25.
The company said it expects to manufacture 180,000 treatment courses by the end of this year and at least 50 million courses by the end of next year, including 21 million in the first half of 2022.
Antivirals need to be given as early as possible, before an infection takes hold, to be most effective.
The planned analysis of 1,219 patients in Pfizer’s study examined hospitalizations or deaths among people diagnosed with mild to moderate COVID-19 with at least one risk factor for developing severe disease, such as obesity or older age.
Among those given Pfizer’s drug within three days of symptom onset, the pill lowered the chances of hospitalization or death for adults at risk of developing severe COVID-19 by 89% compared to patients who received a placebo. Among these patients, 0.8% were hospitalized and none died by 28 days after treatment, compared to a 7% hospitalization rate and seven deaths in the placebo group.
Rates were similar for patients treated within five days of symptoms: 1% of the treatment group was hospitalized, compared to 6.7% for the placebo group, which included 10 deaths. Pfizer said that works out to being 85% effective at preventing hospitalization or death.
An FDA panel of outside experts is scheduled to meet Nov. 30 to discuss Merck’s pill, which was approved by British regulators https://www.reuters.com/business/healthcare-pharmaceuticals/britain-approves-mercks-oral-covid-19-pill-2021-11-04 in a world first on Thursday. Pfizer said it did not know if Paxlovid would be reviewed at that meeting.
Pfizer did not detail side any effects but said adverse events happened in about 20% of both treatment and placebo patients. Possible side effects include nausea and diarrhea.
Pfizer is holding discussions about a license for generic manufacturing of the pill for low-income countries, Unitaid’s Medicines Patent Pool said in a statement.
(Reporting by Deena Beasley; additional reporting by Ankur Banerjee, Leroy Leo and Manojna Maddipatla in Bengaluru; Julie Steenhuysen, Trevor Hunnicut, Michael Erman and Francesco GuarascioEditing by Will Dunham, Anil D’Silva, Caroline Humer and Mark Potter)
Study suggests Pfizer COVID-19 vaccine only partially protects against Omicron – Toronto Sun
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.
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.
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.
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.
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.
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.
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.
Seven Omicron variant cases in Simcoe County linked to travellers from Nigeria – BayToday.ca
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.
“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.
Eating disorder symptoms and self-harm linked to higher levels of depression and anxiety during COVID-19 pandemic – Medical Xpress
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 self-harm before the pandemic, and mental health problems (symptoms of depression and anxiety) and mental wellbeing during the COVID-19 pandemic. The study also assessed whether lifestyle changes, such as more sleep, relaxation techniques, or visiting green space, could be linked to mental health 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 symptom, 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 disorders and self-harm are common and troubling mental health problems among young adults. 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 pandemic on those with mental health problems.”
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
University of Bristol
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
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