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COVID: Antiviral Purchased by U.K. Government Does Not Lower Risk of Hospital Admission, Trial Shows
Molnupiravir, a COVID-19 antiviral drug bought by the U.K. government in the amount of 2.23 million doses, is no better than a placebo at lowering the risks of death and hospital admission, a pivotal U.K. trial has found.
Preliminary results released from the Panoramic trial of 25,783 people who were randomly assigned to open-label treatment with molnupiravir plus usual care or to usual care alone found no significant difference between the two groups for the primary endpoint of death or hospital admission. The study has been published as a preprint and has not yet been peer-reviewed.
The U.K. was the first country to authorize Merck Sharp and Dohme’s molnupiravir (Lagevrio) for the treatment of mild-to-moderate COVID-19 in adults with at least one risk factor for severe illness, in November 2021. The European Medicines Agency has still not approved the drug.
The Panoramic study is still open and is now studying a second oral antiviral, Paxlovid, which entered the study on April 12, 2022. The National Institute for Health and Care Excellence is also currently assessing molnupiravir.
Florida Surgeon General Recommends That Adult Men Under 40 Stay Away From COVID mRNA Vaccines
Florida Surgeon General Dr. Joseph Ladapo is recommending that adult men under 40 stay away from the COVID-19 mRNA vaccines. The new guidance was issued Friday and states that a Florida Department of Health analysis on COVID-19 mRNA vaccines showed an increased risk of cardiac-related death among men ages 18-39.
“The Florida Department of Health (Department) conducted an analysis through a self-controlled case series, which is a technique originally developed to evaluate vaccine safety,” a news release from the Florida Department of Health states.
“This analysis found that there is an 84% increase in the relative incidence of cardiac-related death among males 18-39 years old within 28 days following mRNA vaccination. With a high level of global immunity to COVID-19, the benefit of vaccination is likely outweighed by this abnormally high risk of cardiac-related death among men in this age group.”
Ladapo first released this new guidance in a tweet. The tweet was taken down for a few hours over the weekend after Twitter flagged it as misinformation, but it was later restored.
Pfizer Exec Denies CEO Negotiated EU COVID Vaccine Contract via Text Message
A Pfizer (PFE.N) executive with a lead role in negotiating a COVID-19 vaccine bulk supply agreement with the European Commission “categorically” ruled out that the U.S. drugmaker’s chief executive agreed to the contract via mobile phone text messages.
“As to whether a contract negotiation such as this contract which you referred to, 1.8 billion doses, was negotiated through an SMS, I can categorically tell you that would not be the case,” Janine Small, president of international developed markets at Pfizer, told the European Parliament’s special committee on COVID-19 on Monday.
In an interview with The New York Times in April 2021, European Commission President Ursula von der Leyen revealed she had exchanged texts with Pfizer Chief Executive Albert Bourla for a month while the contract was under negotiation, prompting calls to publish the exchange.
The Commission said in June this year that it no longer had the texts, which later drew criticism from the European Union’s ombudswoman.
AstraZeneca’s COVID Vaccine Suffers a Setback in Nasal Spray Trial
Attempts by Oxford University researchers and AstraZeneca Plc (AZN.L) to create a nasal-spray version of their jointly developed COVID-19 shot suffered a setback on Tuesday as initial testing on humans did not yield the desired protection.
Antibody response in the respiratory mucous membranes was seen in only a minority of participants in the trial, which was in the first of usually three phases of clinical testing, the University of Oxford said in a statement on Tuesday. Also, the immune response measured in the blood was weaker than that from a shot-in-the-arm vaccination.
Researchers across the world have placed high hopes on nasal spray vaccines against the coronavirus because the method is believed to potentially prevent infection and not just disease as it may prompt an immune response directly in the airways, where the virus enters the body.
Regulators in India and China have already cleared products that are administered through the airways.
Biden Administration Scrambling to Get More People Boosted Before Winter
The Biden administration is racing against the dropping temperatures to convince more Americans to get the updated COVID-19 booster shot amid low uptake numbers driven by confusion over the shot, declining cases and profound pandemic fatigue.
By the end of last week, the administration expected between 13 and 15 million people out of 283.4 million Americans aged 12 and up will have opted to get the updated Moderna or Pfizer jab ahead of what officials warn could be another deadly COVID winter.
That’s just five percent of the eligible population — a sign of the stark challenge facing a Biden administration that has positioned October as a make-or-break month for the overall success of its booster campaign. Top health officials have downplayed the low takeup, saying the numbers are a good start.
But ahead of the critical stretch, doctors and advocates said people are burned out, tuned out and don’t understand why they need another booster. And even some administration officials privately acknowledge there’s little internal expectation they’ll see an explosion of interest.
Coronavirus in the U.S.: Where Cases Are Growing and Declining
Although the Omicron subvariant BA.5 is currently causing most new COVID-19 cases in the United States, a new emerging variant could drive another winter surge, according to White House chief medical adviser, Anthony Fauci.
BA.5 accounts for nearly 81% of the genetically sequenced samples collected in the U.S. between September 25 and October 1, but the number of cases caused by another Omicron subvariant called BA.4.6 — which is capable of evading immunity from vaccination and previous infection — is steadily rising. It currently accounts for 13% of the sequenced samples.
The growing number of BA.4.6 cases led the U.S. Food and Drug Administration to issue a warning indicating that Evusheld — the only monoclonal antibody authorized for COVID-19 prevention in immunocompromised individuals and people who can’t take the COVID-19 vaccine — may be completely ineffective against subvariants like BA.4.6.
Telemedicine Was Made Easy During COVID. Not Any More
Telemedicine exploded in popularity after COVID-19 hit, but limits are returning for care delivered across state lines. That complicates follow-up treatments for some cancer patients. It also can affect other types of care, including mental health therapy and routine doctor check-ins.
Over the past year, nearly 40 states and Washington, DC, have ended emergency declarations that made it easier for doctors to use video visits to see patients in another state, according to the Alliance for Connected Care, which advocates for telemedicine use.
Doctors say the resulting patchwork of regulations creates confusion and has led some practices to shut down out-of-state telemedicine entirely. That leaves follow-up visits, consultations or other care only to patients who have the means to travel for in-person meetings.
Medium COVID Could Be the Most Dangerous COVID
As the pandemic drags on, data have emerged to clarify the dangers posed by COVID across the weeks, months and years that follow an infection. Taken together, their implications are surprising. Some people’s lives are devastated by long COVID; they’re trapped with perplexing symptoms that seem to persist indefinitely. For the majority of vaccinated people, however, the worst complications will not surface in the early phase of the disease, when you’re first feeling feverish and stuffy, nor can the gravest risks be said to be “long term.”
Rather, they emerge during the middle phase of post-infection, a stretch that lasts for about 12 weeks after you get sick. This period of time is so menacing, in fact, that it really ought to have its own, familiar name: medium COVID.
Just how much of a threat is medium COVID? The answer has been obscured, to some extent, by sloppy definitions. A lot of studies blend different, dire outcomes into a single giant bucket called “long COVID.” Illnesses arising in as few as four weeks, along with those that show up many months later, have been considered one and the same.
Long COVID Disables Millions Worldwide, Even as Rates Ease, Study Shows
Long COVID eases with time, according to a study that found about 1% of coronavirus patients had persistent symptoms for a year or more.
In the first rigorous assessment of the magnitude of long COVID on a global scale, researchers found that 6.2% of people who had COVID-19 in the pandemic’s first two years experienced at least one of three main groups of symptoms three months later. Of those patients, 15% were still afflicted after a year, they found.
Although the probability of having chronic health problems from COVID is relatively low, the vast number of cases — at least 670 million worldwide — leaves a substantial burden of disability, said Christopher Murray, director of the Institute for Health Metrics and Evaluation at the University of Washington, where the study was conducted.
Long COVID’s effects are, on average, similar to what occurs after a moderate-to-severe traumatic brain injury or complete deafness, said Theo Vos, a professor of health metrics sciences at the university, who led the study.
Swiss Drugs Regulator Approves One of Pfizer’s COVID Booster Shots
Swiss drugs regulator Swissmedic said on Monday it had temporarily approved Pfizer‘s COVID-19 booster shot targeting the original and BA.1 Omicron coronavirus variants.
Swissmedic added that the data currently available to it was not yet sufficient to make a decision on Pfizer’s bivalent booster vaccine targeting the BA.4 and BA.5 Omicron variants.
FDA Expands Use of GSK’s Vaccine During Pregnancy to Prevent Whooping Cough in Infants
The U.S. Food and Drug Administration on Friday allowed the use of GlaxoSmithKline’s (GSK.L) Boostrix vaccine during the third trimester of pregnancy to prevent whooping cough in infants younger than two months of age.
While the FDA’s approval of Boostrix has always included its use during pregnancy to protect the vaccinated individual, the latest decision expands its use to help prevent pertussis, commonly known as whooping cough, in infants younger than two months.
The health regulator first approved the vaccine in 2005, for use in adolescents ages 10 years through 18 years as a single-dose shot to prevent tetanus, diphtheria and whooping cough, and later allowed its use in adults as well as for those aged 65 and older.
