Pfizer CEO confident Covid treatment pill will be effective against omicron variant


Pfizer CEO Albert Bourla said Monday he expects the company’s Covid-19 treatment pill to be effective against the omicron variant of the virus causes Covid-19.

“The good news when it comes to our treatment, it was designed with that in mind, it was designed with the fact that most mutations are coming in the spikes,” Bourla told CNBC’s “Squawk Box.” “So that gives me very high level of confidence that the treatment will not be affected, our oral treatment will not be affected by this virus.”

Pfizer submitted its application earlier this month to the Food and Drug Administration to authorize the pill, Paxlovid, for emergency use. In a clinical trial of people age 18 and over, Pfizer found the pill reduces hospitalization and death by 89% when taken with a widely used HIV drug within three days of the start of symptoms.

While Bourla was optimistic about the efficacy of Paxlovid, he said the impact of omicron on the company’s two-dose vaccine remains to be seen.

“I don’t think that the result will be the vaccines don’t protect,” Bourla said. “I think the result could be, which we don’t know yet, the vaccines protect less.”

Bourla said Pfizer has already begun work to manufacture a new vaccine if necessary. The company made its first DNA template on Friday, he said, the initial step in the development process.

“We have made multiple times clear that we would be able to have the vaccine in less than 100 days,” Bourla said. He noted that the company was able to create vaccines for the beta and delta variants quickly, though they ultimately weren’t used because the original shots remained effective.

Pills could prove COVID game changer


Harvard experts in medical therapeutics say the recent development of pills to treat COVID-19 may turn out to be a pandemic game changer for a simple reason: When it comes to treating the ailment, the earlier the better.

Mark Namchuk, executive director of Harvard Medical School’s Therapeutics Initiative, said pills have some clear advantages over existing treatments — the drug remdesivir and a handful of antibody therapies — because they are by comparison easy to transport, store, and administer. The other treatments must be given intravenously and have largely been reserved for use by the sickest patients confined to medical facilities late in their illness’ course.

Namchuk said that assuming the pills are made widely available, they can be prescribed soon after symptoms start at home, with nothing else required to administer them beyond possibly a glass of water.

“They’re both oral, so much easier to get them distributed to folks early in their illness and make them more broadly available,” said Namchuk, professor of the practice of biological chemistry and molecular pharmacology. “The efficacy is very encouraging, but the route of administration opens up the possibility of using it more broadly.”

The assessment comes after reports by Merck and Ridgeback Biotherapeutics that their COVID-19 pill — currently being reviewed by federal regulators — lowers risk of hospitalization and death by 50 percent, and on the heels of last week’s promising results by Pfizer Inc., which said a Phase 2/3 study of its pill showed that it cuts risk of hospitalization and death by 89 percent. The Pfizer results were so promising the study was halted early, the company said. About 1 percent of study participants (6 out of 607) were hospitalized, and none died after 28 days. That compared with 6.7 percent (41 out of 612) hospitalized in the control group, with 10 subsequently dying. The company also plans to seek FDA emergency use authorization to market the pill.

US reopens border to UK travellers after almost two years


UK visitors are now able to travel to the US for the first time in nearly two years.

The border reopened at 05:01 GMT and the first flights take off from Heathrow at 08:30 – but all UK visitors over 18 will have to provide proof of vaccination to enter the US.

American travellers have been able to travel to the UK since 28 July.

Transport Secretary Grant Shapps has called this a “significant moment” for UK-US travel.

Transatlantic flights, he added, are “at the heart of UK aviation”.

In addition to the UK, the travel ban is being lifted for people from Brazil, China, India, Ireland, South Africa, Iran and the Schengen countries – a group of 26 European nations.

Antibody drugs could protect people with weak immune systems against Covid


Even as the Covid delta wave ebbs in the U.S., millions of people with compromised immune systems remain trapped in an anxious and sequestered limbo. A considerable portion of this population, research indicates, remains highly vulnerable to the coronavirus even after three or four vaccine shots.

Many immunocompromised Americans, including people with cancer, autoimmune disorders and transplanted organs, are impatiently awaiting what could be their ticket back to some semblance of normalcy: the ability to receive periodic injections of long-acting monoclonal antibodies. This, research suggests, could provide them the substantial protection against Covid-19 that in their cases vaccination may not.

The Food and Drug Administration could soon grant emergency authorization to monoclonal antibodies from drugmaker Regeneron for what is known as pre-exposure prophylaxis, or PrEP, against Covid-19. If cleared by the FDA, Regeneron’s therapy could be given as a set of injections every one to three months before potential exposure to the coronavirus.

70% of US adults are fully vaccinated, 80% partially: White House


The White House announced on Monday that 70 percent of adults in the U.S. are fully vaccinated against COVID-19 and that 80 percent of adults have received at least their first shot.

Jeff Zients, the White House COVID-19 response coordinator, disclosed the statistics during a press briefing Monday morning, saying that the U.S. has “hit two important milestones.”

Cyrus Shahpar, the White House COVID-19 data director, said in a tweet that more than 935,000 doses were administered in the past day, including 240,000 initial shots and 571,000 additional doses and boosters.

Zients also announced that by the end of Monday, roughly 20 million Americans will have received Pfizer-BioNTech, Moderna or Johnson & Johnson booster dose.

The coordinator said the U.S.’s booster program “is off to a very strong start and continues to accelerate.”

The U.S. reached the 80 percent partially vaccinated number less than a month after the White House announced that 75 percent of adults in the U.S. had received at least one shot.

The milestones come as COVID-19 cases and deaths are trending downward in the U.S., likely due in large part to the highly effective vaccines.

U.S. Covid cases fall to less than half of peak delta levels


U.S. Covid cases have fallen to less than half of the pandemic’s most recent peak, a sign that the country may be moving past the punishing wave brought on by the delta variant this summer.

The U.S. reported an average of 72,000 new cases per day over the past week, according to data compiled by Johns Hopkins University, down 58% from the most recent high mark of 172,500 average daily cases on Sept. 13. Vaccination rates have also risen in recent months — albeit more slowly than when the shots were first rolled out — to nearly 58% of fully vaccinated Americans as of Thursday, Centers for Disease Control and Prevention data shows.

“Personally, I’m optimistic that this may be one of the last major surges, and the reason for that is because so many people have been vaccinated, and also because a lot of people have had Covid,” said Dr. Arturo Casadevall, chair of molecular microbiology and immunology at the Johns Hopkins Bloomberg School of Public Health. “We now have a lot of immunity in the population.”

Hospitalizations are also falling. About 51,600 Americans are currently hospitalized with Covid, according to a seven-day average of data from the Department of Health and Human Services, roughly half of the 103,000 Covid patients reported at the most recent high point in early September. And while the U.S. is still reporting 1,400 daily Covid deaths, that figure is down 33% from the latest peak of nearly 2,100 deaths per day on Sept. 22.

Case counts have fallen in every U.S. region, most sharply in the South, where the delta wave hit hardest over the summer.

COVID-19 vaccine gives 5 times the protection of ‘natural immunity,’ data show


US adults who previously had COVID-19 contracted the disease at more than five times the rate of those who were fully vaccinated, according to data published today in Morbidity and Mortality Weekly Report (MMWR).

Rolling out vaccines during a pandemic is not easy, and people can get confused by evidence that shows COVID vaccines don’t work perfectly, including a study yesterday showing that household spread with the Delta (B1617.2) variant still happens after vaccination, albeit not as readily in the unvaccinated and not leading to severe cases (see today’s CIDRAP News story).

Yet the body of evidence continues to grow that, despite their imperfections, COVID-19 vaccines continue to work very well, and today’s study adds to that. Officials with the Centers for Disease Control and Prevention (CDC), who led the study, say of the results, “All eligible persons should be vaccinated against COVID-19 as soon as possible, including unvaccinated persons previously infected with SARS-CoV-2.”

Unvaccinated at 5.5 times the risk

The researchers looked at data from nine states on 201,269 hospitalizations for COVID-like illness from Jan 1 to Sep 2, 2021. Of these, 94,264 had molecular testing for SARS-CoV-2, and 7,348 (7.8%) had lab-confirmed COVID-19. Among that group, 1,020 hospitalizations were among previously infected and unvaccinated people, and 6,328 cases were among fully vaccinated people who were not previously infected.

Lab-confirmed COVID-19 was found in 324 (5.1%) of the fully vaccinated people and in 89 (8.7%) of the unvaccinated, previously infected people.

In comparing unvaccinated people who were infected 90 to 179 days after a previous infection compared with those who were vaccinated 90 to 179 days before their COVID infection, the researchers found the incidence of infection to be 5.49 times higher in the unvaccinated (95% confidence interval, 2.75 to 10.99).

Common antidepressant fluvoxamine slashes risk of COVID death


A cheap, widely available drug used to treat mental illness cuts both the risk of death from COVID-19 and the need for people with the disease to receive intensive medical care, according to clinical-trial results1.

The drug, called fluvoxamine, is taken for conditions including depression and obsessive–compulsive disorder. But it is also known to dampen immune responses and temper tissue damage, and researchers credit these properties for its success in the recent trial. Among study participants who took the drug as directed and did so in the early stages of the disease, COVID-19-related deaths fell by roughly 90% and the need for intensive COVID-19-related medical care fell by roughly 65%.

“A major victory for drug repurposing!” Vikas Sukhatme at Emory University School of Medicine in Atlanta, Georgia, who studies drug repurposing, wrote in an e-mail to Nature. “Fluvoxamine treatment should be adopted for those at high risk for deterioration who are not vaccinated or cannot receive monoclonal antibodies.”

Study co-author Angela Reiersen, a psychiatrist at Washington University School of Medicine in St. Louis, Missouri, has long been interested in using fluvoxamine to treat a rare genetic condition. While monitoring the fluvoxamine literature before the pandemic, she came across a 2019 study showing that fluvoxamine reduced inflammation in mice with sepsis2. When COVID-19 hit, “I immediately thought back to that paper with the mice,” she says.

Reiersen and her colleagues partnered with the organizers of the TOGETHER Trial, which aims to identify approved drugs that can be repurposed to treat COVID-19. The team’s study included 1,497 people in Brazil who had COVID-19 and were at high risk of severe disease. Roughly half received fluvoxamine, and the rest received a placebo.

The trial’s results, published on 27 October, mean that fluvoxamine is one of a handful of therapies that show strong evidence of preventing progression from mild to severe COVID-19. The only early-stage treatments currently recommended by the US National Institutes of Health are monoclonal antibodies, which are costly and difficult to administer in an outpatient setting.

People Vaccinated Against COVID Less Likely to Die from Any Cause


People who have been vaccinated against COVID-19 are not only less likely to die from the virus, but they’re also less likely to die from any cause in the months following vaccination, according to a new study.

The study team, which included researchers from the CDC and health care groups across seven states, found the results while studying the safety of the three authorized COVID-19 vaccines.

The results were published Friday in the CDC’s Morbidity and Mortality Weekly Report.

“COVID-19 vaccines authorized in the United States have shown again and again to be safe. This study also confirms their safety,” Stanley Xu, who led the study team and is a researcher at the Kaiser Permanente Southern California Department of Research and Evaluation, told CNN.

“In fact, it shows that people vaccinated for COVID-19 had lower death rates than those who were not vaccinated, even when COVID deaths were excluded,” he said. “That’s in addition to the mounting evidence from other studies showing that the COVID-19 vaccines are effective against COVID-19 infection, serious illness, and death.”

The research team studied 11 million people, including 6.4 million people who had been vaccinated against COVID-19 and 4.6 million people who had received flu shots in recent years but hadn’t received a COVID-19 vaccine. They filtered out anyone who had died from COVID-19 to analyze the non-coronavirus deaths.

Between December 2020 to July 2021, COVID-19 vaccine recipients had lower rates of non-COVID-19 mortality than unvaccinated people, including adjustments for age, race and ethnicity, sex, and geographic location.

Those who received two doses of the Pfizer vaccine were 34% as likely to die from non-coronavirus causes in the months after vaccination as unvaccinated people. Those who received two doses of the Moderna vaccine were 31% as likely to die as unvaccinated people, and those who received the one-shot Johnson & Johnson vaccine were 54% as likely to die.

One explanation could be that people who get vaccinated, in general, tend to be healthier than people who don’t, the researchers said, noting that they plan to study this more in the future.

“There is no increased risk for mortality among COVID-19 vaccine recipients,” they wrote. “This finding reinforces the safety profile of currently approved COVID-19 vaccines in the United States.”