New England Journal of Medicine

Study: Pfizer COVID Treatment Pill Showed No Benefit To Younger Adults

By Associated Press
August 25, 2022

Results from a 109,000-patient study show that Paxlovid had no measurable benefit in patients between the ages of 40 and 65.

Pfizer’s COVID-19 pill appears to provide little or no benefit for younger adults, while still reducing the risk of hospitalization and death for high-risk seniors, according to a large study published Wednesday.

The results from a 109,000-patient Israeli study are likely to renew questions about the U.S. government’s use of Paxlovid, which has become the go-to treatment for COVID-19 due to its at-home convenience. The Biden administration has spent more than $10 billion purchasing the drug and making it available at thousands of pharmacies through its test-and-treat initiative.

The researchers found that Paxlovid reduced hospitalizations among people 65 and older by roughly 75% when given shortly after infection. That’s consistent with earlier results used to authorize the drug in the U.S. and other nations.

But people between the ages of 40 and 65 saw no measurable benefit, according to the analysis of medical records.

The study has limitations due to its design, which compiled data from a large Israeli health system rather than enrolling patients in a randomized study with a control group — the gold-standard for medical research.

The findings reflect the changing nature of the pandemic, in which the vast majority of people already have some protection against the virus due to vaccination or prior infection. For younger adults, in particular, that greatly reduces their risks of severe COVID-19 complications. The Centers for Disease Control and Prevention recently estimated that 95% of Americans 16 and older have acquired some level of immunity against the virus.

A spokesman for Pfizer declined to comment on the results, which were published in the New England Journal of Medicine.

The U.S. Food and Drug Administration authorized Paxlovid late last year for adults and children 12 and older who are considered high risk due to conditions like obesity, diabetes and heart disease. More than 42% of U.S. adults are considered obese, representing 138 million Americans, according to the CDC.

At the time of the FDA decision there were no options for treating COVID-19 at home, and Paxlovid was considered critical to curbing hospitalizations and deaths during the pandemic’s second winter surge. The drug’s results were also far stronger than a competing pill from Merck.

The FDA made its decision based on a Pfizer study in high-risk patients who hadn’t been vaccinated or treated for prior COVID-19 infection.

Pfizer reported earlier this summer that a separate study of Paxlovid in healthy adults — vaccinated and unvaccinated — failed to show a significant benefit. Those results have not yet been published in a medical journal.

More than 3.9 million prescriptions for Paxlovid have been filled since the drug was authorized, according to federal records. A treatment course is three pills twice a day for five days.

Biden administration officials have been working for months to increase use of Paxlovid, opening thousands of sites where patients who test positive can fill a prescription. Last month, U.S. officials further expanded access by allowing pharmacists to prescribe the drug.

The White House recently signaled that it may soon stop purchasing COVID-19 vaccines, drugs and tests, shifting responsibility to the private insurance market. Under that scenario, insurers could set new criteria for when they would pay for patients to receive Paxlovid.

Additional reporting by The Associated Press.

Source: newsy.com

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W.H.O. Declares Monkeypox A Global Emergency

By Maura Sirianni
July 23, 2022

New York City is the current epicenter of the monkeypox outbreak in the U.S., with 778 cases.

The World Health Organization declared monkeypox an international emergency.

This is the first time in history a director-general has declared an emergency without a clear recommendation from the emergency committee of the W.H.O.

Here in the U.S., health officials have been working on a strategic deployment of vaccines.

As cases climb globally, experts fear the window for containment is shrinking.

The rare disease gained a foothold in Europe and North America. Now, W.H.O. Director-General Dr. Tedros Adhanom Ghebreyesus said the disease is now appearing in regions where it hasn’t before.

“We have an outbreak that has spread around the world rapidly through new modes of transmission, about which we understand too little,” said Dr. Tedros.

Dr. Tedros made the decision Saturday, saying he acted as “a tiebreaker,” despite a lack of consensus among experts on the agency’s emergency committee.

The W.H.O. reports that monkeypox has now spread to more than 70 countries. In the U.S., according to the latest CDC data, there are 2,891 confirmed cases of monkeypox. Currently, New York, California, Florida, Illinois, and Georgia are among the states reporting the highest number of cases.

“The good news about monkeypox is, if there is any at all, is that it is a familiar threat. We have tests and we have vaccines,” said California Assembly Speaker Anthony Rendon.

This week in San Francisco protestors expressed frustration with the state’s slow response to handling the disease and demanded additional vaccines.

New York City is the current epicenter of the monkeypox outbreak in the U.S., with 778 cases. Health officials there say 17,000 monkeypox vaccine appointments were booked within 30 minutes Friday evening. As they work to meet the demand, state health officials say there may not be enough vials to accommodate everyone who is eligible for a shot.

“I want you to know that we are doing everything we can to get the vaccine to residents who have the highest likelihood of exposure and where we have seen monkeypox is present,” said Dr. Mary Bassett, health commissioner of the New York State Department of Health.

According to a study published this week in the New England Journal of Medicine, 95% of monkeypox cases have been transmitted through sexual activity; the cases are associated with gay and bisexual men, which Dr. Tedros says they are a group that remains most at-risk for contracting and spreading the disease.

“For the moment, this is an outbreak that is concentrated among men who have sex with men, especially those with multiple sexual partners,” said Dr. Tedros.

Despite this, Dr. Tedros says the disease could spill over into other communities. Symptoms to look out for: monkeypox rashes, swollen lymph nodes, a headache, fatigue, and a sore throat. Experts say the good news is that the disease can be stopped if all countries work to deliver information and vaccines to affected communities.

“With the tools we have right now, we can stop transmission and bring this outbreak under control,” said Dr. Tedros.

A global emergency doesn’t necessarily mean a disease is particularly deadly or transmissible.

Similar declarations were made for the Zika virus in 2016 in Latin America and the Ebola outbreak in West Africa in 2014.

The W.H.O. said earlier this month, COVID-19 remains a global emergency, nearly 2-and-a-half years after it was first declared.

Source: newsy.com

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Pfizer Vaccine Is Highly Effective Against Variants, Studies Find

The second new study, which was published in The Lancet, was conducted by researchers at the Israel Ministry of Health and Pfizer. It is based on more than 230,000 coronavirus infections that occurred in Israel between Jan. 24 and April 3. During that period, B.1.1.7 accounted for nearly 95 percent of all coronavirus cases in the country, which has vaccinated more than half of its population.

The researchers found that the vaccine was more than 95 percent effective at protecting against coronavirus infection, hospitalization and death among fully vaccinated people 16 and older. It also worked well in older adults. Among those 85 or older, the vaccine was more than 94 percent effective at protecting against infection, hospitalization and death.

As the percentage of fully vaccinated people in each age group grew, the incidence of coronavirus infections in that cohort fell, the researchers found. The declines in infection rates matched the timing of increasing vaccine coverage in each age group better than the start of a nationwide lockdown. The results suggest that Israel’s rapid pace of vaccination has been responsible for the decline in infections in the country.

“I’m just really happy to see this data that in the real world these vaccines are having such an amazing impact on curtailing infection and disease,” said Akiko Iwasaki, an immunologist at Yale University.

Both studies also reported that two doses of the vaccine provided significantly more protection than one dose did. In the Israel study, for example, one dose of the vaccine was 77 percent effective against death, while two doses were 96.7 percent effective.

“It absolutely emphasizes the need for the second dose,” said Dr. Kathleen Neuzil, who directs the Center for Vaccine Development and Global Health at the University of Maryland School of Medicine.

Together, the studies suggest that even with the new variants, vaccination remains a plausible path out of the pandemic, experts said. “If we can get vaccines to the world and get coverage up,” Dr. Neuzil said, “I believe we can get on top of this and we can get on top of the emergence of new variants.”

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No Pregnancy Risk Found From 2 Covid-19 Vaccines, Preliminary Research Shows

In an early analysis of coronavirus vaccine safety data, researchers at the Centers for Disease Control and Prevention have found no evidence that the Pfizer-BioNTech or Moderna vaccines pose serious risks during pregnancy.

The findings are preliminary and cover just the first 11 weeks of the U.S. vaccination program. But the study, which included self-reported data on more than 35,000 people who received one of the vaccines during or shortly before pregnancy, is the largest yet on the safety of the coronavirus vaccines in pregnant people.

During the clinical trials of the vaccines, pregnant women were excluded. That left patients, doctors and experts unsure whether the shots were safe to administer during pregnancy.

“There’s a lot of anxiety about whether it’s safe and whether it would work and what to expect as far as side effects,” said Dr. Stephanie Gaw, a maternal-fetal medicine specialist at the University of California, San Francisco.

are more likely to become seriously ill, and more likely to die, than nonpregnant women with symptoms.

Because of those risks, the C.D.C. has recommended that coronavirus vaccines be made available to pregnant women, though it also suggests that they consult with their doctors when making a decision about vaccination.

The new study, which was published on Wednesday in The New England Journal of Medicine, is based largely on self-reported data from V-safe, the C.D.C.’s coronavirus vaccine safety monitoring system. Participants in the program use a smartphone app to complete regular surveys about their health, and any side effects they might be experiencing, after receiving a Covid-19 vaccine.

an immediate pause in the use of Johnson & Johnson’s single-dose Covid-19 vaccine after six recipients in the United States developed a rare disorder involving blood clots within one to three weeks of vaccination.

All 50 states, Washington, D.C. and Puerto Rico temporarily halted or recommended providers pause the use of the vaccine. The U.S. military, federally run vaccination sites and a host of private companies, including CVS, Walgreens, Rite Aid, Walmart and Publix, also paused the injections.

Fewer than one in a million Johnson & Johnson vaccinations are now under investigation. If there is indeed a risk of blood clots from the vaccine — which has yet to be determined — that risk is extremely low. The risk of getting Covid-19 in the United States is far higher.

The pause could complicate the nation’s vaccination efforts at a time when many states are confronting a surge in new cases and seeking to address vaccine hesitancy.

Johnson & Johnson had also decided to delay the rollout of its vaccine in Europe amid concerns over rare blood clots, but it later decided to resume its campaign after the European Union’s drug regulator said a warning label should be added. South Africa, devastated by a more contagious virus variant that emerged there, suspended use of the vaccine, and Australia announced it would not purchase any doses.

Two reports published on Friday in a leading medical journal help to explain how AstraZeneca’s Covid vaccine can, in rare cases, cause serious and sometimes fatal blood clots.

Scientific teams from Germany and Norway found that people who developed the clots after vaccination had produced antibodies that activated their platelets, a blood component involved in clotting. The new reports add extensive details to what the researchers have already stated publicly about the blood disorder.

Why the rare reaction occurred is not known. Younger people appear more susceptible than older ones, but researchers say no pre-existing health conditions are known to predispose people to the problem, so there is no way to tell if an individual is at high risk.

Reports of the clots have already led a number of countries to limit AstraZeneca’s vaccine to older people, or to stop using it entirely. The cases have dealt a crushing blow to global efforts to halt the pandemic, because the AstraZeneca shot — easy to store and relatively cheap — has been a mainstay of vaccination programs in more than 100 countries.

statement on its website, AstraZeneca said it was “actively collaborating with the regulators to implement these changes to the product information and is already working to understand the individual cases, epidemiology and possible mechanisms that could explain these extremely rare events.”

The two new reports were published by The New England Journal of Medicine. One from Germany describes 11 patients, including nine women ages 22 to 49. Five to 16 days after vaccination, they were found to have one or more clots. Nine had cerebral venous thrombosis, a clot blocking a vein that drains blood from the brain. Some had clots in their lungs, abdomen or other areas. Six of the 11 died, one from a brain hemorrhage.

One patient had pre-existing conditions that affected clotting, but during a news briefing on Friday, Dr. Andreas Greinacher, an author of the report, said those conditions most likely played only a minor role in the disorder that occurred after vaccination.

second report, from Norway, described five patients, one male and four female health care workers ages 32 to 54, who had clots and bleeding from seven to 10 days after receiving the AstraZeneca vaccine. Four had severe clots in the brain, and three died. Severe headaches were among their early symptoms. Like the German patients, all had high levels of antibodies that could activate platelets.

The team from Norway also recommended treatment with intravenous immune globulin. The researchers said the disorder was rare, but “a new phenomenon with devastating effects for otherwise healthy young adults,” and they suggested that it may be more common than previous studies of the AstraZeneca vaccine had indicated.

On Friday, European regulators also said they were reviewing reports of a few blood clot cases that occurred in people who had received the Johnson and Johnson vaccine. In the United States, federal agencies are investigating reports of a different type of unusual blood disorder involving a precipitous drop in platelets that emerged in a few people who had received either the Pfizer-BioNTech or Moderna vaccines.

Benjamin Mueller and Melissa Eddy contributed.