Day: November 27, 2021

Federal health regulators say an experimental COVID-19 pill from Merck is effective against the virus, but they will seek input from outside experts on risks of birth defects and other potential problems during pregnancy.

The Food and Drug Administration posted its analysis of the pill ahead of a public meeting next week where academic and other experts will weigh in on its safety and effectiveness. The agency isn’t required to follow the group’s advice.

The FDA scientists said their review identified several potential risks, including possible toxicity to developing fetuses and birth defects that were identified in studies of the pill in animals. 

Given those risks the FDA will ask its advisers next Tuesday whether the drug should never be given during pregnancy or whether it could be made available in certain cases.  

Under that scenario, the FDA said the drug would carry warnings about risks during pregnancy, but doctors would still have the option to prescribe it in certain cases where its benefits could outweigh its risks for patients.

Given the safety concerns, FDA said Merck agreed the drug would not be used in children.

Other side effects were mild and rare, with about 2% of patients experiencing diarrhea.

Regulators also noted that Merck collected far less safety data overall on its drug than was gathered for other COVID-19 therapies.

“While the clinical safety data base was small, there were no major safety concerns identified,” FDA reviewers concluded.

Additionally, the FDA flagged a concern that Merck’s drug led to small changes in the coronavirus’ signature spike protein, which it uses to penetrate human cells. 

Theoretically, FDA cautioned, those changes could lead to dangerous new variants.

FDA will ask its independent advisers to discuss all those issues and then vote on whether the drug’s overall benefits outweigh its risks.

All COVID-19 drugs currently authorized by the FDA require an injection or IV and can only be given by health professionals. If authorized, Merck’s drug would be the first that U.S. patients could take at home to ease symptoms and speed recovery. It is already authorized for emergency use in the U.K. 

The meeting marks the first time regulators have publicly reviewed a new drug for COVID-19, reflecting the intense interest and scrutiny of a pill that could be soon used by millions of Americans.
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France is willing to discuss autonomy for the French Caribbean territory of Guadeloupe if it is in the interests of the people who live there, government minister Sebastien Lecornu said.

Guadeloupe and the nearby French island of Martinique have seen several days of protests against COVID-19 measures that have spilled over into violence.

Lecornu, the minister for France’s overseas territories, said in a YouTube video issued late on Friday that certain elected officials in Guadeloupe had raised the question of autonomy, changing its status as an overseas region.

“The government is ready to talk about this. There are no bad debates, as long as those debates serve to resolve the real everyday problems of people in Guadeloupe,” he said.

That was one of a series of initiatives he said the government in Paris would be taking in Guadeloupe, including improving healthcare, infrastructure projects, and a scheme to create jobs for young people.

The French government this week announced that it would be postponing a requirement that public sector workers in Guadeloupe and Martinique get a COVID-19 vaccination.

That had sparked protests, fanning long-standing grievances over living standards and the relationship with Paris.

In Guadeloupe there is a historic mistrust of the French government’s handling of health crises after many people were exposed to toxic pesticides used in banana plantations in the 1970s.

 
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With hunting season under way, wildlife agencies in the northeastern U.S. states of New Hampshire and Vermont have started testing for COVID-19 in white-tailed deer, as antibodies for the virus have been found in deer in other states, according to a government study.

“We collected blood samples this year during the five busiest days of the hunting season,” said Dan Bergeron, the deer biologist with the New Hampshire Fish and Game Department. “We have biologists at biological check stations and collect ages and weights annually. This year, we also had them collect blood samples.”

New Hampshire and Vermont were approached by the U.S. Department of Agriculture’s Animal and Plant Health Inspection Service about testing the white-tailed deer population as part of its national research on the spread of COVID-19 among the species.

Maine is monitoring the tests from other states, but is not actively testing deer for COVID-19.

In its study, released in July, the inspection service tested 481 deer in Illinois, Michigan, New York and Pennsylvania and found COVID-19 antibodies in 33% of the samples.

“We do not know how the deer were exposed” to the virus, the study said. “It’s possible they were exposed through people, the environment, other deer, or another animal species.”

The study said that based on available information, the risk of deer and other animals spreading COVID-19 to people is low. It also said there were no reports of clinical illness in the deer populations surveyed, and that captive deer “experimentally infected” with the virus as part of a USDA Agricultural Research Service study didn’t show clinical signs of illness. 

 
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As the world grapples with the emergence of the new highly transmissible variant of COVID-19, worried scientists in South Africa — where omicron was first identified — are scrambling to combat its lightning spread across the country.

In the space of two weeks, the omicron variant has sent South Africa from a period of low transmission to rapid growth of new confirmed cases. The country’s numbers are still relatively low, with 2,828 new confirmed cases recorded Friday, but omicron’s speed in infecting young South Africans has alarmed health professionals.

“We’re seeing a marked change in the demographic profile of patients with COVID-19,” Rudo Mathivha, head of the intensive care unit at Soweto’s Baragwanath Hospital, told an online press briefing.

“Young people, in their 20s to just over their late 30s, are coming in with moderate to severe disease, some needing intensive care. About 65% are not vaccinated and most of the rest are only half-vaccinated,” said Mathivha. “I’m worried that as the numbers go up, the public health care facilities will become overwhelmed.”

She said urgent preparations are needed to enable public hospitals to cope with a potential large influx of patients needing intensive care.

“We know we have a new variant,” said Mathivha. “The worst-case scenario is that it hits us like delta … we need to have critical care beds ready.”

What looked like a cluster infection among some university students in Pretoria ballooned into hundreds of new cases and then thousands, first in the capital city and then to nearby Johannesburg, South Africa’s largest city.

Studying the surge, scientists identified the new variant that diagnostic tests indicate is likely responsible for as many as 90% of the new cases, according to South Africa’s health officials. Early studies show that it has a reproduction rate of 2 — meaning that every person infected by it is likely to spread it to two other people.

The new variant has a high number of mutations that appear to make it more transmissible and help it evade immune responses. The World Health Organization looked at the data on Friday and named the variant omicron, under its system of using Greek letters, calling it a highly transmissible variant of concern.

“It’s a huge concern. We all are terribly concerned about this virus,” Professor Willem Hanekom, director of the Africa Health Research Institute, told The Associated Press.

“This variant is mostly in Gauteng province, the Johannesburg area of South Africa. But we’ve got clues from diagnostic tests … that suggest that this variant is already all over South Africa,” said Hanekom, who is also co-chair of the South African COVID Variant Research Consortium.

“The scientific reaction from within South Africa is that we need to learn as much as soon as possible. We know precious little,” he said. “For example, we do not know how virulent this virus is, which means how bad is this disease that it causes?”

A key factor is vaccination. The new variant appears to be spreading most quickly among those who are unvaccinated. Currently, only about 40% of adult South Africans are vaccinated, and the number is much lower among those in the 20- to 40-year-old age group.

South Africa has nearly 20 million doses of vaccines — made by Pfizer and Johnson & Johnson — but the numbers of people getting vaccines is about 120,000 per day, far below the government’s target of 300,000 per day.

As scientists try to learn more about omicron, the people of South Africa can take measures to protect themselves against it, said Hanekom.

“This is a unique opportunity. There’s still time for people who did not get vaccinated to go and get the vaccine, and that will provide some protection, we believe, against this infection, especially protection against severe infection, severe disease and death,” he said. “So I would call on people to vaccinate if they can.”

Some ordinary South Africans have more mundane concerns about the new variant.

“We’ve seen increasing numbers of COVID-19, so I’ve been worried about more restrictions,” said Tebogo Letlapa, in Daveyton, eastern Johannesburg. “I’m especially worried about closing of alcohol sales because it’s almost festive season now.” 

 
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Anxious-looking travelers thronged Johannesburg international airport and stood in long queues on Friday, desperate to squeeze onto the last flights to countries that had just shut their doors to South Africa.

Many cut short their holidays, rushing back from safaris and vineyards when Britain announced late Thursday night that all flights from South Africa and its neighbors would be banned the following day.

A flurry of nations — including the United States, Canada and several European countries — have followed suit, concerned about the discovery of a new coronavirus variant, renamed omicron, with several mutations fueling an infection resurgence in South Africa.

United Kingdom citizen Toby Reid, a 24-year-old trader in London, was camping on Cape Town’s Table Mountain with his girlfriend when the ban was announced.

“At about 5:30 a.m., we got up to see if we could catch the sunrise, and at six in the morning, we found out that there was still a possibility to get back,” he told AFP while standing in line for check-in at the Johannesburg airport just hours later.

The couple managed to grab the last two seats on an evening flight to Frankfurt, Germany.

Others who were not so lucky discussed options at ticket counters, eyes widening at proposed prices and convoluted itineraries.

“There should have been more notice,” muttered Christian Good, 50, returning to Devon, England, via Frankfurt with his husband after a beach holiday.

By chance, the pair had originally planned to return on that flight, meaning they would arrive home before mandatory hotel quarantine begins on Sunday — a requirement for citizens returning from “red list” countries.

“It’s ridiculous. We will always be having new variants,” his husband, David, exclaimed, passports in hand.

“South Africa found it, but it’s probably all over the world already,” he told AFP.

The variant has so far been detected in Belgium, Botswana, Israel and Hong Kong.

‘Tired of this’

At the airport, red “canceled” signs flashed next to London-bound flights listed on the departures board.

Other destinations were still in limbo.

A KLM flight to Amsterdam was delayed by several hours after passengers were suddenly compelled to produce negative COVID-19 results.

Rapid PCR tests were offered at the airport, with results guaranteed in two hours, but at a cost of $86, compared with the standard fee of around $52 for results delivered in roughly 12 hours.

An AFP correspondent observed Some African passport holders being told they would not be allowed to fly to Europe.

Earlier, travelers milled around a closed Air France check-in desk, waiting to find out whether an evening flight to Paris would take off as scheduled, just hours after France announced its own ban.

Among them were U.K. citizen Ruth Brown, 25, who lives in South Africa and had planned to return home for the first time since 2019 next week.

Britain kept South Africa on its red list until early October, meaning many of its citizens have been unable to travel back since the pandemic started because of the costly hotel quarantine.

They had only a few weeks of leeway before the status was revoked.

“We are tired of this situation,” said Brown, who spent the morning on the phone trying to change her flight.

“Apparently (this one) is full, but we are trying to see if we can still get seats,” she sighed.

Further down the line, Elke Hahn cradled a toddler.

She had traveled to South Africa with her partner to adopt the child and was desperate to get back to their home in Austria.

The child’s paperwork was only valid for a specific flight route that had since been changed.

“We will have to get another flight, but I don’t know how that will work,” she said. 
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