Month: November 2021

A panel of U.S. health advisers on Tuesday narrowly backed a closely watched COVID-19 pill from Merck, setting the stage for a likely authorization of the first drug that Americans could take at home to treat the coronavirus. 

A Food and Drug Administration panel voted 13-10 that the drug’s benefits outweigh its risks, including potential birth defects if used during pregnancy. 

The recommendation came after hours of debate about the drug’s modest benefits and potential safety issues. Experts backing the treatment stressed that it should not be used by anyone who is pregnant and called on the FDA to recommend extra precautions before the drug is prescribed, including pregnancy tests for women of child-bearing age. 

The vote specifically backed the drug for adults with mild-to-moderate COVID-19 who face the greatest risks, including older people and those with conditions like obesity and asthma. Most experts also said the drug shouldn’t be used in vaccinated patients, who weren’t part of the study and haven’t been shown to benefit. 

The FDA isn’t bound by the panel’s recommendation and is expected to make its own decision before year’s end. The pill is already authorized in the United Kingdom. 

The drug, molnupiravir, could provide a much-needed weapon against the virus as colder weather pushes case counts higher and U.S. officials brace for the arrival of the new omicron variant.

Merck hasn’t specifically tested its drug against the new variant but said it should have some potency based on its effectiveness against other strains of the coronavirus. 

But that uncertainty frustrated many panelists as they grappled with whether to back the treatment for millions of Americans. 

“With no data saying it works with new variants, I really think we need to be careful about saying that this is the way to go,” said Dr. David Hardy of Charles Drew University School of Medicine and Science, who ultimately voted to back the drug. 

Effectiveness, dangers

The panel’s narrow-but-positive recommendation came despite new data from Merck that paint a less compelling picture of the drug’s effectiveness than just a few weeks earlier. 

Last week, Merck said final study results showed molnupiravir reduced hospitalization and death by 30% among adults infected with the coronavirus, when compared with adults taking a placebo. That effect was significantly less than the 50% reduction it first announced based on incomplete results. 

That smaller-than-expected benefit amplified experts’ concerns about the drug’s toxicity for fetuses. 

FDA scientists told the panelists earlier Tuesday that company studies in rats showed the drug caused toxicity and birth defects when given at very high doses. Taken together, FDA staffers concluded the data “suggest that molnupiravir may cause fetal harm when administered to pregnant individuals.” 

FDA is weighing a blanket restriction against any use in pregnant women or allowing it in rare cases. Some panelists said the option should be left open for pregnant mothers who have high-risk COVID-19 and may have few other treatment options. 

Dr. Janet Cragan, who backed the drug, said that even with tight restrictions, some pregnant women would inevitably take the drug.

“I don’t think you can ethically tell a woman with COVID-19 that she can’t have the drug if she’s decided that’s what she needs,” a panel member and staffer with the Centers for Disease Control and Prevention. “I think the final decision has to come down to the individual woman and her provider.”

Merck’s drug uses a novel approach to fight COVID-19: It inserts tiny errors into the coronavirus’ genetic code to stop it from reproducing. That genetic effect has raised concerns that the drug could spur more virulent strains of the virus. But FDA regulators said Tuesday that risk is theoretical and seems unlikely. 

Pfizer drug

While Merck and its partner Ridgeback Biotherapeutics were the first to submit their COVID-19 pill to the FDA, rival drugmaker Pfizer is close behind with its own pill under review. 

Pfizer’s drug is part of a decades-old family of antiviral pills known as protease inhibitors, a standard treatment for HIV and hepatitis C. They work differently than Merck’s pill and haven’t been linked to the kind of mutation concerns raised with Merck’s drug. 

Pfizer said this week that its drug shouldn’t be affected by the omicron variant’s mutations. 

The U.S. government has agreed to purchase 10 million treatment courses of Pfizer’s drug, if it’s authorized. That’s more than three times the government’s purchase agreement with Merck for 3.1 million courses of molnupiravir. 

Both drugs require patients to take multiple pills, twice a day for five days. 

 
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Herd immunity is when a significant portion of a community is immune to an infectious disease, making it harder for the disease to spread.
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To make Black history more accessible, an Oakland, California man designed his own augmented reality app. Matt Dibble has the story.
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Japan and France confirmed their first cases of the new variant of the coronavirus on Tuesday as countries around the world scrambled to close their doors or find ways to limit its spread while scientists study how damaging it might be.

The World Health Organization has warned that the global risk from the omicron variant is “very high” based on early evidence, saying it could lead to surges with “severe consequences.”

French authorities on Tuesday confirmed the first case of the omicron variant in the French island territory of Reunion in the Indian Ocean. Patrick Mavingui, a microbiologist at the island’s research clinic for infectious diseases, said the person who has tested positive for the new variant is a 53-year-old man who had traveled to Mozambique and stopped in South Africa before returning to Reunion.

The man was placed in quarantine. He has “muscle pain and fatigue,” Mavingui said, according to public television Reunion 1ere.

Japan on Tuesday confirmed its first case in a visitor who recently arrived from Namibia, a day after banning all foreign visitors as an emergency precaution against the variant. A government spokesperson said the patient, a man in his 30s, tested positive upon arrival at Narita airport on Sunday and was isolated and is being treated at a hospital.

Cambodia barred entry to travelers from 10 African countries, citing the threat from the omicron variant. The move came just two weeks after Cambodia reopened its borders to fully vaccinated travelers on Nov. 15.

The new version was first identified days ago by researchers in South Africa.

WHO said there are “considerable uncertainties” about the omicron variant. But it said preliminary evidence raises the possibility that the variant has mutations that could help it both evade an immune-system response and boost its ability to spread from one person to another.

The WHO stressed that while scientists are hunting evidence to better understand this variant, countries should accelerate vaccinations as quickly as possible.

Despite the global worry, doctors in South Africa are reporting patients are suffering mostly mild symptoms so far. But they warn that it is early. Also, most of the new cases are in people in their 20s and 30s, who generally do not get as sick from COVID-19 as older patients. 
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Newly named Twitter CEO Parag Agrawal has emerged from behind the scenes to take over one of Silicon Valley’s highest-profile and politically volatile jobs. 

But his prior lack of name recognition, coupled with a solid technical background, appears to be what some big company backers were looking for to lead Twitter out of its current morass. 

A 37-year-old immigrant from India, Agrawal comes from outside the ranks of celebrity CEOs, which include the man he’s replacing, Jack Dorsey, Facebook’s Mark Zuckerberg or SpaceX and Tesla’s Elon Musk. Those brand-name company founders and leaders have often been in the news — and on Twitter — for exploits beyond the day-to-day running of their companies.

Having served as Twitter’s chief technology officer for the past four years, Agrawal’s appointment was seen by Wall Street as a choice of someone who will focus on ushering Twitter into what’s widely seen as the internet’s next era — the metaverse. 

Agrawal is a “‘safe’ pick who should be looked upon as favorably by investors,” wrote CFRA Research analyst Angelo Zino, who noted that Twitter shareholder Elliott Management Corp. had pressured Dorsey to step down. 

Elliott released a statement Monday saying Agrawal and new board chairman Bret Taylor were the “right leaders for Twitter at this pivotal moment for the company.” Taylor is president and chief operating officer of the business software company Salesforce. 

Agrawal joins a growing cadre of Indian American CEOs of large tech companies, including Sundar Pichai of Google parent Alphabet, Microsoft’s Satya Nadella and IBM’s Arvind Krishna. 

He joined San Francisco-based Twitter in 2011, when it had just 1,000 employees, and has been its chief technical officer since 2017. At the end of last year, the company had a workforce of 5,500. 

Agrawal previously worked at Microsoft, Yahoo and AT&T in research roles. At Twitter, he’s worked on machine learning, revenue and consumer engineering and helping with audience growth. He studied at Stanford and the Indian Institute of Technology, Bombay. 

While Twitter has high-profile users like politicians and celebrities and is a favorite of journalists, its user base lags far behind old rivals like Facebook and YouTube and newer ones like TikTok. It has just over 200 million daily active users, a common industry metric.

As CEO, Agrawal will have to step beyond the technical details and deal with the social and political issues Twitter and social media are struggling with. Those include misinformation, abuse and effects on mental health. 

Agrawal got a fast introduction to life as CEO of a high-profile company that’s one of the central platforms for political speech online. Conservatives quickly unearthed a tweet he sent in 2010 that read “If they are not gonna make a distinction between muslims and extremists, then why should I distinguish between white people and racists.”

As some Twitter users pointed out, the 11-year-old tweet was quoting a segment on “The Daily Show,” which was referencing the firing of Juan Williams, who made a comment about being nervous about Muslims on an airplane.

Twitter did not immediately respond to a message for comment on the tweet. 
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U.S. President Joe Biden says a highly transmissible COVID-19 variant, dubbed omicron, is a cause for “concern, not panic” and defended his much-criticized decision to restrict travel from the southern African region, where it was first reported. VOA’s Anita Powell reports from the White House.

Produced by: Barry Unger
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Twitter founder and CEO Jack Dorsey is stepping down as the company’s leader.  

In a news release, Twitter said Dorsey would be replaced by Parag Agrawal, who has been the company’s chief technology officer since 2017. The move is effective immediately.  

“I’ve decided to leave Twitter because I believe the company is ready to move on from its founders. My trust in Parag as Twitter’s CEO is deep. His work over the past 10 years has been transformational. I’m deeply grateful for his skill, heart, and soul. It’s his time to lead,” Dorsey said in a statement.

Dorsey made his resignation official in a tweet Monday and attached a letter with an explanation of why he was leaving.  

“not sure anyone has heard but, I resigned from Twitter,” he wrote.

On Sunday, Dorsey tweeted “I love twitter.”

Dorsey, 45, founded the microblogging platform in 2006 and was CEO until 2008 when he was pushed aside only to return to the top spot in 2015.  

Last year, Elliott Management, a major stakeholder in the company, wanted Dorsey to choose between being CEO of Twitter or CEO of Square, a digital payment company he founded.  

Twitter’s stock rose on the news, but trading of the shares was suspended.

Some information in this report came from Reuters.
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The World Health Organization says renewed efforts to prevent the spread of the coronavirus is needed as scientists scramble to determine the risks posed by the new omicron variant. Low vaccine rates combined with public fatigue over safety measures are putting more people in Africa at risk.

Experts say it’s no surprise a new variant of the coronavirus has been discovered.

Fewer than 8 percent of Africans are vaccinated against COVID-19, creating an environment for the illness to spread and mutate.

Dr. Mary Stephen is a technical officer for the World Health Organization’s Africa office. 

She said in the absence of vaccines, the public needs encouragement to uphold other measures to reduce the spread and save lives.

“We cannot be tired; we have to continue to make sure we are complying with wearing of our face masks, keeping our distance away, avoiding unnecessary mass gatherings, ensuring good hand hygiene, so that it’s another layer of protection in addition to the vaccination,” she said.

South African scientists detected the omicron variant last week.

Research is under way to determine how transmittable it is and its reaction to vaccines.

Amid uncertainty, Britain, the United States and European Union reacted by imposing travel bans to southern Africa.

Stephen, however, said the variant has already crossed continents and that halting flights to African countries that have long enforced testing for travelers is the wrong response. 

“The world should react to them with solidarity. The solution is not about banning travel but our ability to identify these cases, identify the potential risks, mitigate the risks, while we are still facilitating international travel because we have seen the devastating effects that COVID had on the economy,” she said.

Jeremiah Tshukudu is all too familiar with the economic toll of the pandemic.

The 45-year-old Uber driver said two of his cars were repossessed last year because he could no longer afford the payments during lockdown.

Tshukudu said he fears he’s about to take another financial hit with the new variant.

“I see us like losing close to let’s say 50% of what we’ve been earning recently. Relying on Uber, business was down, that means I wouldn’t be able to provide for the family,” he said.

Despite the pandemic’s impact on him, Tshukudu said he’s still hesitant about getting vaccinated.

With the threat of a new variant, experts are hoping people like him will reconsider.

Dr. Michelle Groome is with South Africa’s National Institute for Communicable Diseases. 

“Hopefully, you know, with some concern over coming fourth wave, hopefully, you know, those that were on the fence may actually go and vaccinate,” she said.

More than 3,200 people in South Africa tested positive for COVID-19 on Saturday, a marked increase from the day before.

The government is campaigning for more people to get vaccinated and even offering grocery vouchers to those who get their shot.

Government data show that at least 41 percent of South African adults have now been vaccinated.
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Zimbabwe’s government says the country is very prepared to handle the new COVID-19 variant – omicron – first reported in neighboring South Africa. The World Health Organization says a fourth wave of the pandemic is most likely to hit Africa.

Zimbabwe’s Vice President Constantino Chiwenga – who doubles as the country’s health minister – has asked the nation not to be concerned about omicron.

“The country should not panic because we are very prepared. The ramping up of our vaccination program in the past month has seen marked increase in the vaccination uptake. That is the prevention which we are going to have for our people if any other variant comes. At least when your body is protected it is much better than when you are found naked,” said the vice president.

Zimbabwe has fully inoculated about 2.8 million people since February, when it began its vaccination program to contain the COVID-19 pandemic. The government has a target of vaccinating at least 10 million Zimbabweans — or 60% of the population — by the end of the year, a figure which might be difficult to reach given the scarcity of resources and short time left.

Itai Rusike, head of the nonprofit Community Working Group on Health, said Zimbabweans should panic about the new variant – initially named B.1.1.529 – since the country shares porous borders with South Africa and Botswana.

“And this new variant is coming at a time when the festive season is upon us. A whole lot of Zimbabweans, they use undesignated entry points. That poses a serious health challenge as they would not be properly screened and monitored as they come back to the country. What we want to encourage the government of Zimbabwe, is for them to strengthen their surveillance and monitoring system especially the land borders and make sure that the screening and monitoring at the entry points is also strengthened,” said Rusike.

Meanwhile, Humphrey Karamagi, a medical officer at the World Health Organization Regional Office for Africa, said on the WHO Twitter account that a fourth wave of COVID-19 is likely to hit the continent.

“A fourth wave in Africa is almost a certainty, as long as we have these factors in play, which is new variants coming up and the fact that people can be reinfected. And also, if we are getting new population who may not have been exposed. We would then have subsequent waves. Vaccination helps a lot in terms of reducing the severity of the disease [and] also reducing the risk of infection. The vaccine is not a magic bullet. So the vaccine is to work together with the public health measures to reduce the potential and risks of subsequent waves,” said Karamagi.

The WHO says COVID-19 has infected about 6.1 million people in Africa and claimed 152,113 lives. The world health body also says more than 227 million vaccine doses have been administered in Africa.
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Dutch health officials said Sunday 13 people who recently arrived in the Netherlands on flights from South Africa have tested positive for the new omicron variant of the coronavirus.

The passengers were part of a group of 61 who tested positive following their arrival in Amsterdam on Friday.

The announcement came shortly after Australia said two cases of the variant were discovered in passengers who recently arrived in Sydney.

Omicron is the fifth WHO-designated variant of concern. It was first detected recently in South Africa, which has seen an exponential rise in COVID-19 cases.

There are about 30 mutations on the coronavirus’ spike protein, and scientists worry that some of them could make the virus easier to transmit. But scientists do not yet know whether omicron is in fact more transmissible or dangerous.

Cases of the variant have also been discovered in Israel, Hong Kong and several European countries.

Concern over the variant has prompted many countries, including the United States, Canada, Brazil, and European Union nations, to restrict or ban travel from southern African countries.

The South African government has called the travel restrictions “rushed” and raised concerns about the impact on business.

The top U.S. infectious diseases expert, Dr. Anthony Fauci, has said he would not be surprised if the omicron variant were already in the U.S.

On Sunday, Fauci told ABC’s “This Week” program that the omicron variant “appears” to be more transmissible than other variants, but health officials are still not sure if it causes more severe disease.

He said efforts are under way to determine if current COVID-19 vaccines are effective against the new variant and the answer likely will come in the next two weeks.

“I don’t think there’s any possibility that this could completely evade any protection by vaccine. It may diminish it a bit, but that’s the reason why you boost,” Fauci said, referring to booster shots.

In South Africa, roughly 35% of the adult population is vaccinated. Figures are even lower across much of the African continent.

Heath experts have warned vaccine inequality would create a breeding ground for virus mutations.

Information for this report came from The Associated Press and Reuters.
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Australia’s government said Sunday it will introduce legislation to unmask online trolls and hold social media giants like Facebook and Twitter responsible for identifying them.

Prime Minister Scott Morrison, whose conservative coalition government faces an election in the first half of 2022, said the law would protect Australians from online abuse and harassment.

“The online world should not be a wild west where bots and bigots and trolls and others can just anonymously go around and harm people and hurt people, harass them and bully them and sledge them,” Morrison told reporters.

“That is not what can happen in the real world, and there is no case for it to be able to be happening in the digital world.”

Attorney General Michaelia Cash said the legislation, reportedly to be introduced to parliament by early 2022, is needed to clarify that the social media platforms, and not the users, were responsible for defamatory comments by other people.

Confusion had been sown by a High Court ruling in September that found Australian media, as users managing their own pages on a social network, could be held liable for defamatory third-party comments posted on their pages, Cash said.

Under the planned Australian legislation, the social media companies themselves would be responsible for such defamatory content, not the users, she said.

It would also aim to stop people making defamatory comments without being identified, she said.

“You should not be able to use the cloak of online anonymity to spread your vile, defamatory comments,” the attorney general said.

The legislation would demand that social media platforms have a nominated entity based in Australia, she said.

The platforms could defend themselves from being sued as the publisher of defamatory comment only if they complied with the new legislation’s demands to have a complaints system in place that could provide the details of the person making the comment, if necessary, Cash said.

People would also be able to apply to the High Court for an “information disclosure order” demanding a social media service provide details “to unmask the troll,” the attorney general said.

In some cases, she said, the “troll” may be asked to take down the comment, which could end the matter if the other side is satisfied.

Australia’s opposition leader Anthony Albanese said he would support a safer online environment for everyone.

But he said the government had failed to propose action to stop the spread of misinformation on social media and accused some of the government’s own members of spreading misinformation about COVID and vaccinations.
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The new potentially more contagious omicron variant of the coronavirus popped up in more European countries on Saturday, just days after being identified in South Africa, leaving governments around the world scrambling to stop the spread.

The U.K. on Saturday tightened its rules on mask-wearing and on testing of international arrivals after finding two cases. New cases were confirmed Saturday in Germany and Italy, with Belgium, Israel and Hong Kong also reporting that the variant has been found in travelers.

In the U.S., Dr. Anthony Fauci, the government’s top infectious diseases expert, said he would not be surprised if the omicron variant was already in the United States, too.

“We have not detected it yet, but when you have a virus that is showing this degree of transmissibility … it almost invariably is ultimately going to go essentially all over,” Fauci said on NBC television.

Because of fears that the new variant has the potential to be more resistant to the protection offered by vaccines, there are growing concerns around the world that the pandemic and associated lockdown restrictions will persist for far longer than hoped.

Nearly two years since the start of the pandemic that has claimed more than 5 million lives around the world, countries are on high alert. Many have already imposed travel restrictions on flights from southern Africa as they seek to buy time to assess whether the omicron variant is more transmissible than the current dominant delta variant.

In Britain, Prime Minister Boris Johnson said it was necessary to take “targeted and precautionary measures” after two people tested positive for the new variant in England.

“Right now this is the responsible course of action to slow down the seeding and the spread of this new variant and to maximize our defenses,” he told a news conference.

Among the measures announced, Johnson said anyone arriving in England must take a PCR test for COVID-19 on the second day after their arrival and self-isolate until they provide a negative test. And if someone tests positive for the omicron variant, then he said their close contacts will have to self-isolate for 10 days regardless of their vaccination status — currently close contacts are exempt from quarantine rules if they are fully vaccinated.

He also said mask-wearing in shops and on public transport will be required and said the independent group of scientists that advises the British government on the rollout of coronavirus vaccines has been asked to accelerate the vaccination program. This could involve widening the booster program to younger age groups, reducing the time period between a second dose and a booster and allowing older children to get a second dose.

“From today we’re going to boost the booster campaign,” he said.

Britain’s Department of Health said the two cases found in the U.K. were linked and involved travel from southern Africa. One of the two new cases was in the southeastern English town of Brentwood, while the other was in the central city of Nottingham. The two confirmed cases are self-isolating with their households while contact tracing and targeted testing takes place.

The British government also added four more countries — Angola, Malawi, Mozambique and Zambia — to the country’s travel red list from Sunday. Six others — Botswana, Eswatini (formerly Swaziland), Lesotho, Namibia, South Africa and Zimbabwe — were added Friday. That means anyone permitted to arrive from those destinations will have to quarantine.

Many countries have slapped restrictions on various southern African countries over the past couple of days, including Australia, Brazil, Canada, the European Union, Iran, Japan, New Zealand, Thailand and the United States, in response to warnings over the transmissibility of the new variant. This goes against the advice of the World Health Organization, which has warned against any overreaction before the variant was thoroughly studied.

Despite the banning of flights, there are mounting concerns that the variant has already been widely seeded around the world.

Italy and Germany were the latest to report confirmed cases of the omicron variant.

An Italian who had traveled to Mozambique on business landed in Rome on Nov. 11 and returned to his home near Naples. He and five family members, including two school-age children, have since tested positive, the Italian news agency LaPresse said. All are isolating in the Naples suburb of Caserta in good condition with light symptoms.

The variant was confirmed by Sacco hospital in Milan, and Italy’s National Health Institute said the man had received two doses of the vaccine. Italy’s health ministry is urging all regions to increase tracing of the virus and sequencing to detect cases of the new variant first identified in South Africa.

In Germany, the Max von Pettenkofer Institute, a Munich-based microbiology center, said the omicron variant was confirmed in two travelers who arrived on a flight from South Africa on Nov. 24. The head of the institute, Oliver Keppler, said that genome sequencing has yet to be completed, but it is “proven without doubt that it is this variant,” German news agency dpa reported.

The Dutch public health institute said the omicron variant was “probably found in a number of the tested persons” who were isolated after arriving Friday in Amsterdam on two flights from South Africa. The institute said in a statement that further sequencing analysis is underway to determine for sure that it is the new variant. The results were expected Sunday. A total of 61 people were tested.

Israel said it detected the new strain in a traveler who had returned from Malawi and was tracing 800 travelers who returned recently from southern African countries. And Australia said early Sunday its scientists were working to determine whether two people who tested positive for COVID after arriving from southern Africa are infected with the omicron variant.

The variant’s swift spread among young people in South Africa has alarmed health professionals even though there was no immediate indication whether the variant causes more severe disease.

Several pharmaceutical firms, including AstraZeneca, Moderna, Novavax and Pfizer, said they have plans in place to adapt their vaccines in light of the emergence of omicron. Pfizer and its partner BioNTech said they expect to be able to tweak their vaccine in around 100 days.

Professor Andrew Pollard, the director of the Oxford Vaccine Group, which developed the AstraZeneca vaccine, expressed cautious optimism that existing vaccines could be effective at preventing serious disease from the omicron variant, noting that most of the mutations appear to be in similar regions as those in other variants.

“At least from a speculative point of view we have some optimism that the vaccine should still work against a new variant for serious disease, but really we need to wait several weeks to have that confirmed,” he told BBC radio.

Some experts said the variant’s emergence illustrated how rich countries’ hoarding of vaccines threatens to prolong the pandemic.

Fewer than 6% of people in Africa have been fully immunized against COVID-19, and millions of health workers and vulnerable populations have yet to receive a single dose. Those conditions can speed up spread of the virus, offering more opportunities for it to evolve into a dangerous variant.

“One of the key factors to emergence of variants may well be low vaccination rates in parts of the world, and the WHO warning that none of us is safe until all of us are safe and should be heeded,” said Peter Openshaw, a professor of experimental medicine at Imperial College London.

U.S. Secretary of State Antony Blinken spoke Saturday with his South African counterpart, Naledi Pandor, and they stressed the importance of working together to help African nations vaccinate their populations, the State Department said in a statement. It said Blinken praised South Africa’s scientists for quickly identifying the omicron variant and the government for its transparency in sharing this information, “which should serve as a model for the world.” 

 
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The United States praised South Africa on Saturday for quickly identifying the latest coronavirus variant, omicron, and sharing this information with the world.

Secretary of State Antony Blinken spoke with South Africa’s international relations and cooperation minister, Naledi Pandor, and they discussed cooperation on vaccinating people in Africa against COVID-19, the State Department said in a statement.

“Secretary Blinken specifically praised South Africa’s scientists for the quick identification of the omicron variant and South Africa’s government for its transparency in sharing this information, which should serve as a model for the world,” the statement said.

First detected in South Africa, the omicron variant of the coronavirus that causes COVID-19, was deemed by the World Health Organization a “variant of concern” on Friday.

Earlier Saturday, Pandor’s office issued a statement saying that the country is being punished for detecting the new variant as more countries rush to enact travel bans and restrictions.

By Saturday, more than a dozen countries had announced temporary travel restrictions on South Africa and other countries in the region after cases were reported in Europe and the Middle East. 
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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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