The Latest: FDA recommends lower-dose Moderna booster shot

This undated image provided by Merck & Co. shows their new antiviral medication. The drugmaker has said its experimental pill for people sick with COVID-19 reduced hospitalizations and deaths.   The U.S. Food and Drug Administration will ask its outside experts to review Merck's pill to treat COVID-19 at a meeting in late November. Regulators announced the November 30 meeting on Thursday, Oct. 14, 2021 signaling they will conduct a detailed review of the drug's safety and effectiveness.   (Merck & Co. via AP)
Caption
This undated image provided by Merck & Co. shows their new antiviral medication. The drugmaker has said its experimental pill for people sick with COVID-19 reduced hospitalizations and deaths. The U.S. Food and Drug Administration will ask its outside experts to review Merck's pill to treat COVID-19 at a meeting in late November. Regulators announced the November 30 meeting on Thursday, Oct. 14, 2021 signaling they will conduct a detailed review of the drug's safety and effectiveness. (Merck & Co. via AP)

Credit: Uncredited

Credit: Uncredited

A panel of U.S. health advisers has endorsed booster shots for Moderna’s COVID-19 vaccine

WASHINGTON — U.S. health advisers said Thursday that some Americans who received Moderna’s COVID-19 vaccine should get a half-dose booster to bolster protection against the virus.

The panel of advisers to the Food and Drug Administration voted unanimously to recommend a booster shot for seniors, adults with other health problems, jobs or living situations that put them at increased risk for COVID-19.

As for the dose, initial Moderna vaccination consists of two 100-microgram shots. But Moderna says a single 50-microgram shot should be enough for a booster.

The FDA will use its advisers’ recommendations in making final decisions for boosters from both companies. Assuming a positive decision, there’s still another hurdle: Next week, a panel convened by the Centers for Disease Control and Prevention will offer more specifics on who should get one.

___

MORE ON THE PANDEMIC:

— FDA panel debates lower-dose Moderna shots for booster

— Africa detecting just 1 in 7 virus cases, says WHO study

— FDA unlikely to rule on Merck's COVID pill before December

— Russia marks pandemic high of infections, deaths

___

See all of AP's pandemic coverage at https://apnews.com/hub/coronavirus-pandemic

___

HERE’S WHAT ELSE IS HAPPENING:

WASHINGTON — The Food and Drug Administration will ask its outside experts to meet in late November to scrutinize Merck’s pill to treat COVID-19.

The Nov. 30 meeting means U.S. regulators likely won’t issue a decision on the drug until December, signaling that the agency will conduct a detailed review of the experimental treatment’s safety and effectiveness. The panelists are likely to vote on whether Merck’s drug should be approved, although the FDA is not required to follow their advice.

Three IV antibody drugs have been authorized since last year but they are expensive, hard to produce and require specialty equipment and health professionals to deliver. If authorized, Merck’s drug, molnupiravir, would be the first that patients could take at home to ease symptoms and speed recovery.

If authorized, Merck’s drug is likely the first — but not the only — pill to treat COVID-19. Pfizer, Roche and Appili Therapeutics are studying similar drugs.

___

WASHINGTON — President Joe Biden spoke out against misinformation surrounding COVID-19 vaccination mandates, encouraging the approximately 66 million unvaccinated Americans to get a shot.

“School board members, religious leaders and doctors across the country are fighting misinformation and educating people about the importance of vaccines,” Biden said.

Speaking at the White House, Biden says employer requirements that their workers be vaccinated are effective. He added: “Vaccination requirements should not be another issue that divides us.”

Biden has issued a federal vaccine mandate on businesses with 100 or more employees that will be implemented in the coming weeks. He says the federal government, as well as businesses and community groups, must “continue to battle the misinformation that’s out there.”

He noted both Southwest Airlines and its pilots’ union dismissed claims that worker action over a pending vaccine mandate at the company was responsible for days of disruption at the airline.

___

LONDON — Britain recorded more than 45,000 daily coronavirus cases on Thursday, with infections particularly prevalent among children.

Government figures on Thursday show 45,066 people tested positive for the coronavirus, the highest since July 20.

Much of the recent increased cases in the U.K. is among children after their return to school. The rollout of vaccines among older children is widely considered slower than hoped.

There’s also been a rise in hospital treatment for COVID-19, though the proportion is lower than previous waves of the pandemic after the rollout of vaccines.

The number of people dying with COVID-19 has held steady in recent weeks, although concerns are rising that the increase in cases will lead to more deaths. Another 157 virus-related deaths were reported Thursday, taking Britain’s confirmed total to 138,237, Europe’s second-highest tally behind Russia.

___

NEW DELHI, India — India has resumed exports of coronavirus vaccines after halting them during a devastating surge in domestic infections in April.

External Affairs Ministry spokesperson Arindam Bagchi says the renewed exports are focused on neighboring countries and will be increased in the coming months once most of India’s eligible adult population is vaccinated.

The vaccines have so far been exported to Nepal, Bangladesh, Iran and Myanmar, Bagchi says. Before halting exports, India donated or sold 66 million vaccine doses to nearly 100 countries.

A country of 1.4 billion people, India has administered more than 960 million vaccine doses. It has given at least one dose to nearly 70% of the eligible adult population.

___

HELSINKI — The office of the Finnish President Sauli Niinsto says he is self-isolating as a precaution after he may have been exposed to coronavirus following a meeting with a Latvian colleague in Sweden.

On Wednesday, Niinisto held a breakfast meeting during a Holocaust conference in the Swedish city of Malmo with Latvian President Egils Levits, who later tested positive for the coronavirus.

___

CAIRO — Egypt is experiencing a growing number of daily coronavirus cases as it struggles to vaccinate a greater proportion of its population.

Daily new infections remain below 1,000 but the country still hasn’t achieved a vaccination rate of 10%.The rising case numbers come as the authorities deal with a case of thousands of unused vaccine doses that were recently found dumped into canal.

On Wednesday, Egypt’s Health and Population Minister Hala Zayed told a cabinet meeting that over eight million out of a population of more than 100 million have been fully inoculated. Another 15 million have received their first dose. She said that her ministry is working on increasing the number of vaccination centers nationwide.

In recent weeks, the vaccination campaign has been targeting millions of Egypt’s state functionaries, university faculty and students as well as teachers and school workers.

On Wednesday, 861 confirmed cases and 41 confirmed deaths were reported. Egypt has recorded a total of nearly 315,000 cases and more than 17,800 deaths. However, the actual tally is believed to be much higher, along with elsewhere around the globe.

___

LONDON — The European Medicines Agency has started an expedited licensing process for an antibody combination drug aimed at preventing the coronavirus, made by AstraZeneca.

In a statement on Thursday, the EU drug regulator said it had started reviewing preliminary laboratory and clinical research data for Evusheld, a combination of the two monoclonal antibodies tixagevimab and cilgavimab. The two drugs attach to different parts of the coronavirus spike protein and are intended to stop the virus from infecting the body’s cells.

Last week, AstraZeneca asked the U.S. Food and Drug Administration to grant the drug an emergency-use listing. If approved, it would be the first such drug given the green light for preventing COVID-19. It likely would be limited to people with weaker immune systems who don’t get enough protection from vaccination alone.

Late-stage research showed AstraZeneca’s antibody combination reduced the risk of developing COVID-19 symptoms by 77% in people who had suppressed immune systems due to cancer, lupus and other health conditions.

___

BEIJING — China’s Foreign Ministry has warned against what it calls possible “political manipulation” of a renewed probe by the World Health Organization into the origins of the coronavirus.

Foreign Ministry spoksperson Zhao Lijian said China would “continue to support and participate in global scientific tracing and firmly oppose any forms of political manipulation.”

The WHO on Wednesday released a proposed list of 25 experts to advise it on next steps in the search for the virus’ origins after its earlier efforts were attacked for going easy on China.

The first human cases of coronavirus infections were detected in central China in late 2019. Beijing was accused of withholding raw data on early cases during a visit by a WHO team in February.

The findings of the original WHO team were inconclusive, and the experts released a report saying it was “extremely unlikely” the coronavirus leaked from a Wuhan lab. That prompted criticism from outside scientists that the theory had not been properly vetted.

___

BUDAPEST, Hungary — Hungary recorded its highest daily number of new COVID-19 cases in five months Thursday amid a spike in coronavirus deaths and hospitalizations.

Officials reported 1,141 new cases, the highest daily total since May 14. The increase pushed the number of cases so far this week to a 37% jump over the same period last week. The country of nearly 10 million has 742 hospitalized COVID-19 patients, the highest number since early June.

Pandemic containment measures in Hungary have been largely repealed since early July, and masks are not required in any public areas.

On Monday, the Hungarian Academy of Sciences recommended that masks be worn in enclosed areas, at events and on public transportation in order to “curb the fourth wave of the COVID-19 pandemic.”

As of Thursday, 66.6% of Hungarian adults were fully vaccinated, below the European Union average of 74.7%, according to the European Center for Disease Prevention and Control.

___

LONDON — As coronavirus vaccines trickle into some of the poorest countries in Asia, Africa and the Middle East, data suggest some women are consistently missing out.

Experts fear women in Africa may be the least vaccinated population globally, thanks in large part to widespread misinformation and vaccine skepticism across the continent.

But vaccine access issues and gender inequality reach far beyond Africa, with women in impoverished communities worldwide facing obstacles including cultural prejudices, lack of technology, and vaccine prioritization lists that didn’t include them.

And while global data by gender in vaccine distribution is lacking in many places, officials agree that women are clearly being left behind men in some places, and that the issue must be addressed for the world to move past the pandemic.

Sarah Hawkes, who runs a global tracker of coronavirus information by sex at University College London, noted that Pakistan and other countries gave initial vaccine priority to groups such as military personnel and migrant workers, likely contributing to continued gender gaps.

___

MOSCOW — Russia on Thursday recorded the highest daily numbers of coronavirus infections and deaths since the start of the pandemic, a rapidly surging toll that has severely strained the nation’s health care system.

The government’s coronavirus task force reported 31,299 new confirmed coronavirus cases and 986 deaths in the last 24 hours.

The country has repeatedly marked record daily death tolls over the past few weeks as infections surged amid a slow vaccination rate and lax enforcement of measures to protect against the coronavirus.

Prime Minister Mikhail Mishustin said Tuesday that about 43 million Russians, or just about 29% of the country’s nearly 146 million people, were fully vaccinated.

Russian President Vladimir Putin has emphasized the need to speed up the vaccination rate, but he also has cautioned against forcing people to get vaccine shots.

___

President Joe Biden delivers an update on the COVID-19 response and vaccination program, in the South Court Auditorium on the White House campus, Thursday, Oct. 14, 2021, in Washington. (AP Photo/Evan Vucci)
Caption
President Joe Biden delivers an update on the COVID-19 response and vaccination program, in the South Court Auditorium on the White House campus, Thursday, Oct. 14, 2021, in Washington. (AP Photo/Evan Vucci)

Credit: Evan Vucci

Credit: Evan Vucci

A woman speaks on a video call next to the National COVID Memorial Wall in London, Thursday, Oct. 14, 2021. (AP Photo/Matt Dunham)
Caption
A woman speaks on a video call next to the National COVID Memorial Wall in London, Thursday, Oct. 14, 2021. (AP Photo/Matt Dunham)

Credit: Matt Dunham

Credit: Matt Dunham

FILE - This file Tuesday, April 20, 2021 file photo shows an exterior view of the European Medicines Agency, EMA, in Amsterdam, Netherlands. The European Medicines Agency said on Tuesday, Oct. 4 the booster doses “may be considered at least 6 months after the second dose for people aged 18 years and older.” The agency also said it supports giving a third dose of either the Pfizer-BioNTech or the Moderna vaccine to people with severely weakened immune systems at least 28 days after their second shot.(AP Photo/Peter Dejong, FILE)
Caption
FILE - This file Tuesday, April 20, 2021 file photo shows an exterior view of the European Medicines Agency, EMA, in Amsterdam, Netherlands. The European Medicines Agency said on Tuesday, Oct. 4 the booster doses “may be considered at least 6 months after the second dose for people aged 18 years and older.” The agency also said it supports giving a third dose of either the Pfizer-BioNTech or the Moderna vaccine to people with severely weakened immune systems at least 28 days after their second shot.(AP Photo/Peter Dejong, FILE)

Credit: Peter Dejong

Credit: Peter Dejong

WHO Director-General Tedros Adhanom Ghebreyesus speaks during the opening of the World Health Organisation Academy in Lyon, central France, Monday, Sept. 27, 2021. (Denis Balibouse/Pool Photo via AP)
Caption
WHO Director-General Tedros Adhanom Ghebreyesus speaks during the opening of the World Health Organisation Academy in Lyon, central France, Monday, Sept. 27, 2021. (Denis Balibouse/Pool Photo via AP)

Credit: Denis Balibouse

Credit: Denis Balibouse

FILE - In this Jan. 14, 2021, file photo, a worker in protective coverings directs members of the World Health Organization (WHO) team on their arrival at the airport in Wuhan in central China's Hubei province. China's Foreign Ministry on Thursday, Oct. 14, warned against what it called possible “political manipulation” of a renewed probe by the World Health Organization into the origins of the coronavirus, while saying it would support the international body's efforts.(AP Photo/Ng Han Guan, File)
Caption
FILE - In this Jan. 14, 2021, file photo, a worker in protective coverings directs members of the World Health Organization (WHO) team on their arrival at the airport in Wuhan in central China's Hubei province. China's Foreign Ministry on Thursday, Oct. 14, warned against what it called possible “political manipulation” of a renewed probe by the World Health Organization into the origins of the coronavirus, while saying it would support the international body's efforts.(AP Photo/Ng Han Guan, File)

Credit: Ng Han Guan

Credit: Ng Han Guan

A medical worker stands at an enter of a hospital treating COVID-19 patients in Donetsk, controlled by Russia-backed separatists, Ukraine, Thursday, Oct. 14, 2021. The Russia-backed separatist authorities in eastern Ukraine are reporting the largest spike in new coronavirus infections since the start of the pandemic, saying the health care system has been overwhelmed. The health authorities in the Donetsk region of 2.2 million reported over 1000 new confirmed infections and about hundred coronavirus deaths in the past 24 hours. (AP Photo/Alexei Alexandrov)
Caption
A medical worker stands at an enter of a hospital treating COVID-19 patients in Donetsk, controlled by Russia-backed separatists, Ukraine, Thursday, Oct. 14, 2021. The Russia-backed separatist authorities in eastern Ukraine are reporting the largest spike in new coronavirus infections since the start of the pandemic, saying the health care system has been overwhelmed. The health authorities in the Donetsk region of 2.2 million reported over 1000 new confirmed infections and about hundred coronavirus deaths in the past 24 hours. (AP Photo/Alexei Alexandrov)

Credit: Alexei Alexandrov

Credit: Alexei Alexandrov

Women enjoy a meal outside the Eastwood mall in Quezon city, Philippines as government eases restrictions after a decline in Coronavirus cases in the country on Thursday, Oct. 14, 2021. Several businesses were allowed to reopen in the next days as the country tries to revive the economy which have suffered due to the lockdowns to prevent the spread of COVID-19. (AP Photo/Aaron Favila)
Caption
Women enjoy a meal outside the Eastwood mall in Quezon city, Philippines as government eases restrictions after a decline in Coronavirus cases in the country on Thursday, Oct. 14, 2021. Several businesses were allowed to reopen in the next days as the country tries to revive the economy which have suffered due to the lockdowns to prevent the spread of COVID-19. (AP Photo/Aaron Favila)

Credit: Aaron Favila

Credit: Aaron Favila

People walk on beach during a sunset at Kuta beach, Bali, Indonesia on Thursday, Oct. 14, 2021. The Indonesian resort island of Bali welcomed international travelers to its shops and white-sand beaches for the first time in more than a year Thursday - if they're vaccinated, test negative, hail from certain countries, quarantine and heed restrictions in public. (AP Photo/Firdia Lisnawati)
Caption
People walk on beach during a sunset at Kuta beach, Bali, Indonesia on Thursday, Oct. 14, 2021. The Indonesian resort island of Bali welcomed international travelers to its shops and white-sand beaches for the first time in more than a year Thursday - if they're vaccinated, test negative, hail from certain countries, quarantine and heed restrictions in public. (AP Photo/Firdia Lisnawati)

Credit: Firdia Lisnawati

Credit: Firdia Lisnawati

A woman wearing a face mask to help curb the spread of the coronavirus walks by a billboard depicting medical workers flight against the COVID-19 bearing the words "Wear Face Mask" on display along a hutong alley in Beijing, Thursday, Oct. 14, 2021. (AP Photo/Andy Wong)
Caption
A woman wearing a face mask to help curb the spread of the coronavirus walks by a billboard depicting medical workers flight against the COVID-19 bearing the words "Wear Face Mask" on display along a hutong alley in Beijing, Thursday, Oct. 14, 2021. (AP Photo/Andy Wong)

Credit: Andy Wong

Credit: Andy Wong

Visitors wearing face masks walk under colorful umbrellas on display along a hutong alley near Qianmen Avenue, a popular tourist spot in Beijing, Thursday, Oct. 14, 2021. (AP Photo/Andy Wong)
Caption
Visitors wearing face masks walk under colorful umbrellas on display along a hutong alley near Qianmen Avenue, a popular tourist spot in Beijing, Thursday, Oct. 14, 2021. (AP Photo/Andy Wong)

Credit: Andy Wong

Credit: Andy Wong

A woman takes a picture of her dog outside the Eastwood mall in Quezon city, Philippines as government eases restrictions after a decline in Coronavirus cases in the country on Thursday, Oct. 14, 2021. Several businesses were allowed to reopen in the next days as the country tries to revive the economy which have suffered due to lockdowns to prevent the spread of COVID-19. (AP Photo/Aaron Favila)
Caption
A woman takes a picture of her dog outside the Eastwood mall in Quezon city, Philippines as government eases restrictions after a decline in Coronavirus cases in the country on Thursday, Oct. 14, 2021. Several businesses were allowed to reopen in the next days as the country tries to revive the economy which have suffered due to lockdowns to prevent the spread of COVID-19. (AP Photo/Aaron Favila)

Credit: Aaron Favila

Credit: Aaron Favila

FILE - This Wednesday, Dec. 23, 2020 file photo shows a vial of the Moderna COVID-19 vaccine in the first round of staff vaccinations at a hospital in Denver. U.S. health advisers are debating if millions of Americans who received Moderna vaccinations should get a booster shot -- this time, using half the original dose. Already millions who got their initial Pfizer shots at least six months ago are getting a booster of that brand. On Thursday, Oct. 14, 2021, advisers to the Food and Drug Administration evaluated the evidence that Moderna boosters should be offered, too -- and on Friday, they’ll tackle the same question for those who got Johnson & Johnson’s vaccine. (AP Photo/David Zalubowski, File)
Caption
FILE - This Wednesday, Dec. 23, 2020 file photo shows a vial of the Moderna COVID-19 vaccine in the first round of staff vaccinations at a hospital in Denver. U.S. health advisers are debating if millions of Americans who received Moderna vaccinations should get a booster shot -- this time, using half the original dose. Already millions who got their initial Pfizer shots at least six months ago are getting a booster of that brand. On Thursday, Oct. 14, 2021, advisers to the Food and Drug Administration evaluated the evidence that Moderna boosters should be offered, too -- and on Friday, they’ll tackle the same question for those who got Johnson & Johnson’s vaccine. (AP Photo/David Zalubowski, File)

Credit: David Zalubowski

Credit: David Zalubowski

FILE - In this May 17, 2021, file photo, a health worker prepares to administer the Sputnik V coronavirus vaccine to a man in Hyderabad, India. India was promised 125 million two-dose sets of Sputnik but had administered fewer than 1 million by Oct. 6. (AP Photo/Mahesh Kumar A., File)
Caption
FILE - In this May 17, 2021, file photo, a health worker prepares to administer the Sputnik V coronavirus vaccine to a man in Hyderabad, India. India was promised 125 million two-dose sets of Sputnik but had administered fewer than 1 million by Oct. 6. (AP Photo/Mahesh Kumar A., File)

Credit: Mahesh Kumar A

Credit: Mahesh Kumar A

FILE - In this Feb. 4, 2021, file photo released by Imam Khomeini Airport City, Russian-made Sputnik V COVID-19 vaccines are unloaded at the Tehran's Imam Khomeini International Airport. Millions from Latin America to the Middle East are waiting for promised doses of the Russian-made Sputnik V coronavirus vaccine due to manufacturing problems and other issues. Virus-battered Iran has received only about 1.3 million doses from Russia out of 60 million doses it had been promised. (Saeed Kaari/IKAC via AP, File)
Caption
FILE - In this Feb. 4, 2021, file photo released by Imam Khomeini Airport City, Russian-made Sputnik V COVID-19 vaccines are unloaded at the Tehran's Imam Khomeini International Airport. Millions from Latin America to the Middle East are waiting for promised doses of the Russian-made Sputnik V coronavirus vaccine due to manufacturing problems and other issues. Virus-battered Iran has received only about 1.3 million doses from Russia out of 60 million doses it had been promised. (Saeed Kaari/IKAC via AP, File)

Credit: Saeed Kaari

Credit: Saeed Kaari

FILE - In this Wednesday, April 29, 2020 file photo, a resident from the Alexandra township gets tested for COVID-19 in Johannesburg, South Africa. According to a new study by the World Health Organization, only one in seven COVID-19 infections in Africa are being detected, meaning the continent's estimated infection level may be 59 million people, according to WHO's Africa regional director Matshidiso Moeti who addressed journalists Thursday Oct. 14, 2021. (AP Photo/Jerome Delay, File)
Caption
FILE - In this Wednesday, April 29, 2020 file photo, a resident from the Alexandra township gets tested for COVID-19 in Johannesburg, South Africa. According to a new study by the World Health Organization, only one in seven COVID-19 infections in Africa are being detected, meaning the continent's estimated infection level may be 59 million people, according to WHO's Africa regional director Matshidiso Moeti who addressed journalists Thursday Oct. 14, 2021. (AP Photo/Jerome Delay, File)

Credit: Jerome Delay

Credit: Jerome Delay