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Merck’s COVID-19 pill gets US FDA panel’s key backing

This undated file image provided by Merck and Co shows their new antiviral medication molnupiravir. (MERCK AND CO VIA AP)

MADRID / LONDON / LJUBLJANA / GENEVA / LISBON / VIENNA / JOHANNESBURG / QUITO / PARIS – Merck & Co’s COVID-19 pill gained a key recommendation from advisers to US regulators, increasing the likelihood that the treatment for high-risk patients will be cleared for use in the US.

The Food and Drug Administration’s advisory committee voted 13-10 to back Merck’s anti-viral drug molnupiravir, saying the benefits outweigh the risks.

The pill is intended to treat mild-to-moderate COVID-19 in adults at risk of developing severe illness. Merck developed the treatment with partner Ridgeback Biotherapeutics LP.

The decision comes amid rising concerns about a new coronavirus variant that is described by scientists as different from previous incarnations and potentially of serious concern. Pfizer Inc and partner BioNTech SE, Moderna Inc and Johnson & Johnson are working to adapt their COVID-19 vaccines to address the omicron variant.

The FDA is not obligated to follow the recommendations of the panel, called the Antimicrobial Drugs Advisory Committee, though it typically does. A decision from the agency on whether to clear the pill could come soon after the meeting concludes on Tuesday.

The pill could be a game-changer in the fight against the pandemic by turning COVID-19 into an illness that is easily treated outside of a hospital setting. That may relieve the strain on health systems stretched thin by staffing shortages and rising infection levels.

Unlike other COVID-19 antivirals that are administered via intravenous infusion usually in hospitals or clinics, a five-day course of molnupiravir can be taken by patients at home. 

Regulators have already allowed Merck’s pill to be used in emergency treatment of adults in the European Union. It hasn’t been formally authorized for sale.

People crowd a Christmas market in Vienna, Austria on Nov 21, 2021. The Austrian government announced a nationwide lockdown that will start Monday and comes as average daily deaths have tripled in recent weeks and hospitals in heavily hit states have warned that intensive care units are reaching capacity. (VADIM GHIRDA / AP)

Austria

An Austrian parliamentary committee on Tuesday, as widely expected, approved a decree extending the country’s COVID-19 lockdown by 10 days, bringing its total duration to 20 days, which the government has said is the longest it will last.

Faced with surging daily coronavirus infections, the conservative-led government introduced the lockdown on Monday of last week, the first country in Western Europe to reimpose a lockdown this autumn.

Roughly 67 percent of Austria’s population is fully vaccinated against the coronavirus, one of the lowest rates in Western Europe. Many Austrians are sceptical about vaccines, a view encouraged by the far-right Freedom Party, the third biggest in parliament.

New daily infections have fallen below 9,000 from a peak above 15,000 the week before the lockdown began. Tuesday’s figure of 8,186 is still only slightly below the previous peak of 9,586 set in November of last year, when vaccines were not available and a national lockdown was imposed.

Austria’s total confirmed death toll from COVID-19 is 12,492.

The main committee of Austria’s lower house of parliament, which is responsible for vetting certain major government decisions, approved the lockdown extension through Dec. 11, parliament said in a statement.

A medical staff member prepares a syringe with a dose of the Pfizer-BioNTech (Comirnaty) COVID-19 vaccine, in the Lyon Gerland vaccination center, on Nov 27, 2021. (JEFF PACHOUD / AFP)

BioNTech

The Omicron variant of the coronavirus could lead to more infections among vaccinated people, but they will most likely remain protected from a severe course of illness, Dow Jones reported, based on an interview with the inventor of one of the first COVID-19 vaccines.

While the new variant might evade the antibodies generated in reaction to the vaccine, the virus will likely remain vulnerable to immune cells that destroy it once it enters the body, BioNTech SE co-founder Ugur Sahin said.

Brazil

Brazil detected two cases of the Omicron variant in preliminary testing, the first cases of the new strain confirmed in Latin America. 

The variant was spotted in samples from a traveler who had recently arrived from South Africa and his wife, health watchdog Anvisa said in a note on Tuesday. The tests will be repeated for further confirmation, it said, giving no further information about the patients. 

Earlier on Tuesday, O Globo newspaper reported a woman recently arrived from the Democratic Republic of the Congo tested positive for COVID-19 and was hospitalized in the state of Minas Gerais. 

Countries including Brazil tightened travel restrictions over the past few days amid news of the new variant.

British Prime Minister Boris Johnson shakes a dose of the Pfizer vaccine as it is diluted before being administered as he visits a COVID-19 vaccination center at Little Venice Sports Centre, in London, Oct. 22, 2021. (MATT DUNHAM / AP / POOL)

Britain

British Prime Minister Boris Johnson said Tuesday that everyone over the age of 18 will be offered a booster vaccine by the end of January and another lockdown “extremely unlikely”.

Speaking at a Downing Street news briefing on Tuesday, the prime minister said the rollout of booster program will go in age order, and that there will be more than 1,500 community pharmacy sites in England offering the jabs.

“Temporary vaccine centers will be popping up like Christmas trees”, adding that some 400 military personnel and the “jabs army of volunteers” will also help with the rollout, Johnson said.

A further eight cases of the new Omicron COVID-19 variant have been identified in England, bringing the total number of confirmed cases of the SARS-CoV-2 variant known as B.1.1.529 in Britain to 22, according to the UK Health Security Agency (UKHSA).

ALSO READ: UN agency: Travel bans to stop Omicron spread a ‘mistake’

In this file photo taken on May 15, 2021, people wait for their COVID-19 vaccine inside the International Conference Center during Peel Region’s “Doses After Dark” overnight COVID-19 vaccination clinic in Mississauga, Ontario, Canada. (COLE BURSTON / AFP)

Canada

Prime Minister Justin Trudeau’s government tightened travel restrictions meant to contain the spread of the omicron variant of COVID-19 as Canada identifies more suspected cases already in the country.

The government will now require all air travelers into Canada – from countries other than the US – to test at the airport, whether they are vaccinated or not, Health Minister Jean-Yves Duclos said Tuesday at a press conference. 

Canada is also considering new testing rules for travelers from the US by both land and air if needed.

“These rules have always changed over the last 20 months and will continue to change as the situation evolves,” Duclos said.

Foreign nationals who have recently been in Nigeria, Egypt and Malawi were added to the list of travelers banned from entering Canada. The move comes after travel from an initial seven southern African countries was restricted last week.

Canada confirmed its first two cases of the variant over the weekend, both in Ottawa and connected to travelers from Nigeria. Another two cases have been reported in Ontario, as well as one in Quebec and another in Alberta.

Separately, the government said on Tuesday it was in advanced talks with Pfizer Inc and Merck & Co Inc regarding a purchase agreement for COVID-19 antiviral drugs.

Residents wait to be vaccinated against COVID-19 in Guayaquil, Ecuador, July 22, 2021. (DOLORES OCHOA / AP)

Ecuador

Ecuador’s foreign ministry said on Tuesday that it would keep the country’s border with Peru closed in an effort to stop the spread of the coronavirus’ Omicron variant.

Peru announced that as of Dec 1, it would open its land border for residents and non-residents coming from Ecuador and Chile, complying with the protocols of the country’s health authority.

“The Ecuadorian foreign ministry reiterates the decision to keep the land border with Peru closed, as a prevention and control response to the spread of the COVID-19 pandemic and its new variants,” the ministry said in a statement.

“The country’s authorities maintain frequent communication with their Peruvian counterparts, so that the reopening of the borders is carried out gradually and in an orderly manner,” it added.

Ecuadorian President Guillermo Lasso announced on Monday night that he plans to gradually open the border with Colombia starting Wednesday, allowing cargo and commercial goods to cross.

Ecuador has accelerated its plans to dole out booster vaccine shots given the omicron variant’s advance through several countries.

The booster shots, scheduled to start on January 1, 2022, will now begin being distributed Dec 1, Health Minister Ximena Garzon told reporters.

By the end of December Ecuador hopes to vaccinate 85% of its population, including minors from the age of five.

Finland

Finland is set to mandate social and health-care staff to take vaccinations against the coronavirus and plans to widen the use of COVID-19 passports beyond bars and restaurants, Krista Kiuru, the minister overseeing the pandemic response efforts, told reporters in Helsinki on Tuesday. 

The government also told regional authorities to boost test-and-trace efforts and to recommend remote work in areas where the virus is spreading, she said.

Finland has already ordered bars to stop alcohol sales at 5 pm starting Nov 28 unless they require customers to present a COVID-19 passport, and the Helsinki region last week recommended a return to remote work as well as widespread mask use.

Protesters take part in a demonstration in front of the Prefecture of Martinique in Fort-de-France, during a meeting of French Overseas Minister with trade union representatives, on the French Caribbean island of Martinique, on Nov 30, 2021, after days of violent protests sparked by COVID-19 restrictions and social grievances. (ALAIN JOCARD / AFP)

France

Police reinforcements arrived in the French Caribbean territory of Martinique on Tuesday to restore order after unrest that erupted over COVID-19 measures, in particular the mandatory vaccination of healthcare workers, a government minister said.

Martinique, and before it the nearby island of Guadeloupe, has seen several days of protests against COVID-19 measures that spilled over into violence.

Sebastien Lecornu, the minister for France’s overseas territories, said 70 gendarmes had arrived earlier in the day, in addition to two squadrons that were deployed from metropolitan France unannounced, to help clear road blocks.

“Social dialogue is not possible without a sound basis and that sound basis is the re-establishment of freedoms … and our capacity to re-establish order,” Lecornu told a press conference in Martinique after meeting its leaders and trade unions.

Germany

Germany took a step closer toward making COVID-19 vaccinations compulsory as the incoming chancellor threw his support behind the move, part of a tougher line by European leaders as the pandemic spirals out of control.

Olaf Scholz called for a parliamentary vote on the step before the end of the year, saying on Tuesday that he would allow lawmakers to make the decision.

Ireland

Ireland will require all people arriving from abroad to provide a negative COVID-19 test from Friday, including those arriving from Great Britain, according to a person familiar with the matter.

Travelers arriving into Ireland must provide a negative PCR test taken no more than 72 hours before travel or a negative antigen test taken no more than 48 hours ahead, said the person, who asked not to be named as the information is not yet public. 

Unvaccinated people must provide a PCR test, they said. A formal announcement may come later today.

The move to require all arrivals to provide a test comes even though Ireland and the UK as a whole are part of the common travel area which allows passport free travel between those jurisdictions. 

The UK recently exempted Ireland from its own plan to require travelers to self-isolate and test negative for the coronavirus on arrival.

An elderly couple wearing protective face masks against COVID-19 walks past the Pfizer Inc headquarters on Dec 9, 2020 in New York City. (ANGELA WEISS / AFP)

Pfizer

Pfizer Inc’s Chief Executive Officer Albert Bourla said on Tuesday the company has submitted a request to the US Food and Drug Administration seeking the authorization for its COVID-19 booster doses for use in 16- and 17-year olds.

If given the go-ahead, Pfizer’s booster vaccine will be the first to be cleared for use in the younger age group.

The Wall Street Journal reported on Monday that the FDA could approve Pfizer’s booster doses for 16- and 17-year olds as soon as next week.

Portugal

A large hospital near Lisbon, the Portuguese capital, said on Tuesday it has temporarily shut two of its pediatric departments after a health worker, who is also the doctor for a COVID-hit soccer team, tested positive for the Omicron variant of the coronavirus.

The Garcia de Orta hospital in Almada, a city on the other side of the River Tagus from Lisbon, said the pediatric emergency and outpatient departments would close from 10 pm on Tuesday for a period of 14 days.

In a statement, the hospital said all those who were in contact with the infected health worker, a total of 28 people, were now in isolation and being monitored.

Portuguese health authorities detected on Monday 13 cases of the Omicron variant, all involving players and staff of top division soccer club Belenenses SAD, one of whose players recently returned from South Africa.

A Belenenses SAD spokesman told Reuters that the health worker infected with the Omicron variant at the Garcia de Orta hospital was also the doctor of the Belenenses SAD squad.

ALSO READ: WHO: Omicron poses ‘very high’ global risk, nations must prepare

Slovenia

In Slovenia, a committee of experts confirmed that the death in September of a 20-year-old woman was linked to Janssen’s COVID-19 vaccine, an official said here on Tuesday.

Zoran Simonovic of the National Institute of Public Health told a news conference that the committee of five experts “unanimously assessed that in this case there is a definite relation between Johnson & Johnson’s Janssen vaccine and the tragic complication.”

The woman died 13 days after receiving the vaccine because she developed “thrombosis with thrombocytopenia,” according to a statement issued by the government.

As a consequence, on Sept. 29 the Ministry of Health decided to stop using the Janssen vaccine, and on Oct 12 it recommended the priority use of mRNA (messenger ribonucleic acid) vaccines against COVID-19, such as those produced by Pfizer/BioNTech and Moderna.

A member of staff checks the European COVID-19 passport on a woman’s phone at a restaurant, in Pamplona, northern Spain on Nov 29, 2021. (ALVARO BARRIENTOS / AP)

Spain

Spain’s Health Minister Carolina Darias said on Tuesday that vaccines to protect children aged between 5 and 11 against COVID-19 will arrive in Spain in the second half of December.

In an interview with local radio station Cadena SER, Darias explained that although the European Medicines Agency (EMA) last week gave the go-ahead for the vaccination of this age group, it still has to be approved by Spain’s Public Health Commission.

“The incidence of the virus is currently the highest in children, standing at 230 cases per 100,000,” she said.

Darias also confirmed that a 51-year-old man who returned to Spain from South Africa was the first case of the Omicron variant in Spain.

“He has mild symptoms,” she said, adding that another couple who had landed in Barcelona with suspected Omicron variant were undergoing tests and were currently “fine.”

Switzerland

Switzerland is considering reintroducing a work-from-home mandate as part of policies to tackle the latest wave of the coronavirus.

The government is in talks with regional authorities on a number of options, including forcing the unvaccinated to work from home. Another option is to require workers in indoor settings to wear masks.

Authorities may increase the use of the COVID-19 certificate, which shows if someone has been vaccinated, tested or recovered.

Also up for debate is reducing the number of people allowed at private gatherings without a certificate and cutting the time period under which COVID-19 tests are valid to 24 hours, in the case of rapid antigen tests. Any measure should end on Jan 24.

Director of the Centers for Disease Control and Prevention (CDC) Rochelle Walensky testifies during a Senate Appropriations Subcommittee hearing to examine the FY 2022 budget request for the Centers for Disease Control and Prevention on May 19, 2021 in Washington, DC. (GREG NASH / POOL / AFP)

United States

The Centers for Disease Control and Prevention is considering tightened travel recommendations and rules as health officials try to slow the COVID-19 Omicron variant’s entry to the US.

The agency is looking measures such as narrowing the testing window for travelers into the country and adding quarantine requirements in certain cases, CDC Director Rochelle Walensky said Tuesday on a call with reporters. It’s also expanding surveillance programs at four major airports to test for COVID-19 from specific international arrivals.

“As we have done throughout the pandemic, CDC is evaluating how to make international travel as safe as possible,” she said on the call. 

The country last week imposed travel restrictions that bar arrivals from foreign nationals who have been in any of eight southern African nations in the past 14 days. The administration hasn’t said how long those measures will be in place.

In another development, the Biden administration was blocked on Tuesday from enforcing two mandates requiring millions of American workers to get vaccinated against COVID-19, a key part of its strategy for controlling the spread of the coronavirus.

US District Judge Terry Doughty in Monroe, Louisiana, temporarily blocked the Centers for Medicare & Medicaid Services (CMS) from enforcing its vaccine mandate for healthcare workers until the court can resolve legal challenges.

Doughty’s ruling applied nationwide, except in 10 states where the CMS was already prevented from enforcing the rule due to a prior order from a federal judge in St. Louis.

Doughty said the CMS lacked the authority to issue a vaccine mandate that would require more than 2 million unvaccinated healthcare workers to get a coronavirus shot.

“There is no question that mandating a vaccine to 10.3 million healthcare workers is something that should be done by Congress, not a government agency,” wrote Doughty.

This photograph taken on March 5, 2021 shows the flag of the World Health Organization (WHO) at their headquarters in Geneva amid the COVID-19 outbreak. (FABRICE COFFRINI / AFP)

WHO

Countries should apply “an evidence-informed and risk-based approach” with any travel measures related to the Omicron variant of the coronavirus, including possible screening or quarantine of international passengers, but blanket bans do not prevent its spread, the World Health Organization (WHO) said on Tuesday.

National authorities in countries of departure, transit and arrival may apply a multi-layered approach to mitigate risk so as to delay or reduce importation or exportation of the Omicron variant, the WHO said on Tuesday.

“Measures may include screening of passengers prior to travel and/or upon arrival, and use of SARS-COV-2 testing or quarantine of international travelers after thorough risk assessment,” it said.

All measures should be commensurate with the risk, time-limited and applied with respect to travelers’ rights, it said.

“Blanket travel bans will not prevent the international spread, and they place a heavy burden on lives and livelihoods,” it said.

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