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Published: 10:10, December 02, 2021 | Updated: 18:34, December 02, 2021
GSK says tests show antibody drug works against Omicron
By Agencies
Published:10:10, December 02, 2021 Updated:18:34, December 02, 2021 By Agencies

A picture taken on Feb 6, 2020 shows the logo of the GSK Vaccines pharmaceutical company at its headquarters in Wavre, Belgium. (KENZO TRIBOUILLARD / AFP)

UNITED NATIONS / LONDON / GENEVA / NEW YORK / WASHINGTON / PARIS / BRUSSELS / COPENHAGEN / LOS ANGELES / DUBLIN / STOCKHOLM / BERLIN / LISBON / AMSTERDAM - GlaxoSmithKline on Thursday said that a lab analysis of the antibody-based COVID-19 therapy it is developing with US partner Vir has shown the drug is effective against the new Omicron variant.

In a statement, the British drugmaker said that lab tests and a study on hamsters have demonstrated the sotrovimab antibody cocktail to work against viruses that were bio-engineered to carry a number of hallmark mutations of the Omicron variant.

The tests are ongoing to confirm the results against all of the Omicron mutations with an update expected by year-end, it added.

Separately, Britain's drug regulator on Thursday approved sotrovimab, also known under the brand name Xevudy, for people with mild to moderate COVID-19 who are at high risk of developing severe disease.

The Medicines and Healthcare products Regulatory Agency (MHRA) recommended use of Xevudy as soon as possible and within five days of the onset of symptoms.

Danish Prime Minister Mette Frederiksen arrives for an EU summit in Brussels, Friday, Oct 22, 2021. (OLIVIER HOSLET / POOL PHOTO VIA AP)

Denmark

Vaccination and revaccination is the "super weapon" in the fight against COVID-19 and for keeping Denmark open, Danish Prime Minister Mette Frederiksen told a news conference on Wednesday.

Her comments came as the country's Statens Serum Institut (SSI) had registered 5,120 confirmed cases of COVID-19 infection in the last 24 hours, the highest daily infection rate since the start of the pandemic.

"This (infection rate) is also due to the new Omicron variant. We know from previous variants that time is a decisive factor (in controlling the pandemic)," the PM said.

Frederiksen emphasized the importance of a third booster vaccine for the elderly and medical personnel.

"To grandparents, vulnerable people, frontline personnel, and all of you who were vaccinated last winter and in the spring: A very, very strong call to take the third vaccine," the PM said.

In Denmark, 14.5 percent of the population, or 849,221 people, have so far received a booster vaccine, according to the SSI.

European Commission President Ursula von der Leyen delivers a statement on  COVID-19 pandemic at the European Commission headquarters in Brussels, Belgium on Nov 26, 2021. (JOHANNA GERON / POOL PHOTO VIA AP)

European Union

The European Union (EU) should start a discussion on whether mandatory vaccinations are needed in the fight against the ongoing surge in COVID-19 cases, especially since a third of the EU population had not yet taken the jab, European Commission President Ursula von der Leyen said here on Wednesday.

Acknowledging that such a decision was "pure member state competence," she noted that around 150 million people in the EU had not taken the jab.

"I think it is understandable and appropriate to lead this discussion now - how we can encourage and potentially think about mandatory vaccination within the EU," she said during a news conference.

"We have the vaccines, the life-saving vaccines, but they are not being used adequately everywhere," she said.

ALSO READ: EU urges daily travel reviews, booster shots over Omicron

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)

France

France on Thursday reported its first case of the new Omicron coronavirus variant near Paris as the government's top scientific adviser said it could become dominant in the country by the end of January.

The health body for the Ile de France region of greater Paris said in a statement an Omicron case had been found in a person who returned from Nigeria. This followed a case found in the French Indian Ocean island of La Reunion last month.

Jean-Francois Delfraissy told BFM television the "true enemy" for now was still Delta, spreading in a fifth wave.

"We should see a progressive rise of the Omicron variant, which will take over from Delta," possibly by the end of January, he said.

He said it should be possible to have a good Christmas if steps are taken to curb the Delta strain.

"Christmas is not at risk if the population and decision-makers are all very cautious," he said, reiterating that social distancing and a third, booster shot of vaccines were key weapons.

France recorded nearly 50,000 new conformed COVID-19 cases over 24 hours, the Health Ministry said on Wednesday.

Separately, France will require all travelers arriving in the country from outside the European Union (EU) to present a negative COVID-19 test regardless of their vaccination status , government spokesperson Gabriel Attal said here on Wednesday.

The move is aimed at tackling the new surge in infections and at keeping the new Omicron virus variant out.

As of Dec 1, already vaccinated international arrivals must present a negative test carried out within the previous 48 hours. Non-vaccinated travelers must provide a negative test taken less than 24 hours before boarding, he said.

The recently announced ban on flights from seven African countries will be adjusted on Dec 4, Attal said, to allow French and EU citizens, permanent residents in France as well as diplomats and seafarers to enter France from the seven African countries currently covered by the flight ban.

Intensive care nurses treat patients severely ill with COVID-19 in the Corona intensive care unit at the University Hospital in Halle/Saale on Nov 22, 2021. (HENDRIK SCHMIDT / DPA VIA AP)

Germany

Germany is expected to impose restrictions on the unvaccinated on Thursday as it seeks to break a dramatic surge in daily coronavirus infections exacerbated by the discovery of the Omicron strain.

Outgoing Chancellor Angela Merkel and her successor, Olaf Scholz will discuss with leaders of Germany's 16 states restricting the unvaccinated from access to all but the most essential businesses, such as grocery stores, pharmacies and bakeries.

Eager to avoid lockdowns that could derail a fragile recovery of Europe's biggest economy, they are expected to keep businesses open to the almost 69 percent of the population that is fully vaccinated as well as those who have recovered from the coronavirus.

Virologists have blamed the fourth wave, which risks overwhelming intensive care units and on Thursday resulted in more than 73,000 new infections and 388 deaths, on resistance to vaccination by a large section of society. They have also criticized politicians for acting too late.

Germany's vaccination rate at just under 70 percent is around the EU average but lower than countries such as Portugal and Ireland.

Making vaccination compulsory and restricting the number of people at large events such as soccer matches are among the measures to be discussed.

There have been signs the curve is starting to flatten. The 7-day incidence among 100,000 residents fell for the third consecutive day to 439.2.

Ireland

Ireland has detected its first case of the Omicron coronavirus variant, said the country's Department of Health on Wednesday.

The case is associated with travel from one of the southern African countries that have been declared by the Irish government as high-risk countries for the spread of the new variant, said the department in a statement, without giving further details.

The Irish national radio and television broadcaster RTE reported earlier in the day that the Dublin-based National Virus Reference Laboratory had carried out tests on a number of samples over the weekend and one of the eight samples that underwent genome sequencing was confirmed having the Omicron variant.

The report said scientists are not aware of any additional cases associated with the confirmed case, and there is no evidence of community transmission of the variant so far.

Italy

Italy’s medicines agency Aifa approved the use of the COVID-19 vaccine from Pfizer Inc and BioNTech SE for children aged 5-11.

The approval follows that of the European Union’s drugs regulator last month. Two shots will be administered at a three-week interval, and the dosage for kids will be a third of that given to adults and adolescents. 

The vaccine has shown a “high level of effectiveness and at the moment there are no warning signals in terms of safety,” Aifa’s scientific panel said in a statement on Wednedsay evening. 

People wait at an Italian Red Cross anti COVID-19 vaccination hub, in Rome on Nov 29, 2021. (GREGORIO BORGIA / AP)

The agency said that the vaccine will allow children to attend school and conduct a normal life, which is particularly important at that age.

Italy is facing a resurgence of cases, which prompted the government to issue new rules that will all but shut out unvaccinated people from leisure activities. 

Proof of vaccination, recovery or a recent negative test is already required to work, travel and access most indoor venues. 

Many cities, including Rome and Milan, have also introduced an outdoor mask mandate for crowded areas and city centers.

This file photo taken on June 4, 2021 shows a vial of the Moderna COVID-19 vaccine at a pharmacy in Paris, France. (STEPHANE DE SAKUTIN / AFP)

Moderna Inc

Moderna Inc could have a COVID-19 booster shot targeting the Omicron variant tested and ready to file for US authorization as soon as March, the company's president said on Wednesday.

Moderna President Stephen Hoge said he believes booster shots carrying genes specifically targeting mutations in the newly-discovered Omicron variant would be the quickest way to address any anticipated reductions in vaccine efficacy it may cause.

"We've already started that program," he told Reuters.

The company is also working on a multi-valent vaccine that would include up to four different coronavirus variants including Omicron.

That could take several more months, he said.

Given prior guidance from the US Food and Drug Administration, which has required mid-stage clinical testing, Hoge said the process could take three or four months.

"The Omicron-specific boosters, just realistically, are not before March and maybe more in the second quarter," Hoge said, unless the FDA changes its guidance for what data would be needed for authorization.

Moderna would be able to manufacture the vaccine as it was conducting the testing, Hoge said, to have it ready to roll out as soon as possible.

Netherlands

Dutch health authorities said that more than 20 passengers who have been in quarantine since testing positive for COVID-19 after flying from South Africa on Nov. 26 will be allowed to leave on Thursday.

A spokesman for the health authority for Kennemerland, in which Schiphol airport is situated, said authorities will not disclose whether any of the 14 passengers found to be infected with the Omicron variant of the virus are being released, citing privacy reasons.

They will also not disclose or discuss the seriousness of those patients' symptoms, the spokesman added, also citing privacy reasons.

The GGD tested more than 600 passengers who arrived on two flights that had departed from Johannesburg and Cape Town on Friday, before the Dutch government changed its rules on air traffic from southern Africa because of concerns over the Omicron variant.

Of 62 passengers who tested positive for COVID-19, 44 were held in isolation in a hotel near Schiphol airport, while some Dutch citizens have been in quarantine at home.

Results of follow-up tests on Monday mean that more than half of those who had been held at the hotel are now free to continue their travels, a GGD statement said.

"Persons that tested positive will remain in isolation. Their situation varies ... some have symptoms, others don't or barely," GGD Kennemerland director Bert van Velden said in a statement.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 Inc

Pfizer Inc said on Wednesday it had started the real-time submission of its application seeking Health Canada's approval of its oral COVID-19 antiviral drug candidate.

The pill, PF-07321332, is designed to block a key enzyme needed for the coronavirus to multiply.

The move comes after the Canadian government announced on Tuesday that it was in advanced talks with Pfizer and Merck & Co Inc regarding a purchase agreement for their COVID-19 antiviral drugs, as the country attempts to control the spread of the Omicron coronavirus variant.

Portugal

The wave of coronavirus infections in Portugal is expected to worsen and new daily cases could double to around 9,000 during the Christmas period, the health authority DGS chief Graca Freitas told broadcaster RTP.

The country of just over 10 million reported a total of 4,670 new infections on Wednesday, the highest daily jump since the beginning of February, when it faced its toughest battle against the virus.

However, Freitas said vaccination levels - among the highest in the world at around 87 percent of the population - should mean hospitalizations and deaths remain far below levels seen during previous waves of the pandemic, particularly in February.

"It is very different to have new cases than to have lethal cases," she said late on Wednesday, even though increased movement over the Christmas period could mean a surge in infection rates.

Slovenia

Slovakia will send hospitality vouchers worth 500 euros ($567) to seniors who are fully inoculated against COVID-19 in a bid to increase one of the European Union’s lowest vaccination rates and prevent future lockdowns.

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

South Africa

South Africa’s daily number of confirmed COVID-19 cases almost doubled from Tuesday as the omicron variant takes hold. 

The country recorded 8,561 infections in the last 24 hours and a positivity rate of 16.5 percent on tests, according to the National Institute for Communicable Diseases.

The omicron variant was found in 74 percent of the 249 COVID-19 samples that were gene-sequenced in November, the institute said. 

The Delta variant accounted for 22 percent, compared with 79 percent in October. Omicron was found in samples in five out of the country’s nine provinces.

Sweden

The Swedish Public Health Agency said on Thursday it could impose new restrictions to fight the coronavirus pandemic and a rising tide of infections in the coming days.

Sweden, which introduced vaccine passes for indoor events with more than 100 people at the beginning of this month, had flagged potential additional measures might be needed to curb the spread of the virus.

“We may have to take measures already next week,” Karin Tegmark Wisell, Director General at Sweden’s Public Health Agency, told a news conference.

People wear face masks as they walk, in Regent Street, in London on Nov 28, 2021. (AP Photo/Alberto Pezzali)

UK

Prime Minister Boris Johnson issued a "call to get jabs in arms" on Wednesday as Britain stepped up its COVID-19 booster program to fend off the Omicron variant after another 10 cases of the new strain were identified.

Britain has now recorded 32 cases of the Omicron variant, which appears to be more transmissible, while tests continue to see whether it causes more severe disease or if vaccines are less effective against it.

"It is very likely that we will find more cases over the coming days as we are seeing in other countries globally," said Jenny Harries, chief executive of the UK Health Security Agency.

Johnson announced a new target this week to offer all adults a booster vaccine shot by the end of January, which means speeding up the country's program by an extra million doses a week.

"This isn't a call to arms, but a call to get jabs in arms. And quickly," he said on Twitter.

Meanwhile, Britain said it had agreed deals to buy 114 million more Pfizer/BioNTech and Moderna COVID-19 vaccine shots, saying it had sped up signing the new contracts in light of the emergence of the new Omicron variant.

The deal involves an additional 60 million Moderna shots and 54 million Pfizer doses for next year and 2023, and will also include access to any modified vaccinations if they are needed to combat the Omicron strain or any other variant, the British health ministry said.

United Nations Secretary-General Antonio Guterres speaks to reporters at the UN headquarters in New York, on Oct 11, 2021. (PHOTO / XINHUA)

United Nations

United Nations Secretary-General Antonio Guterres said on Wednesday that travel restrictions imposed over COVID-19 that isolate any one country or region as "not only deeply unfair and punitive - they are ineffective."

Speaking to reporters in New York, Guterres said the only way to reduce the risk of transmission while allowing for travel and economic engagement was to repeatedly test travelers, "together with other appropriate and truly effective measures."

"We have the instruments to have safe travel. Let's use those instruments to avoid this kind of, allow me to say, travel apartheid, which I think is unacceptable," Guterres said.

Omicron was first identified in southern Africa and many countries have announced travel curbs and other restrictions on the region. Africa has some of the lowest COVID-19 vaccination rates worldwide due to a lack of access to doses.

Guterres has long warned about the dangers of vaccine inequality around the world and that low immunization rates are "a breeding ground for variants."

"These travel bans are not justified," said African Union Commission Chair Moussa Faki Mahamat at the joint news conference with Guterres after the annual meeting between the United Nations and the African Union.

San Francisco Mayor London Breed talks about the first confirmed case of the omicron variant during a COVID-19 briefing outside City Hall in San Francisco on Dec 1, 2021. (ERIC RISBERG / AP)

United States

The United States has identified the country's first confirmed case of the Omicron COVID-19 variant in the state of California, health authorities said Wednesday.

The California and San Francisco Departments of Public Health have confirmed that a recent case of COVID-19 among an individual in California was caused by the Omicron variant. The individual was a traveler who returned from South Africa on Nov 22, the US Centers for Disease Control and Prevention (CDC) said in a news release.

Officials said that genomic sequencing was conducted at the University of California, San Francisco and the sequence was confirmed at CDC as being consistent with the Omicron variant.

The individual, who was fully vaccinated and had mild symptoms that are improving, is self-quarantining and has since tested positive. All close contacts have been contacted and have tested negative, according to the CDC.

A traveler adjusts his face mask as he walks through the arrivals area at the Los Angeles International Airport in Los Angeles on Nov 30, 2021. (JAE C. HONG / AP)

In another development, US officials ordered airlines to disclose passenger names and other information about those who have recently been in eight southern African countries and will give it to local and state public health agencies, according to documents seen by Reuters.

The CDC told airlines in a letter late Tuesday that they must turn over names and contact information for any travelers who within 14 days have been to Botswana, Eswatini, Lesotho, Malawi, Mozambique, Namibia, South Africa and Zimbabwe, citing "the emergence of the Omicron variant of the virus that causes COVID-19".

"(The CDC) will provide the contact information of these passengers to jurisdictional state and local public health partners for public health follow-up. This follow-up may include recommendations for potential postarrival viral testing and quarantine and isolation," the agency told airlines.

The new directive, which took effect late Tuesday and was seen by Reuters, mandates airlines to turn over the information within 24 hours of passengers arriving in the United States who have been in one of the eight African countries.

The collected information includes full name, full address while in the United States, primary contact phone number, secondary or emergency contact phone number, and email address.

Technical lead head COVID-19 Maria Van Kerkhove attends a press conference organized by Geneva Association of United Nations Correspondents (ACANU) amid the COVID-19 outbreak on July 3, 2020 at the WHO headquarters in Geneva. (FABRICE COFFRINI / POOL / AFP)

WHO

The World Health Organization expects to have more information on the transmissibility of the new Omicron variant of the coronavirus within days, its technical lead on COVID-19, Maria van Kerkhove, said in a briefing on Wednesday.

That was faster than the "weeks" the WHO had predicted last week that it would take to assess the data available on the variant after designating it a "variant of concern", its highest rating.

Whether the variant is more transmissible or evades vaccines are some of the major questions that still need answering.

Vaccine developers have said it will take about two weeks to assess whether their shots are effective against it.

Van Kerkhove said one possible scenario was that the new variant, which was first reported in southern Africa, may be more transmissible than the dominant Delta variant. She said it was not yet known if Omicron makes people more ill.

WHO chief scientist Soumya Swaminathan said the agency believes the existing COVID-19 vaccines will work against the variant.

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