The Latest: Europe Medicines Agency looking at antibody drug

By The Associated Press 15 October 2021, 12:00AM

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.

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MORE ON THE PANDEMIC:

Women trailing men in some coronavirus vaccine campaigns

Bali reopens to foreign travelers as COVID-19 surge subsides

— Experts say comfort is key when choosing a face mask

— Russia, WHO differ on when approval will come for Sputnik V

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

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HERE’S WHAT ELSE IS HAPPENING:

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.

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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.

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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.

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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.

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SARE GIBEL, Gambia — Health officials are confronting vaccine reluctance among African women, especially those of childbearing age.

Many worry pregnancies will be threatened, and in Africa, the success of a woman’s marriage often depends on how many children she bears. Other women fear the vaccine more than COVID-19; as breadwinners, they can’t miss a day working if side effects hit.

Their fears are hardly exceptional, with rumors proliferating across Africa. Fewer than 4% of of Africans are immunized. Although gender data are lacking globally, experts see a growing number of women in Africa’s poorest countries consistently missing vaccines.

Officials who already bemoan the inequity of vaccine distribution between rich and poor nations now fear African women are the world’s least vaccinated population.

Despite rampant concerns about pregnancy and fertility, there is no evidence that vaccines affect a woman’s chances of getting pregnant. The CDC, World Health Organization, and other agencies recommend pregnant women get vaccinated because they’re at higher risk of severe disease and death.

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DENPASAR, Indonesia — The Indonesian resort island of Bali reopened for international travelers to visit 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.

However, foreign visitors may be slow to arrive. No international flights to Bali were scheduled on the first day of the reopening, and a tourism official forecast travel would pick up in November.

Bali’s airport will welcome new foreign arrivals from 19 countries that meet World Health Organization’s criteria such as having their COVID-19 cases under control, Luhut Binsar Pandjaitan, the government minister who leads the COVID-19 response in Java and Bali, said in a statement late Wednesday.

He said all international flight passengers must have proof they’ve been vaccinated two times, test negative for the coronavirus upon arrival in Bali and undergo a 5-day quarantine at designated hotels at their own expense. They’ll also have to follow stringent rules at hotels, in restaurants and on beaches.

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PRAGUE — Czech Prime Minister Andrej Babis has received a third dose of a coronavirus vaccine and used the opportunity to appeal to his country's people to get vaccinated.

The 67-year-old Babis is among more than 30,000 Czechs who have gotten booster shots. The Czech Republic has offered vaccine boosters since Sept 20 to individuals over age 60, health care workers and other vulnerable groups.

Yet more than 340,000 people over the age of 65 haven’t received a single shot, a reason for concern, Babis said.

“I’m calling on everyone to get vaccinated,” the prime minister said. “The vaccination is the only solution to save lives.”

The Czech Republic has reported about 1,500 new coronavirus cases for three straight days, numbers unseen since early May.

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BUDAPEST, Hungary -- Hungary expects to receive this year the technology needed to produce Russia's Sputnik V COVID-19 vaccine at a Hungarian factory that is currently under construction, the country's foreign minster said Thursday.

The vaccine, Russia’s Sputnik V, has been approved in more than 70 countries and was used widely in Hungary’s vaccination drive earlier this year. The Central European country purchased enough doses for 1 million people, and was the first country in the European Union to use the jab.

“We have now agreed to take cooperation on vaccines to a new, higher dimension,” Hungarian Foreign Minister Peter Szijjarto said in Moscow following talks with the Russian health minister.

Szijjarto said that demand for the vaccine worldwide means Hungary has an economic interest in taking part in its production. However, neither the European Medicines Agency nor the World Health Organization have yet signed off on Sputnik V, and production issues have fanned customers’ concerns worldwide.

Officials have indicated that the Hungarian vaccine plant, located in the country’s second-largest city of Debrecen, will be completed by the end of 2022.

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SACRAMENTO, Calif. — A California judge has partially blocked an order taking effect this week that requires state prison employees to be vaccinated against the coronavirus.

A Kern County judge issued a temporary restraining order that prevents enforcement of the vaccination mandate for unionized guards.

The mandate is due to take effect Friday and it will still apply to other workers at prisons that have health care facilities The mandate is aimed at preventing another coronavirus outbreak like one that killed 28 inmates and a correctional officer at San Quentin State Prison last year.

The California Correctional Peace Officers Association opposes the measure.

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MELBOURNE, Australia — Coronavirus case numbers in Australia’s Victoria state have surged to 2,297, the highest daily infections in the country since the pandemic began last year.

But officials said Thursday the state will open up from pandemic restrictions as planned when the 70% double dose vaccination rates for people age 16 and older are reached sometime next week.

State Premier Daniel Andrews says the case numbers will be “less relevant” once the vaccination target is reached.

Officials said that 11 COVID-19 deaths were also recorded in the latest 24-hour period.

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SEOUL, South Korea — South Korea has reported more than 1,000 new coronavirus infections for the 100th consecutive day as a delta-driven outbreak continues to spread in the greater capital area.

Health officials say 1,580 of the 1,940 new cases reported Thursday are in the Seoul metropolitan region.

The capital area has been under South Korea’s toughest social distancing measures short of a lockdown since July. Private social gatherings of three or more people are banned after 6 p.m. unless all participants are fully vaccinated.

Officials say people’s frustration with social distancing is becoming an increasing challenge and hope the improving vaccination rate will allow more flexible measures soon.

As of Thursday morning, around 61% in the population of more than 51 million were fully vaccinated.

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SAN DIEGO — Beleaguered business owners and families separated by a nonessential travel ban are celebrating after the Biden administration says it will reopen U.S. land borders next month.

Travel across land borders from Canada and Mexico has been largely restricted to workers whose jobs are deemed essential. New rules will allow fully vaccinated foreign nationals to enter the U.S. regardless of the reason starting in early November.

Unlike air travel, for which proof of a negative COVID-19 test is required before boarding a flight to enter the U.S., no testing will be required to enter the U.S. by land or sea, provided the travelers meet the vaccination requirement.

The 19-month coronavirus restrictions had economic, social and cultural impact, preventing shopping and cross-border family gatherings when relatives live on different sides of the border.

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BUCHAREST, Romania — Doctors in Bucharest issued an open letter titled “a cry of despair” as the country’s overwhelmed health care system copes with record cases, hospitalizations and deaths.

The College of Physicians of Bucharest wrote a letter addressed to Romanians that says the medical system has “reached the limit.”

On Wednesday, Romania confirmed 15,733 new infections and 390 deaths, bringing the total number of deaths to 40,461. Data from health authorities indicate that more than 90% of coronavirus patients who died last week were unvaccinated.

Hungary has agreed to provide care to several dozen COVID-19 patients from Romania in the coming days to help ease the burden on hospitals.

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GENEVA — The World Health Organization says the number of global coronavirus cases fell in the last week, continuing a downward trend that began in late August.

In its latest weekly assessment of the pandemic published on Wednesday, the U.N. health agency says there were about 2.8 million new cases and 46,000 confirmed deaths in the last week, a drop of 7% and 10% respectively. Europe reported a 7% rise in cases, while all other world regions reported a decrease.

WHO says Europe also had the biggest rise in deaths in the previous week, with 11% more COVID-19 deaths. WHO says the highest numbers of new cases in Europe were reported in Britain, Turkey and Russia.

The biggest drops in cases came in Africa and the Western Pacific, where case numbers fell by 32% and 27%, respectively. Deaths in both regions fell by more than a third.

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By The Associated Press 15 October 2021, 12:00AM
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