The Latest: European Medicines Agency reviews COVID-19 drug
AMSTERDAM — The European Medicines Agency said it has begun an expedited approval process for a combination COVID-19 drug that was granted an emergency use authorization in the U.S. in November.
In a statement on Monday, the EU regulator said it has started a “rolling review” of the drug known as REGN-COV2, developed by Regeneron Pharmaceuticals and Roche. It is made of casirivimab and imdevimab, two monoclonal antibodies.
The Amsterdam-based EMA said its decision was based on preliminary results from a study that suggests the drug could reduce the amount of virus in the blood, but said “it is too early to draw any conclusions.” It said it was evaluating the first batch of data on the drug, from laboratory and animal studies and that further data from clinical trials would be assessed as they become available.
The drug was administered to former U.S. President Donald Trump when he was hospitalized with COVID-19 last year and was authorized by the U.S. Food and Drug Administration for children and adults with mild to moderate coronavirus. The drug is given in an intravenous infusion.
THE VIRUS OUTBREAK:
— AstraZeneca to send European Union 9 million more doses this quarter, tamping down huge public spat
— Vaccine skepticism lurks in Tuskegee, Alabama, known for syphilis study
— WHO team in Wuhan visits provincial disease control center
— Thousands flout virus restrictions at funerals in Israel
— Even if schools reopen by late April, millions of students, many of them minorities in urban areas, may be left out
Follow all of AP’s pandemic coverage at https://apnews.com/hub/coronavirus-pandemic, https://apnews.com/hub/coronavirus-vaccine and https://apnews.com/UnderstandingtheOutbreak
HERE’S WHAT ELSE IS HAPPENING:
LINCOLN, Neb. — Nebraska Gov. Pete Ricketts was self-isolating from the public on Monday after he was exposed to a person over the weekend who showed symptoms of the coronavirus.
Ricketts said he was near the person for longer than 15 minutes on Saturday. He had been scheduled Monday to participate in the Governor’s Annual Wellness Walk around the Capitol to promote fitness, but spoke to reporters instead through a video-conferencing link.
Ricketts said the person who showed coronavirus symptoms is getting tested for the virus and still awaiting results. He said his contact with the person, who he didn’t identify, was for business and not a social gathering.
The Republican governor was also forced to go into quarantine in November after he and Nebraska first lady Susanne Shore were exposed to an infected person during a weekend dinner gathering.
PRAGUE — The Czech Republic is not planning to limit use of the AstraZeneca coronavirus vaccine for elderly people like some other European Union nations.
Health Minister Jan Blatny says “we can see no reasons for us to think the vaccine cannot be used for people above any certain age.”
Italy is planning to administer the vaccine developed with the Oxford University for people aged 18 – 55 while German authorities don’t recommend it for those aged 65 and older.
Blatny say says vaccines in general are less effective for older people. The European Union approved the vaccine without any age limits.
GENEVA — Officials at the World Health Organization pushed back against suggestions that the U.N.-led team investigating the origins of the pandemic in China is not getting enough access or data during its ongoing visit to Wuhan.
WHO’s COVID-19 technical lead Maria Van Kerkhove said the team, comprised of experts from 10 countries, has plans to visit the Wuhan Institute of Virology, among other sites.
“We need to give them the space to be able to carry out this scientific study,” she said, in response to suggestions that China has been less than transparent about how the outbreak began. WHO’s team arrived in Wuhan last month after a months-long delay to investigate the animal origins of COVID-19.
Dr. Michael Ryan, WHO’s emergencies chief, said the agency was continuing to ask for more data and said anyone with information about how the pandemic started should share it with the organization.
SAN FRANCISCO — An effort to reopen schools in California is foundering, stoking the frustration of parents and the governor of America’s most populous state.
While Texas, Florida and New York are among states that have resumed some classroom instruction, California’s 10,000 public schools have for the most part been closed since March. As the one-year anniversary of distance learning approaches, parents are grappling more than ever with the toll of isolation and intense screen time on their kids’ academic and emotional well-being.
A $2 billion plan by Gov. Gavin Newsom to reopen schools next month has not been well received. The Legislature shows no sign of fast-tracking its approval. The state’s powerful teachers unions and biggest school districts say it is unworkable, raising questions about whether K-12 schools will open at all this academic year.
TOKYO — Japanese Prime Minister Yoshihide Suga told reporters Monday that the number of new cases has decreased since early January when he placed Tokyo and 10 other prefectures under a state of emergency, but Japan needs to keep the guards up high for a while.
Suga is expected to announce an extension of the state of emergency, currently set to end on Saturday, for another month until March 7 after experts cautioned that lifting of the measures too soon would trigger a resurgence of the infections.
Suga said he will convene a taskforce meeting Tuesday to get experts’ advise before making a decision.
Japan as of Sunday had nearly 390,000 cases and more than 5,700 deaths.
WASHINGTON — White House coronavirus adviser Andy Slavitt says the government awarded a $231-million contract to scale up production of a COVID-19 home test recently authorized by U.S. regulators.
For months, health experts have stressed the need for fast, widespread home testing so that people can screen themselves and avoid contact with others if they have an infection. But the vast majority of tests still require a nasal swab performed by a health worker that must be processed at high-tech laboratories.
The test kit from Australian manufacturer Ellume allows users to swab themselves at home and check their status in about 20 minutes. It’s one of only three tests that consumers can use themselves, and the only one available without a doctor’s prescription.
Ellume said Monday it would use the contract to construct a U.S. manufacturing plant and deliver 8.5 million tests for federal use. It did not specify a timeframe for delivery.
Also on Monday at the White House coronavirus briefing, the head of the Centers for Disease Control and Prevention said new COVID-19 cases and hospitalizations are down in recent weeks, but three mutations that are causing concern have been detected in the U.S.
Dr. Rochelle Walensky said most of the dozens of U.S. cases of coronavirus mutations, or variants, involve the strain first detected in the United Kingdom. But three cases involving a worrisome mutation first detected in South Africa have also been confirmed, as well as one case involving a strain first detected in Brazil.
ROYAL OAK, Mich. — A Detroit-area health care system says about 2,700 people were able to use an online scheduling vulnerability to register out-of-turn for COVID-19 vaccinations.
Beaumont Health says it has determined a user publicly shared an unauthorized pathway for scheduling that allowed 2,700 people to “cut in line.” Beaumont is canceling all the appointments that used the unauthorized pathway.
Individuals who scheduled an appointment that way will be notified via email that their appointment has been canceled. Beaumont’s information technology team detected and shut down unusual activity Saturday on its Epic electronic medical record system.
SAN JUAN, Puerto Rico — Puerto Rico’s Health Department announced Monday that it will turn its COVID-19 vaccine efforts solely to those 65 and older, suspending shots for emergency responders.
Health Secretary Carlos Mellado said the new policy will be in effect for the next four weeks.
The U.S. territory already has vaccinated more than 250,000 people, starting with medical workers and then emergency workers.
The Health Department also put a halt to vaccinations for the U.S. territory’s elections commission, saying it had not been authorized.
The department said vaccination of emergency responders will resume once the elderly have received their shots.
ROME — Much of Italy is gingerly reopening from pre-Christmas coronavirus closures, with the Vatican Museums welcoming a trickle of visitors to the Sistine Chapel and locals ordering their cappuccinos at outdoor tables.
While many European countries remain in hard lockdowns amid surging COVID-19 infections and variants, most Italian regions graduated to the coveted “yellow” category of risk starting Monday. That has allowed museums to reopen, sit-down restaurant and bar service to resume and many high-schoolers to return to class.
In Rome, that meant that the Vatican Museums reopened for the first time in 88 days — it’s longest closure ever. Museum director Barbara Jatta said staff took advantage of the weekslong closure to rearrange some exhibit halls and do maintenance work that would otherwise be difficult to complete with the nearly 7 million visitors who normally flock to see Michelangelo’s “Last Judgment” and Raffael masterpieces each year.
SARAJEVO, Bosnia-Herzegovina — Bosnian Serb health authorities say that 2,000 Russian Sputnik V vaccines have arrived in the pro-Russian, Serb-dominated half of the country, in what is the first shipment of any vaccines to the Balkan nation.
Alen Seranic, the Health Minister of Republika Srpska, which is how the Serb-run Bosnian entity is called, says the vaccines have landed in the Bosnian capital of Sarajevo for approval by the country’s medical agency.
Bosnia’s Serbs have close political ties with Russia. The second entity, run by the country’s predominantly Muslim Bosniaks and Croats, has announced first shipments of Western-made vaccines later this month.
The country remains ethnically divided years after the 1992-95 war. A U.S.-brokered peace deal created the two entities connected loosely in a joint central government.
Seranic says health staff working with COVID-19 patients will be the first in line for vaccination. He says additional 400,000 Russian vaccines should arrive in the next two months.
JERUSALEM — Israel says it has shipped the first batch of the Moderna vaccine to the Palestinians.
The unit for Coordination of Government Activities in the Territories, or COGAT, said Monday that it coordinated a first shipment of 2,000 doses out of 5,000 doses for use by medical teams under the Palestinian Authority.
The transfer at Beituniya Crossing took place a day after Israeli Defense Minister Benny Gantz’s office announced the vaccinations had been approved for Palestinians. Israel is leading one of the world’s most successful vaccination campaigns after securing millions of doses from major drug makers Pfizer and Moderna.
International human rights groups and U.N. experts have said Israel is responsible for the well being of Palestinians living in the occupied West Bank and Gaza Strip.
Israel denies it has such an obligation. The Palestinians have not publicly requested vaccines from Israel.
THE HAGUE, Netherlands — The European Union’s police agency is warning nations to be on the lookout for fake COVID-19 test certificates, as crime gangs attempt to cash in on pandemic travel restrictions.
Many countries have introduced requirements for arriving passengers to show a negative COVID-19 test to slow the spread of the coronavirus brought in by people arriving from other nations.
Europol said Monday that recent cases reported by EU member states include a forgery ring selling negative test results to passengers at the Charles de Gaulle airport in Paris and a counterfeiter detained by Spanish police for selling fake test results.
British authorities also caught fraudsters selling COVID-19 documents for 100 pounds ($137) each.
RAMALLAH, West Bank — The World Health Organization says the Palestinian Authority will begin receiving tens of thousands of coronavirus vaccines later this month pending agreements with manufacturers and regulatory approval.
The WHO said Monday that the PA would receive 37,440 doses of the Pfizer-BioNTech vaccine from mid-February “subject to approvals of supply agreements with manufacturers.” Those would go to frontline medical workers. It says the PA would receive another 240,000 to 405,600 AstraZeneca vaccine doses from mid- to late February subject to WHO emergency use approval.
The vaccines are being provided through COVAX, a WHO program to help poor countries acquire vaccines.
Palestinian Prime Minister Mohammad Shtayyeh told a Cabinet meeting Monday that vaccinations would begin later this month with the arrival of 50,000 doses, mostly purchased through COVAX.
JOHANNESBURG — South Africa has acquired 20 million doses of the Pfizer vaccine that are expected to arrive in the second quarter of the year, the government has confirmed.
The purchase is a significant boost to the government’s efforts to acquire vaccines to reach its goal of inoculating 40 million people, representing 67% of the country’s population, this year.
The cost of the Pfizer vaccines will be announced at a later date by Minister of Health Zweli Mkhize, said Lwazi Manzi, spokeswoman for the health ministry.
South Africa is eagerly awaiting the arrival Monday of its first delivery of vaccines, 1 million doses of the AstraZeneca vaccine from the Serum Institute of India. That will be followed up by another 500,000 doses later this month. Those AstraZeneca vaccines will be used to inoculate frontline health workers.
In the coming months, South Africa is expecting to receive 6 million vaccine doses from the international COVAX facility, 9 million of the Johnson & Johnson vaccine when it is approved, and an additional 20 million from the African Union’s vaccine acquisition task team.
CANBERRA, Australia — Australia’s prime minister says he expects all Australians will have been offered a free COVID-19 vaccine by October, but has no timeline yet for sharing vaccines with Southeast Asian and South Pacific island neighbors.
Australia last month approved the Pfizer vaccine and expects to start vaccinating in late February.
Prime Minister Scott Morrison told the National Press Club of Australia that his government has secured 140 million vaccine doses, enough to cover its population of 26 million “several times over.”
He said Foreign Minister Marise Payne and Minister for International Development and the Pacific Zed Seselja were working with the leaders of Australia’s developing neighbors to share vaccines.