The Latest: WHO panel OKs emergency use of Sinopharm vaccine
GENEVA — The World Health Organization has given its authorization for emergency use of a COVID-19 vaccine manufactured by China’s Sinopharm.
The decision by a WHO technical advisory group opens the possibility that the Sinopharm vaccine could be included into the U.N.-backed COVAX program in coming weeks or months and distributed through UNICEF and WHO’s regional office for the Americas.
Sinopharm has publicly released little data, aside from efficacy numbers for its two vaccine shots, one developed by its Beijing Institute of Biological Products and the other by the Wuhan Institute of Biological Products. The Beijing shot is one that was considered by WHO for an emergency use listing.
A separate group advising the U.N. agency on vaccines said it was “very confident” the Sinopharm vaccine protects the 18-59 age group but had only a “low level of confidence” of efficacy in the age 60-plus.
THE VIRUS OUTBREAK:
— WHO panel OKs emergency use of China's Sinopharm vaccine
— India cases hit new record as calls grow for strict lockdown
— Japanese impatient over virus steps; state of emergency extended in Tokyo
— Doctors in Nepal warn of major crisis as virus cases surge
HERE’S WHAT ELSE IS HAPPENING:
PORTO, Portugal — After the United States backed calls for patent waivers, French President Emmanuel Macron says the real issue facing the vaccine shortfall “is not really an intellectual property issue.”
He says: “You can give the intellectual property to laboratories that do not know how to produce it. They won’t produce it tomorrow.”
The key issues are donations and free exports, and Macron says the United States should work on that.
At an EU summit in Porto, he says says “the Anglo-Saxons block many of these ingredients. Today 100 percent of vaccines produced in the United States of America are for the American market.”
He says it contrasted sharply with the EU situation, where almost half of the doses produced on the continent have been allowed to be exported.
EU Commission President Ursula von der Leyen said this week about 200 million does had been distributed within the EU’s 27-nation bloc while about the same amount had been exported abroad.
ANKARA, Turkey — Turkish President Recep Tayyip Erdogan has spoken in favor of waiving patents for COVID-19 vaccines and vowed to “share” Turkey’s vaccines once they are available.
“Science is the property of all humanity,” Erdogan said Friday. “A logic, an understanding that says, ‘We produced this, and therefore we won’t give it to anyone’ concerning a matter that affects human health, is the wrong approach.”
Four Turkish vaccines are currently undergoing clinical trials. The country is working to develop an intranasal COVID-19 vaccine. Officials have said Turkey hopes its first vaccine is available in September or October.
Erdogan said: “We don’t aim to use these only in our country. We are prepared to share them with the world, wherever there is a demand.”
NEW YORK — Drugmaker Pfizer has begun the process to earn full U.S. regulatory approval for its COVID-19 vaccine for people aged 16 and older.
That gives Pfizer and German partner BioNTech a shot at winning the first full approval from the U.S. Food and Drug Administration.
The two companies say they’ve started a “rolling submission” of data from their studies of the two-dose vaccine, first giving the FDA data from laboratory and human testing. That includes their latest analysis from a key late-stage study that followed the participations for up to six months after they received their second dose. The companies plan to soon submit data on manufacturing quality controls and the factories making the vaccine.
Pfizer Chief Executive Albert Bourla said in a statement that the companies are aiming to win full regulatory approval “in the coming months.”
The shot received emergency use authorization from the FDA on Dec. 11. Since then, the companies have delivered more than 170 million doses across the U.S., and many more to other countries that also have authorized emergency use amid the coronavirus pandemic. Such emergency authorizations only last until countries declare an end to the emergency, so the vaccine must undergo a more stringent review by regulators to earn full approval for continued use.
Dr. Ugur Sahin, co-founder of BioNTech, said the submission “is an important cornerstone of achieving long-term herd immunity and containing COVID-19 in the future.”
The partners also applied to the FDA to expand the current emergency authorization to people ages 12 to 15. They plan to seek full approval for that age group once they have the required six months of follow-up data from the volunteers tested in that group. They’re also testing the shot in younger children and pregnant women.
LONDON — Britain says a coronavirus strain first identified in India has been labelled a “variant of concern” because it appears be more transmissible than some other variants.
Public Health England says the number of cases of the B.1.617.2 variant identified in the U.K. has increased from 202 to 520 in the past week. The majority are in northwest England and London and just over half the cases haven’t been linked to travel to India.
Health authorities say there is “insufficient evidence” so far to say whether the variant causes more severe disease or is resistant to vaccines. But they say it appears more transmissible than the original strain of the virus.
Prime Minister Boris Johnson says authorities were being “very careful” about the new strain and door-to-door “surge testing” will be carried out in areas where it was spreading.
Strains first identified in South Africa and Brazil have been designated variants of concern. The variant first identified in southeast England last year was the first to be called a “variant of concern.” It is now the dominant variant in the U.K.
However, coronavirus cases in Britain have gone down significantly since a lockdown in January, and restrictions are gradually easing. Schools, hair salons and shops are open, along with restaurants and pubs operating outdoors.
TOKYO — Japan extended its state of emergency in Tokyo and other areas through May 31.
Japan is showing social and political strains as the coronavirus spreads ahead of the Tokyo Olympics, which start in 11 weeks.
Tokyo logged 907 new cases of coronavirus infections, up sharply from 635 when the state of emergency began in the capital last month. It’s far above the target of 100 that some health experts recommend.
Most Japanese oppose hosting the Olympics during a pandemic, while the government seems determined to hold the event. However, people are growing impatient and less cooperative, which could make the measures less effective.
The president of the Tokyo Olympics organizing committee, Seiko Hashimoto, says a possible mid-May visit by International Olympic Committee President Thomas Bach has become more difficult because of the extension of the emergency. The postponed Olympics from last year are scheduled for July 23-Aug. 8.
(This item has been corrected to show Seiko Hashimoto is the president of the Tokyo Olympics. She was formerly the minister of the Olympics.)
LONDON — Britain’s vaccines regulator says people under 40 shouldn’t be given the AstraZeneca coronavirus vaccine if another shot is available because of a suspected link to very rare blood clots.
The Joint Committee on Vaccination and Immunization says people ages 30 to 39 without underlying health conditions should receive an alternative vaccine, “where available and only if this does not cause substantial delays in being vaccinated.”
Last month it gave the same advice for people under 30. Two-thirds of U.K. adults have received at least one shot of vaccine, and almost a third have had both doses. A majority have had the AstraZeneca shot, though Britain is also using vaccines made by Moderna and Pfizer-BioNTech.
British health officials say the risk from COVID-19 far exceeds any risk from the AstraZeneca vaccine for the vast majority of people.Up to April 28, Britain’s medicines regulator had received 242 reports of blood clots accompanied by low blood platelet count in people who had received the AstraZeneca vaccine, out of 28.5 million doses given. There were 49 deaths.
Most of the cases occurred after the first dose, and the vaccination watchdog says there are no concerns about people getting second AstraZeneca shots.
LONDON — The European Medicines Agency said the product information for the COVID-19 vaccine made by BioNTech and Pfizer should be modified to make doctors and patients aware that people who have previously had dermal injections could experience facial swelling after getting a dose.
The EU drug regulator says it had reviewed all available evidence and concluded that “there is at least a reasonable possibility of a causal association between the vaccine and the reported cases of facial swelling in people with a history of injections with dermal fillers.” It described dermal injections as “soft, gel-like substances injected under the skin.”
The EMA recommended facial swelling be added as a potential side effect but that its assessment of the vaccine remained unchanged and the benefits outweighed the risks.
LONDON — The European Medicines Agency says it has begun an accelerated authorization process for an experimental coronavirus treatment made by GlaxoSmithKline and Vir BioTechnology.
In a statement on Friday, the EU drug regulator said it had started a rolling review of sotrovimab, based on early results from an ongoing study into whether the treatment can prevent hospitalization or death in people who don’t yet have severe COVID-19. But EMA said it had not yet received the complete data and cautioned that “it is too early to draw any conclusions about the benefit-risk balance of the medication.”
Although the EMA has given the green light to four vaccines, there are few licensed treatments for the coronavirus, especially any that might prevent people with mild COVID-19 from progressing to severe disease.
Sotrovimab is a monoclonal antibody, a lab-produced antibody that is intended to stimulate the immune system by reducing the ability of the coronavirus’s spike protein to enter the body’s cells.
An emergency use authorization for sotrovimab has also been submitted to regulators in the U.S. and Canada.
ROME — The head of the World Trade Organization says the U.S. administration’s call to remove patent protections on COVID-19 vaccines will give an impetus to negotiations to resolve access inequity but that the decision in and of itself won’t resolve the problem.
WTO Director-General Ngozi Okonjo-Iweala told a virtual conference Friday that the WTO was aiming to find a “pragmatic solution that assures access to developing countries to deal with vaccine inequity, whilst at the same time making sure we don’t disincentivize research and innovation.”
In remarks to the Florence-based European University Institute’s annual State of the Union conference, Okonjo-Iweala, a Nigerian economist, said the patent waiver “may not be the critical issue” on increasing vaccine volume.
Other key steps include reducing export restrictions and prohibitions for both final products and raw materials, as well as training manufacturing personnel and increasing manufacturing capacity globally.
She noted that 80 percent of the world’s exports of vaccines is concentrated in 10 countries in North America, South Asia and Europe, and that Africa imports 99 percent of its vaccines. She said: “We are seeing the problems with that concentration now.”
THE HAGUE, Netherlands — Dutch authorities have seized the bank accounts of hundreds of businesses that are suspected of fraudulently claiming government coronavirus financial support.
The Netherlands Enterprise Agency announced Friday that prosecutors have filed cases against companies accusing them of abuse or dishonest use of a scheme in which the government contributes to rent payments and other recurring business costs.
It was not immediately clear how much money has been fraudulently claimed.
The enterprise agency says it has seized bank accounts as a way of clawing back wrongly claimed payments.
The Dutch government has pumped billions of euros into propping up companies ranging from national carrier KLM to small businesses that have been hit by the coronavirus and lockdown measures.
HONG KONG — Hong Kong health officials say quarantine rules for inoculated travelers arriving in Hong Kong from low- and medium-risk countries will be relaxed.
Inbound travelers who have been fully vaccinated from low-risk countries like Australia, New Zealand and Singapore will only need to undergo seven days quarantine in a hotel, down from 14 days previously. They will also need to take two coronavirus tests after their quarantine.
Those coming from medium-risk countries, such as Malaysia or Vietnam, will have their quarantines reduced to 14 days, from 21 days. Arrivals from high-risk countries, such as the U.S., Britain and other European countries like Germany or France will still have to undergo three weeks of quarantine, regardless of their vaccination status.
The new measures will take effect from May 12.
Hong Kong is seeking to boost its slower-than-expected vaccination rates in the city. Hong Kong has so far only vaccinated about 13.6% of its population, amid public distrust of the largely pro-Beijing government and concerns over side effects.
On Friday, officials also announced the reduction of quarantine periods for close contacts of coronavirus patients who have been fully vaccinated.
BERLIN — Germany’s health minister has welcomed a decline in new COVID-19 cases, but says Germans need to endure “weeks or a few months” of restrictions.
Germany’s seven-day rolling average of daily new cases declined over the past two weeks, from almost 25 cases per 100,000 people on April 22 to 19 cases per 100,000 people on May 6.
Health Minister Jens Spahn said Friday that efforts to reduce social contacts and travel had helped push down the number of infections in recent weeks.
He also cited the rapid increase in vaccinations in the country.
Spahn said about 26.2 million people, or about 31.5% of the German population, have received at least one dose of vaccine. Almost 9% have received two shots.
He warned against reopening some areas of public life too quickly however, warning that “this bears a risk.”
Some of Germany’s 16 states have begun allowing limited tourism and outside dining again.
Germany’s disease control agency reported 18,485 newly confirmed cases Thursday, and 284 deaths. Since the start of the outbreak, Germany has recorded almost 3.5 million confirmed cases and 84,410 deaths.
CANBERRA, Australia — Australia’s prime minister say an India travel ban will end with three government-chartered flights to repatriate Australians by the end of May.
The government has resisted mounting pressure to lift the travel ban imposed last week until May 15 to reduce infections in Australian quarantine facilities.
Prime Minister Scott Morrison said the 900 Australians listed as vulnerable would be given priority among the 9,000 citizens registered with authorities as wanting to come home from India.
But Australians would have to provide a negative result to a rapid antigen COVID-19 test before they could board a flight.
“I’m sure that’s what all Australians would expect,” Morrison said.
The flights would end at a quarantine facility outside the northern city of Darwin. The government had yet to make a decision on when normal commercial flights from India would resume.