The European Medicines Agency is meeting Monday to consider approving a coronavirus vaccine developed by BioNTech and Pfizer that would be the first to be authorized for use in the European Union.
The closed-doors meeting comes weeks after the shot was granted permission under emergency provisions by regulators in Britain and the United States.
If EMA scientists conclude that the vaccine is safe, officials at the Amsterdam-based agency are expected to give conditional approval for it to be used across the 27-nation bloc. The European Commission must still rubber-stamp the decision before the vaccine can be rolled out, a process German officials say could begin Dec. 27. The pharmaceutical companies will also need to submit follow-up data on their vaccine for the next year.
The European regulator came under heavy pressure last week from countries calling for the vaccine to be granted approval for use as quickly as possible. EMA had originally set Dec. 29 as the date for its evaluation of the vaccine made by Germany-based BioNTech, but moved the meeting forward after calls from Berlin and others to move quicker.
The vaccine has already been given some form of regulatory OK in more than a dozen countries, including Canada, the U.S. and the United Kingdom.
The EMA approval is largely similar to the normal licensing procedure that would be granted to any new vaccine, only on an accelerated schedule.
In a statement last week, the agency stressed that the vaccine would only be approved after a scientific assessment showed its overall benefits outweighed the risks.
“A vaccine’s benefits in protecting people against COVID-19 must be far greater than any side effect or potential risks,” it said.
So far, the U.S. Centers for Disease Control and Prevention says they have seen six cases of severe allergic reaction out of more than a quarter-million shots of the BioNTech-Pfizer vaccine given, including in one person with a history of vaccination reactions.
BioNTech and Pfizer offered the EU 400 million doses of the vaccine, but the bloc’s executive Commission chose to buy only 200 million doses, with an option for 100 million more.
The European Centre for Disease Prevention and Control, meanwhile, said “timely efforts” to prevent and control the spread of cases of COVID-19 involving the new coronavirus variant observed in Britain are needed, but infections have already been reported in at least three other countries in Europe.
The Stockholm-based agency said in a “threat assessment” Monday that while preliminary analysis in the U.K. suggests the new variant is “significantly more transmissible” there is no indication that infections are more severe.
ECDC said a few cases with the new variant have been reported already by Iceland, Denmark and the Netherlands. It also cited media reports of cases in Belgium and Italy.
What’s happening across Canada
As of 7:30 a.m. ET on Monday, Canada’s COVID-19 case count stood at 507,795 with 76,859 of those cases considered active. A CBC News tally of deaths based on provincial reports, regional health information and CBC’s reporting stood at 14,228.
Ontario Premier Doug Ford is set to address the public Monday afternoon after sources said the entire province will be sent into lockdown on Dec. 24. The province — which as of Sunday had 875 COVID-19 patients in hospital, including 261 in intensive care units — has seen six days straight with more than 2,000 daily cases of COVID-19.
What’s happening in the U.S.
U.S. congressional leaders reached agreement on Sunday on a $900 billion US package to provide the first new aid in months to an economy and individuals battered by the surging coronavirus pandemic, with votes likely on Monday.
The package would be the second-largest economic stimulus in U.S. history, following a $2.3 trillion aid bill passed in March. It comes as the pandemic accelerates, infecting more than 214,000 people in the country each day. More than 317,000 Americans have already died.
The package would give $600 direct payments to individuals and boost unemployment payments by $300 a week. It also includes billions for small businesses, food assistance, vaccine distribution, transit and health care. It extends a moratorium on foreclosures and provides $25 billion in rental aid.
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The United States is monitoring the new strain of COVID-19 emerging in Britain, multiple U.S. officials said, adding that it was unclear whether the mutated variant had made its way to the U.S.
What’s happening around the world
As of early Monday morning, more than 76.9 million cases of COVID-19 had been reported around the world with more than 43.3 million of those cases considered recovered or resolved, according to a coronavirus tracking tool maintained by Johns Hopkins University. The global death toll was approaching 1.7 million.
In Africa, South Africa announced that a new variant of the COVID-19 virus is driving the country’s current resurgence of the disease, which is seeing higher numbers of confirmed cases, hospitalizations and deaths.
The new variant, known as 501.V2, is dominant among new confirmed infections in South Africa, according to health officials and scientists leading the country’s virus strategy.
“It is still very early but at this stage, the preliminary data suggests the virus that is now dominating in the second wave is spreading faster than the first wave,” Prof. Salim Abdool Karim, chair of the government’s ministerial advisory committee, said in a briefing to journalists.
South Africa may see “many more cases” in the new wave than it experienced in the first surge of the disease, said Abdool Karim.
South Africa currently has more than 8,500 people hospitalized with COVID-19, surpassing the previous high of 8,300 recorded in August.
“We are seeing a much earlier and much sharper rise in the second wave or resurgence than we anticipated,” Prof. Ian Sanne, a member of the advisory committee, told South Africa’s News24.
The new strain, different from the one in Britain, appears to be more infectious than the original virus. South African scientists are studying if the vaccines against COVID-19 will also offer protection against the new strain.
Some of the vaccines, including the one developed by Oxford University and AstraZeneca, are undergoing clinical tests in South Africa. The scientists studying the new variant emphasized that preventive measures like wearing masks and social distancing are vital.
In response to the resurgence of COVID-19, the South African government has introduced tougher lockdown restrictions which include limited days and hours for the trade of alcohol and the closure of beaches in areas identified as hotspots.
The country has recorded a total of 912,477 cases, including 24,539 deaths.
In the Asia-Pacific region, Hong Kong will ban flights from Britain after a more infectious variant of the coronavirus was found in the country, according to the city’s top health official.
Tokyo Gov. Yuriko Koike on Monday asked all residents to celebrate Christmas and New Year at home just with their families and asked organizers to have events close early in the night.
Japan’s daily coronavirus cases have been steadily on the rise and Tokyo hit its new high at 822 last Friday. On Monday, the Japanese capital city found 392 new cases for a prefectural total of 51,838.
Thailand’s total number of confirmed coronavirus cases surged past 5,000 on Monday as hundreds of migrant workers tested positive for the disease.
Thailand has been one of several Southeast Asian countries that had been relatively unscathed by the pandemic. But on Saturday, health officials reported a daily record of 548 new cases, almost all of them among migrant workers in the seafood industry in Samut Sakhon province, about 35 kilometres southwest of Bangkok, the capital.
Thai Prime Minister Prayuth Chan-ocha said his government would wait to see how the situation looked in a week’s time before deciding on any special restrictions for New Year’s celebrations.
In the Middle East, Qatar’s Ministry of Public Health granted emergency use authorization for the vaccine developed by Pfizer and BioNTech and is due to receive the first shipment on Monday, state media reported.
The U.S. remained the hardest-hit country in the Americas, trailed by Brazil, which has seen more than 7.2 million reported cases of COVID-19 and more than 186,700 deaths.