The European Medicines Agency recommended conditional approval for a coronavirus vaccine developed by BioNTech and Pfizer to be used across the European Union.
Following a closed-doors expert meeting Monday, the EU drug regulator said it was recommending the shot be licensed for use in people over 16 years of age, with some exceptions. The pharmaceutical companies will need to submit followup data on their vaccine for the next year.
"This is really a historic scientific achievement," said Emer Cooke, the head of the agency. "It is a significant step forward in our fight against the pandemic."
The approval needs to be rubber-stamped by the EU's executive branch on Monday evening.
European Commission President Ursula von der Leyen tweeted that the EMA's approval was decisive moment.
It’s a decisive moment in our efforts to deliver safe & effective vaccines to Europeans!<br><br>The <a href="https://twitter.com/EMA_News?ref_src=twsrc%5Etfw">@EMA_News</a> just issued a positive scientific opinion on the <a href="https://twitter.com/hashtag/BioNTech?src=hash&ref_src=twsrc%5Etfw">#BioNTech</a> / <a href="https://twitter.com/pfizer?ref_src=twsrc%5Etfw">@pfizer</a> vaccine.<br><br>Now we will act fast. I expect a <a href="https://twitter.com/EU_Commission?ref_src=twsrc%5Etfw">@EU_Commission</a> decision by this evening.
—@vonderleyenAuthorities in Germany and several other European countries have said they hope to begin vaccinating people on Dec. 27.
"Today is a particularly personal and emotional day for us at BioNTech," said Ugur Sahin, the company's chief executive and co-founder. "Being in the heart of the EU, we are thrilled to be one step closer to potentially delivering the first vaccine in Europe to help combat this devastating pandemic."
"We are standing by ready to start the delivery of initial vaccine doses across the EU as soon as we get the green light," Sahin said.
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 originally set Dec. 29 as the date for its evaluation of the vaccine made by Germany-based BioNTech, but moved up the meeting to Monday after calls from the German government and other countries for the agency to move more quickly.
The vaccine has already been given some form of regulatory authorization in at least 15 countries, including Canada.
Britain and the U.S. authorized the vaccine to be used according to emergency provisions, meaning the shot is an unlicensed product whose temporary use is justified by the pandemic that has killed almost 1.7 million people worldwide to date, according to a tally by Johns Hopkins University.
Health Canada said its approval was made under an interim order that allowed it to "assess information submitted by the manufacturer as it became available during the product development process, while maintaining Canada's high standards."
"Canadians can feel confident that the review process was rigorous and that we have strong monitoring systems in place," the health agency said in a Dec. 9 statement announcing the authorization of the Pfizer-BioTech vaccine.
In a statement last week that appeared to address concerns by some in Europe about the speed of the process, the EMA 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.
Scientists are still waiting for more long-term followup data to see how long immunity from the vaccines lasts and if there are any rare or serious side-effects. Final testing of the vaccine is still ongoing. More information on whether the shot works in children is needed, in addition to its effects in pregnant women.
The vaccine is not made with the coronavirus itself, meaning there's no chance anyone could catch it from the shots. Instead, the vaccine contains a piece of genetic code that trains the immune system to recognize the spiked protein on the surface of the virus.
On the day Britain began its vaccination campaign, authorities warned people with severe allergies not to get the shot after two people suffered serious allergic reactions; it's unclear if the reactions were caused by the immunization.
The U.S. Centers for Disease Control and Prevention said that as of Friday they had seen six cases of severe allergic reaction out of more than 250,000 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 EMA plans to hold a meeting on Jan. 12 to decide if the coronavirus vaccine made by Moderna should be licensed. It has reviews ongoing for a shot developed by Oxford University and AstraZeneca and another from Janssen, but neither of those have made a formal request for the EMA to approve their vaccine.
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, Saudi Arabia shut its land and sea borders late on Sunday and suspended international commercial flights temporarily over fears of a new coronavirus strain, but foreign flights already in the country can leave, the Interior Ministry said.
Fellow Gulf Arab state Oman will close its land, air and sea borders for one week starting Tuesday, state television reported on Monday.
In Kuwait, the civil aviation authority added the United Kingdom to its high-risk list of countries on Sunday, meaning all flights from it are banned.
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.
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2020-12-21 15:14:00Z
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