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The EU drug regulator moved forward the day of its decision for the Pfizer-BioNTech coronavirus vaccine under pressure from Germany, meaning vaccinations in the bloc could begin by the end of the year.
The announcement by the Amsterdam-based European Medicines Agency that it will meet on December 21 instead of December 29 to decide whether to authorize the injection, followed a growing backlash from desperate EU countries.
Europe has lagged behind after Britain, the former home of the EMA, became the first country in the world to grant emergency approval for the vaccine, quickly followed by the United States, Canada, Singapore and Bahrain.
The EMA said in a statement that it had received “additional data” from the company on Monday that was requested by the EMA committee that examines drugs for human use.
“An exceptional meeting of the (committee) has been scheduled for December 21 to conclude if possible,” the EMA said in a statement.
The EMA added that it would reach its decision “only once the data on the quality, safety and effectiveness of the vaccine are robust and complete enough to determine whether the benefits of the vaccine outweigh its risks.”
The agency did not announce any changes to the scheduled January 12 date to make a decision on the Moderna vaccine.
The head of the European Commission, Ursula von der Leyen, welcomed the announcement, saying it meant vaccines would likely start before the end of the year.
Every day counts: we work at full speed to authorize # COVID-19 vaccines that are safe and effective.
I welcome @EMA_News moving forward their meeting to discuss the vaccine @ pfizer / BioNTech, before Christmas.
The first Europeans are likely to be vaccinated before the end of 2020!
– Ursula von der Leyen (@vonderleyen) December 15, 2020
Germany had previously lobbied the EMA, saying it wanted it to approve the vaccine “before Christmas.”
“The goal is to get approval before Christmas,” German Health Minister Jens Spahn told a news conference in Berlin. “We want to start vaccinating in Germany before the end of the year.”
Berlin had added its weight to previous orders led by Hungary and Poland for the EMA to move faster.
Then the pressure mounted a summit of EU leaders last week.
Polish Prime Minister Mateusz Morawiecki said he had urged the EMA to grant authorization “as quickly as possible”, adding that “various European leaders” backed him.
He demanded that the agency advance the day of its decision, adding: “Every day counts, every day means huge human losses, new infections, huge losses for the economy.”
Italy joined the growing clamor, and Health Minister Roberto Speranza said Tuesday that he hoped the EMA “could approve the Pfizer BioNTech vaccine ahead of schedule.”
Criticism of the EMA was further fueled by an agency hack announced in early December, in which data was taken on the Pfizer-BioNTech and Moderna vaccines.
The agency had previously said that the reason Britain, the United States and Canada moved faster was that they approved short-term emergency use without a license, while it is going to get a one-year conditional license for the vaccine.
He insisted that staff work around the clock to study laboratory data and the results of large clinical trials as they arrive.
“While speed is paramount, safety is our number one priority. These vaccines will be administered to millions of people in the EU and we are well aware of the enormous responsibility we have,” EMA chief Emer Cooke told MEPs last week.
The Irishwoman, who only took over the reins of the agency a month ago, added, however, that the goal was also to ensure the launch of the vaccine in all 27 EU countries at the same time.
“This means that all member states, large or small, will benefit from joint work carried out at EU level and that all member states can start preparing for vaccine campaigns,” he said.
Coronavirus affects 47% of migrant workers in Singapore dormitories
Nearly half of Singapore’s migrant workers residing in dormitories have had Covid-19, according to the government, indicating that the virus has spread much more in those dormitories than the official count shows.
Singapore has reported more than 58,000 coronavirus cases since the pandemic began, with the vast majority occurring in crowded dormitories that house mostly low-wage workers from South Asia.
But the government said today that while 54,505 workers tested positive for the virus using polymerase chain reaction (PCR) tests, another 98,289 tested positive using serological tests.
PCR tests diagnose current or new infections and serological tests indicate a past infection.
The prevalence rate of Covid-19 in bedrooms is currently 47%, including the results of serological tests.
The prevalence rate of the virus in the Singapore population as a whole was around 0.25% according to a serology sampling study of 1,600 people, according to a health ministry official.
Meanwhile, Singapore said today that it will open a new segregated travel route for a limited number of business, official and high-value travelers from all countries, as part of efforts to revive its key travel and hospitality sectors.
1.5 million positive cases in Argentina
Argentina has registered 1.5 million cases of coronavirus, making it the ninth country in the world to reach the milestone.
The Latin American nation has managed to stem an explosion of cases, which reached a peak of 18,326 confirmed daily cases in October. There was a steady decline in the number of cases in recent weeks to 5,062 confirmed today.
The Argentine Ministry of Health said that so far there have been 1,503,222 people infected with Covid, with 41,041 deaths.
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China records 17 new infections
Mainland China reported 17 new cases of Covid-19 in the past 24 hours, up from 16 cases the day before, the country’s national health authority said today.
The National Health Commission, in a statement, said that 14 of the new cases were imported infections originating from abroad.
Three other cases of local transmission were also reported, two in Heilongjiang province and one in Sichuan.
The number of new asymptomatic cases, not classified by China as confirmed cases, fell to eight from nine the day before.
The total number of confirmed Covid-19 cases in China now stands at 86,758. The death toll is unchanged at 4,634.
Social distancing plea to South Koreans
South Korean Prime Minister Chung Sye-kyun has pleaded with residents to abide by social distancing rules to avoid further restrictions in the face of the country’s biggest wave of coronavirus infections.
Daily infection rates remain at record levels with an additional 880 new cases reported as of midnight last night, up from 718 the day before, the Korea Agency for Disease Prevention and Control said.
The government is reluctant to impose the toughest Level 3 restrictions because of the “irrevocable pain” it would cause, Chung said.
Companies could allow only essential workers in offices and gatherings of more than 10 people would be prohibited under such a shutdown.
Japanese poll on the cancellation of the Tokyo Games
A third of Japanese residents want the Tokyo Olympics removed amid fears that an influx of foreign arrivals could cause a further spike in Covid-19 cases, a survey by public broadcaster NHK showed today.
The Japanese government and the International Olympic Committee (IOC) decided in March to postpone the 2020 Olympics for one year due to the pandemic, and the Games will now be held from July 23 to August 8, 2021.
But as Japan grapples with a third wave of infections, the NHK survey showed that 32% of those surveyed wanted the Summer Olympics canceled altogether.
Only 27% said it should go ahead as scheduled, while 31% favored another delay.
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