The European Medicines Agency recommended conditional approval for a coronavirus vaccine developed by BioNTech and Pfizer to be used across the European Union, weeks after the shot was first granted permission under emergency provisions in Britain and the United States.
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 follow-up 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. a move its chief said is likely to happen Monday evening.
European Commission President Ursula von der Leyen tweeted that the EMA's approval was “a decisive moment in our efforts to deliver safe & effective vaccines to Europeans!”
“Now we will act fast. I expect a @EU_Commission decision by this evening,” she said. The EU’s executive arm had been expected to require two or three days to approve the EMA’s decision.
Authorities 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 European Medicines Agency met Monday to consider approving a coronavirus vaccine developed by BioNTech and Pfizer that would be the first to be authorised for use in the European Union. AP Photo
The vaccine has already been given some form of regulatory authorization in at least 15 countries.
Britain, Canada and the US authorised 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.
Switzerland became the first country Saturday to authorize the Pfizer/BioNTech vaccine according to the normal licensing procedure. EMA approval also follows the regular process, only on an accelerated schedule and under the condition that the pharmaceutical companies submit follow-up data on their vaccine for the next year.
In a statement last week that appeared to address concerns by some in Europe about the speed of the process, the agency stressed that the vaccine would only be approved after a scientific assessment showed its overall benefits outweighed the risks.
Also Read- Europe an epicenter of COVID-19 right now
“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 follow-up 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 immunisation.
A man walks past a closed shop on Regent Street in central in London, Sunday, Dec 20, 2020. AP photo
The US Centers for Disease Control and Prevention said that as of Friday they had 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 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.
A growing list of European Union nations and Canada barred travel from the U.K. on Sunday and others were considering similar action, in a bid to prevent a new strain of coronavirus sweeping across southern England from spreading to the continent.
France, Germany, Italy, the Netherlands, Belgium, Austria, Ireland and Bulgaria all announced restrictions on U.K. travel, hours after British Prime Minister Boris Johnson announced that Christmas shopping and gatherings in southern England must be canceled because of rapidly spreading infections blamed on the new coronavirus variant.
Johnson immediately placed those regions under a strict new Tier 4 restriction level, upending Christmas plans for millions.
Also read: Global Covid-19 cases surpass 76.2 million
France banned all travel from the U.K. for 48 hours from midnight Sunday, including trucks carrying freight through the tunnel under the English Channel or from the port of Dover on England's south coast. French officials said the pause would buy time to find a “common doctrine” on how to deal with the threat, but it threw the busy cross-channel route used by thousands of trucks a day into chaos.
The Port of Dover tweeted Sunday night that its ferry terminal was “closed to all accompanied traffic leaving the UK until further notice due to border restrictions in France.”
Eurostar passenger trains from London to Paris, Brussels and Amsterdam were also halted.
Germany said all flights coming from Britain, except cargo flights, were no longer allowed to land starting midnight Sunday. It didn’t immediately say how long the flight ban would last. Belgian Prime Minister Alexander De Croo said he was issuing a flight ban for 24 hours starting at midnight “out of precaution.” “There are a great many questions about this new mutation,” he said, adding he hoped to have more clarity by Tuesday.
Canada announced its own ban Sunday night. Prime Minister Justin Trudeau said in a statement that for 72 hours starting at midnight Sunday, “all flights from the UK will be prohibited from entering Canada.” He added that travelers who arrived Sunday would be subject to secondary screening and other health measures. A follow-up statement from the government said cargo flights were not included in the ban.
The British government said Johnson would preside at a meeting of the government's crisis committee, COBRA, on Monday in the wake of the other nations' measures. They come at a time of huge economic uncertainty for the U.K., less than two weeks before it leaves the EU's economic structures Dec. 31, and with talks on a new post-Brexit trade relationship still deadlocked.
Johnson said Saturday that a fast-moving new variant of the virus that is 70% more transmissible than existing strains appeared to be driving the rapid spread of new infections in London and southern England in recent weeks. But he stressed “there’s no evidence to suggest it is more lethal or causes more severe illness,” or that vaccines will be less effective against it.
On Sunday, British Health Secretary Matt Hancock added to the alarm when he said “the new variant is out of control.” The U.K. recorded 35,928 further confirmed cases, around double the number from a week ago.
The Netherlands banned flights from the U.K. for at least the rest of the year. Ireland issued a 48-hour flight ban. Italy said it would block flights from the U.K. until Jan.6, and an order signed Sunday prohibits entry into Italy by anyone who has been in the U.K. in the last 14 days.
The World Health Organization tweeted late Saturday that it was "in close contact with U.K. officials on the new #COVID19 virus variant" and promised to update governments and the public as more is learned.
The new strain was identified in southeastern England in September and has been spreading in the area ever since, a WHO official told the BBC on Sunday.
Viruses mutate regularly, and scientists have found thousands of different mutations among samples of the virus causing COVID-19. Many of these changes have no effect on how easily the virus spreads or how severe symptoms are.
British health authorities said that while the variant has been circulating since September, it wasn’t until the last week that officials felt they had enough evidence to declare that it has higher transmissibility than other circulating coronaviruses.
Patrick Vallance, the British government’s chief scientific adviser, said officials are concerned about the new variant because it contained 23 different changes, “an unusually large number of variants” affecting how the virus binds to and enters cells in the body.
Officials aren't certain whether it originated in the U.K., Vallance added. But by December, he said it was causing over 60% of infections in London.
The annual Berlin International Film Festival is being put off this year due to the coronavirus pandemic and split into two parts later in 2021, organizers said Friday.
The “Berlinale” had been scheduled for February in the German capital but cannot go ahead due to the likelihood that coronavirus restrictions on large gatherings will continue, organizers said, reports AP.
To give the film industry a venue to market their products in the first quarter, however, a virtual Berlinale will be held online in March. Then in June, organizers are scheduling a summer event with numerous film screenings for the public in theaters and the open air.
“The division makes it possible to maintain the two supporting pillars: film market and festival,” organizers said.
In October, Indonesian diplomats and Muslim clerics stepped off a plane in China. While the diplomats were there to finalize deals to ensure millions of doses reached Indonesian citizens, the clerics had a much different concern: Whether the COVID-19 vaccine was permissible for use under Islamic law.
As companies race to develop a COVID-19 vaccine and countries scramble to secure doses, questions about the use of pork products — banned by some religious groups — has raised concerns about the possibility of disrupted immunization campaigns, reports AP.
Pork-derived gelatin has been widely used as a stabilizer to ensure vaccines remain safe and effective during storage and transport. Some companies have worked for years to develop pork-free vaccines: Swiss pharmaceutical company Novartis has produced a pork-free meningitis vaccine, while Saudi- and Malaysia-based AJ Pharma is currently working on one of their own.
But demand, existing supply chains, cost and the shorter shelf life of vaccines not containing porcine gelatin means the ingredient is likely to continue to be used in a majority of vaccines for years, said Dr. Salman Waqar, general secretary of the British Islamic Medical Association.
Spokespeople for Pfizer, Moderna and AstraZeneca have said that pork products are not part of their COVID-19 vaccines. But limited supply and preexisting deals worth millions of dollars with other companies means that some countries with large Muslim populations, such as Indonesia, will receive vaccines that have not yet been certified to be gelatin-free.
This presents a dilemma for religious communities, including Orthodox Jews and Muslims, where the consumption of pork products is deemed religiously unclean, and how the ban is applied to medicine, he said.
“There’s a difference of opinion amongst Islamic scholars as to whether you take something like pork gelatin and make it undergo a rigorous chemical transformation,” Waqar said. “Is that still considered to be religiously impure for you to take?”
The majority consensus from past debates over pork gelatin use in vaccines is that it is permissible under Islamic law, as “greater harm” would occur if the vaccines weren’t used, said Dr. Harunor Rashid, an associate professor at the University of Sydney.
There’s a similar assessment by a broad consensus of religious leaders in the Orthodox Jewish community as well.
“According to the Jewish law, the prohibition on eating pork or using pork is only forbidden when it’s a natural way of eating it,” said Rabbi David Stav, chairman of Tzohar, a rabbinical organization in Israel.
If “it’s injected into the body, not (eaten) through the mouth,” then there is “no prohibition and no problem, especially when we are concerned about sicknesses,” he said.
Yet there have been dissenting opinions on the issue — some with serious health consequences for Indonesia, which has the world’s largest Muslim population, some 225 million.
In 2018, the Indonesian Ulema Council, the Muslim clerical body that issues certifications that a product is halal, or permissible under Islamic law, decreed that the measles and rubella vaccines were “haram,” or unlawful, because of the gelatin. Religious and community leaders began to urge parents to not allow their children to be vaccinated.
“Measles cases subsequently spiked, giving Indonesia the third-highest rate of measles in the world,” said Rachel Howard, director of the health care market research group Research Partnership.
A decree was later issued by the Muslim clerical body saying it was permissible to receive the vaccine, but cultural taboos still led to continued low vaccination rates, Howard said.
“Our studies have found that some Muslims in Indonesia feel uncomfortable with accepting vaccinations containing these ingredients,” even when the Muslim authority issues guidelines saying they are permitted, she said.
Governments have taken steps to address the issue. In Malaysia, where the halal status of vaccines has been identified as the biggest issue among Muslim parents, stricter laws have been enacted so that parents must vaccinate their children or face fines and jail time. In Pakistan, where there has been waning vaccine confidence for religious and political reasons, parents have been jailed for refusing to vaccinate their children against polio.
But with rising vaccine hesitancy and misinformation spreading around the globe, including in religious communities, Rashid said community engagement is “absolutely necessary.”
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“It could be disastrous,” if there is not strong community engagement from governments and health care workers, he said.
In Indonesia, the government has already said it will include the Muslim clerical body in the COVID-19 vaccine procurement and certification process.
“Public communication regarding the halal status, price, quality and distribution must be well-prepared,” Indonesian President Joko Widodo said in October.
While they were in China in the fall, the Indonesian clerics inspected China’s Sinovac Biotech facilities, and clinical trials involving some 1,620 volunteers are also underway in Indonesia for the company’s vaccine. The government has announced several COVID-19 vaccine procurement deals with the company totaling millions of doses.
Sinovac Biotech, as well as Chinese companies Sinopharm and CanSino Biologics — which all have COVID-19 vaccines in late-stage clinical trials and deals selling millions of doses around the world — did not respond to Associated Press requests for ingredient information.
In China, none of the COVID-19 vaccines has been granted final market approval, but more than 1 million health care workers and others who have been deemed at high risk of infection have received vaccines under emergency use permission. The companies have yet to disclose how effective the vaccines are or possible side effects.
Also read: Global Covid-19 cases cross 75.5 million
Pakistan is late-stage clinical trials of the CanSino Biologics vaccine. Bangladesh previously had an agreement with Sinovac Biotech to conduct clinical trials in the country, but the trials have been delayed due to a funding dispute. Both countries have some of the largest Muslim populations in the world.
While health care workers on the ground in Indonesia are still largely engaged in efforts to contain the virus as numbers continue to surge, Waqar said government efforts to reassure Indonesians will be key to a successful immunization campaign as COVID-19 vaccines are approved for use.
But, he said, companies producing the vaccines must also be part of such community outreach.
“The more they are transparent, the more they are open and honest about their product, the more likely it is that there are communities that have confidence in the product and will be able to have informed discussions about what it is they want to do,” he said.
“Because, ultimately, it is the choice of individuals.”
Aslo read: Covid-19 vaccine not a ‘silver bullet’: WHO
The coronavirus pandemic did not produce Elena Simone’s first budgetary rough patch. The 49-year-old single mother found herself out of the job market when the 2008 global financial crisis hit Italy and never fully got back in, but she created a patchwork of small jobs that provided for herself and the youngest of her three children.
That all changed with Italy’s first COVID-19 lockdown in the spring.
With schools closed, so went Simone’s cafeteria job. Her housecleaning gigs dried up, too. While others returned to work when the lockdown ended, Simone stayed frozen out.
“There was a period when I was only eating carrots,” she recalled from her kitchen decorated with colorful plush characters shaped like vegetables.
For the first time in her life, Simone needed help putting food on the table. At a friend’s urging, she enrolled for access to the food stores operated by Roman Catholic charity Caritas. Her eligibility covers her through January, and she hopes to be off the charity rolls by then “to make room for people who need it even more.”
The charity serving more than 5 million people in the Milan archdiocese, Caritas Ambrosiana, says the pandemic is revealing for the first time the depths of economic insecurity in Italy’s northern Lombardy region, which generates 20% of the country’s gross domestic product.
Simone, who has two adult children and a 10-year-old son at home, is typical of Italy’s new poor. These are people who managed to get by after the 2008 financial crisis, staying off the radar of Italy’s welfare system by relying on informal, gray-market jobs and the help of friends and family.
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But between Italy’s near-total spring lockdown, the introduction of a partial lockdown when the virus surged again in the fall and the continued toll the pandemic is taking on Italy’s economy, the slim threads that allowed people to weave together employment have snapped.
Nowhere in Italy is this more evident than in Lombardy, where COVID-19 first exploded in Europe. Italian agriculture lobby Coldiretti estimates that the virus has created 300,000 newly poor people, based on surveys of the dozens of charity groups operating in the region.
Caritas Ambrosiana provided help to 9,000 people during the spring lockdown, 20% of whom reported that their financial situation had “drastically” worsened over the 10-week closure. In October, nearly 700 families requested food aid for the first time.
Nationally, one-third of all people seeking help from Caritas during the pandemic are first-time recipients, and in a reversal of usual trends, most are Italians and not foreign residents.
More than 40 organizations provide food on a daily basis in Milan, Italy’s financial capital. One of the largest, Pane Quotidiano, serves some 3,500 meals a day. Many of those in need once worked in restaurants and hotels, which have been particularly penalized by the coronavirus restrictions, or as domestic help.
“It is even more widespread than we knew, especially for a rich city like Milan,” Caritas Ambrosiana spokesman Francesco Chiavarini said. “These precarious jobs were lost. And we don’t know when or if they will be restored.”
Researchers at Milan’s Bocconi University said in a working paper for the Organization for Economic Cooperation and Development that blue-collar workers without college degrees paid the heaviest price for Italy’s virus restrictions. Half reported a drop in their salaries, compared with just 20% of the top earners, and many did not have the luxury of working remotely.
“What we are seeing is a substantial increase in inequality,” Bocconi University researcher Vincenzo Galasso said.
Those without solid job contracts are the most exposed in the pandemic that has already killed over 68,000 people in Italy, the highest death toll in Europe.
Simone discovered too late that her cafeteria contract described her as an occasional worker, meaning she had no basis to request government support to replace lost income. Her cleaning jobs were off the books altogether, and she has recovered only two of the dozen she held before the pandemic.
Even when workers qualify for Italy’s public-private short-term layoff scheme, the money has arrived late and is generally inadequate to cover a family’s basic expenses, Chiavarini said. Basic coverage is 400 euros ($490) a month, yet monthly rents in a city like Milan start around 600 euros ($735).
Food security is emerging as a key issue as the pandemic enters winter.
Progetto Arca, which runs shelters and provides other social services in Milan, started operating a food truck last month after seeing that homeless people who had filled their stomachs with restaurant and bar handouts were going hungry during the partial fall lockdown when many establishments had closed.
And isn’t just the homeless coming by the food truck. On a recent night, a well-dressed man in a quilted jacket and dress trousers waited off to the side until the line had dissipated. He identified himself as a lawyer but declined further comment and asked not to be photographed as he took away two hot meals and two bags of food for the next day, one for his companion waiting at home.
So far, government moratoriums on evictions and the firing of contracted workers have helped keep a cap on what charity workers see as an emerging poverty crisis.
“When these are lifted, we will see the real price that we need to pay for this pandemic,” Chiavarini said. “We celebrate Milan as the capital of innovation, but beneath these skyscrapers of which we are so proud, there is a hidden world where people are living in conditions of real precariousness. “