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world news Diaranson 2 December 2020

EU eyes Dec 29 approval for 1st virus vaccine, later than US

(AP) — The European been preparing to start im- Food and Drug Administra-
Union drug agency said munizing people from mid- tion’s scientific advisers are
Tuesday it may need four December onward. holding a public meeting
more weeks to approve its Dec. 10 to review Pfizer’s re-
first coronavirus vaccine, On Tuesday, officials in Ger- quest to allow emergency use
even as authorities in the many, France and the Neth- of its vaccine, and a decision
United States and Brit- erlands cautioned that vac- could come shortly thereaf-
ain continue to aim for a cine programs likely won't ter.
green light before Christ- start until the end of the year.
mas. Stephen Evans, a professor
“With the information we at the London School of Hy-
The European Medicines got in recent days we have giene and Tropical Medicine,
Agency plans to convene a to assume that approval will said that although the main
meeting by Dec. 29 to decide only happen around the turn drug regulators will all ana-
if there is enough safety and of the year,” German Health lyze the same data, the Eu- has a drug regulatory agency around the world the shot, or
efficacy data about the vac- Minister Jens Spahn said. ropean regulator's decision- will have to issue its own ap- two if a booster is necessary,
cine developed by Pfizer and making process is slowed by proval for any COVID-19 meaning that people will be
BioNTech for it to be ap- “It has moved because some the bureaucracy of the 27-na- vaccine, although countries living with some virus con-
proved. The regulator also studies obviously need a little tion bloc. with weak systems usually trol measures at least well
said it could decide as early as longer to be submitted," he rely on the World Health Or- into next year.
Jan. 12 whether to approve a said. "What’s important is to He explained that approval ganization to vet the shots. In
rival shot by American phar- be prepared.” at the EMA “requires coop- the EU, countries typically While the three major vac-
maceutical company Mod- eration from member states, accept EMA approval for vac- cines so far submitted for ap-
erna Inc, which submitted its His comments were echoed who each have a say in the cines and drugs unless there proval seem to prevent peo-
request to U.S. and European by French President Em- authorization of a vaccine.” is a specific issue the country ple from getting sick, it is still
regulators this week. manuel Macron and Dutch wants examined further. unclear whether they prevent
Health Minister Hugo de British regulators also are as- people from picking up the
If its vaccine is approved, Jonge, who said authorities in sessing another vaccine de- Multiple successful vaccines virus entirely — and crucially
Germany-based BioNTech those countries are working veloped by researchers from will be needed to end the — passing it to others.
said the shot's use in Europe to begin vaccinating people Oxford University and drug- pandemic, which has been
could begin before the end of in the first week of January. maker AstraZeneca. on the upswing in Europe The EU's top official said
2020 — but that seems quite and the U.S. and so far left Tuesday around 2 billion dos-
ambitious, given that the EU “It won’t be a vaccination Whichever of the three regu- more than 1.4 million people es of potential COVID-19
Commission usually needs to policy for the broader public” lators — American, British worldwide dead. vaccines have been secured
rubber-stamp the regulator's during the first few months, or European — acts earliest for the bloc's 27 nations and
decision. Still, the agency has Macron said at a news con- would be giving the first ap- Authorities and drugmakers called hope for their quick
also left open the possibility ference. proval of a COVID-19 vac- have pledged to work togeth- approval "a huge step forward
that the date of that meeting cine that’s been that’s been er to immediately begin roll- toward our normal life."
will be brought forward if BioNTech and U.S. partner rigorously tested in tens of ing out the first shots once
data comes in faster. Pfizer have said that clinical thousands of people in trials approval comes in, whether EU Commission President
trials showed their vaccine is that meet common scientific that’s in the United States or Ursula von der Leyen, how-
Any approval granted by the 95% effective. The two com- standards. Europe. ever, urged EU citizens to re-
European regulator will be panies have already submit- main “disciplined till we have
conditional on companies ted data to regulators in the Numerous other vaccines are “Depending on how the reached finally a vaccination
submitting further informa- United States and Britain, also being worked on. Russia authorities decide we can that is appropriate to eradi-
tion to confirm the vaccine’s and approval might come and China have even begun start delivering within a few cate this virus.”
benefits outweigh the risks. from them first. administering shots of locally hours,” said BioNTech's
developed vaccines and sell- chief operating officer, Sierk Even after vaccines are ap-
The date now being eyed Hospitals in England have ing them to other countries Poetting. proved, manufacturers and
would be later than some Eu- been told they could receive but have not published evi- regulators will be monitoring
ropean countries had hoped. the first doses of the Pfizer dence from advanced studies But officials caution that how well they are received
Germany, which has given shot as early as the week of proving the vaccines are safe while some people may re- by patients to determine the
BioNTech 375 million eu- Dec. 7 if it receives the OK, and effective. ceive a vaccine in the coming frequency of rarer side effects
ros ($450 million) in funding the Guardian and Financial weeks, it will likely take years that may only appear when
to develop the vaccine, has Times reported. The U.S. Globally, every country that to give billions of people millions are immunized.

Canada: US border measures to last until virus under control

(AP) — Canadian Prime Minis- Broadcasting Corporation. vaccine-production facilities.
ter Justin Trudeau said Tuesday About 400,000 people crossed the
the ban on nonessential travel “We are incredibly lucky that trade world’s longest international border But Trudeau said at a news confer-
with the United States will not in essential goods, in agriculture each day before the pandemic. ence on Tuesday that Canada was
be lifted until COVID-19 is sig- products, in pharmaceuticals is among the first to pre-order Mod-
nificantly more under control flowing back and forth as it always About 75% of Canada’s exports go to erna's vaccine candidate and, “We
around the world. had,” he said. "It’s just people not the U.S. which has more confirmed are guaranteed some of Moderna’s
travelling, which I think is the im- cases and deaths from COVID-19 first batch if the vaccine is safe and
Canada and the U.S. have limited portant thing.” than any country in the world. approved.”
border crossings since March, ex-
tending the restrictions each month. Trudeau said although President- Trudeau has come under criticism "Already, Moderna has submitted
elect Joe Biden has an “obvious” from opposition parties for saying their candidate for Health Canada
“Until the virus is significantly different approach to the pandemic Canadians won’t be among the first review, as have Pfizer-BioNTech
under more control everywhere than President Donald Trump, the to get a vaccine against COVID-19 and AstraZeneca-Oxford. And just
around the world, we are not going situation in the U.S. remains seri- because the first doses will likely go yesterday, Johnson & Johnson joined
to be releasing the restrictions at the ous and it will take awhile to change to citizens of the countries they are this list as the fourth candidate for
border," Trudeau told the Canadian that. made in. Canada doesn't have mass Health Canada’s review."