BERLIN: One of the developers of Russia's Sputnik V coronavirus vaccine announced that India-based drugmaker Hetero would produce over 100 million doses of the jab. Russia was the first country to approve a coronavirus vaccine in August, long before the candidate had undergone large-scale clinical trials.
Moscow said this week that interim results showed Sputnik V — named after the pioneering Soviet satellite — was 95 percent effective, although crucial Phase III trials are still underway. The Russian military said President Vladimir Putin has ordered the mass inoculation of 400,000 servicemen.
CDC emergency meeting for Tuesday
A committee that advises the US Centers for Disease Control and Prevention about vaccines has scheduled an emergency meeting for Tuesday, US media reported early on Saturday. The Advisory Committee on Immunization Practices (ACIP) posted the meeting announcement on its website with little explanation. While it does not say explicitly that the meeting is to discuss coronavirus vaccine distribution, there’s no other likely reason for such a meeting to be called.
A CDC spokesperson later confirmed the meeting was called to discuss coronavirus vaccines but could not provide more details. ACIP met on Monday to discuss whether to recommend any coronavirus vaccine that might get emergency use authorization (EUA) from the US Food and Drug Administration and to talk about who should be first in line to get one. While the FDA approves a vaccine, it’s the CDC, based on ACIP’s advice, that decides who should get vaccines and when. ACIP usually meets regularly three times a year but the approval of a pandemic vaccine is an unusual circumstance.
The CDC did not immediately answer requests for explanation about the meeting. So far, Pfizer is the only company to apply for an EUA from the FDA. The submission to the FDA was based on results from the Phase 3 clinical trial of Pfizer's vaccine, which began in the United States on July 27 and enrolled more than 43,000 volunteers.
EU agrees vaccine deal with Moderna
The European Union has reached a deal with US pharmaceutical firm Moderna to secure doses of its coronavirus vaccine candidate, European Commission chief Ursula von der Leyen announced on Tuesday. Last week, Moderna said its experimental vaccine was 94.5% effective in preventing the virus that has killed almost 1.5 million people and devastated the global economy.
In August, the EU's executive branch said early discussions with Moderna had been concluded with the aim of signing a contract for the supply of 80 million doses, with the option of acquiring a further 80 million at a later stage. It is the sixth deal of its kind the EU has negotiated with vaccine developers.
Data on 151 Moderna volunteers awaited
That final look at Moderna's data is expected within days after 151 volunteers in the 30,000-person study develop symptoms of the virus. It would be the final step before the biotech company files for an emergency use authorisation. Moderna is poised to be the second company to do so in the US after Pfizer filed with US regulators on Friday. Pfizer and German partner BioNTech SE's shot will face a Food and Drug Administration panel on December 10. This second interim analysis shows a high degree of effectiveness and shows it prevents illness in a way that's as good as the initial readout, things will start moving fast, said analysts.
EU approval if BioNTech, Moderna vaccines seen in December
BioNTech SE and Moderna Inc. could receive conditional European Union marketing authorisation for their Covid-19 vaccines in the second half of next month, according to the head of the EU's executive arm, putting the bloc on track to start distributing the shots at the same time as the US. The European Medicines Agency is in daily contact with the US Food and Drug Administration about the evaluation of the vaccines in order to "synchronize" assessment, said European Commission President Ursula von der Leyen.
"If all proceeds with no problems, EMA tells us that the conditional marketing authorisation for BioNTech and Moderna could happen as early as the second half of December 2020," von der Leyen told reporters after EU leaders discussed the Covid-19 pandemic via video conference on Thursday.
The speedy regulatory assessment comes as many European countries battle fierce new waves with the onset of colder weather, forcing governments to impose new lockdowns over weary populations. Faced with the prospects of another recession and uncertainty over how long the crisis may last, European leaders are increasingly counting on vaccines to provide relief.
This week, Moderna said its Covid-19 vaccine was 94.5% effective in a preliminary analysis of a large late-stage clinical trial. Pfizer Inc. said its shot being developed with BioNTech was 95% effective in a final analysis of clinical-trial data and it's applying to the U.S. FDA for emergency-use authorization.
Canada immunisation
In Canada, Prime Minister Justin Trudeau announced that a general who led NATO's mission in Iraq as well as Canadian troops in Afghanistan and Bosnia would spearhead a gigantic vaccination drive. "This will be the biggest immunisation in the history of the country," Trudeau said. Last week, Trudeau said the country needs "a very sophisticated" rollout plan that will require "high degrees of logistical support."
But determining which Canadians should get a vaccine first is extremely challenging without more details. "The rollout is going to be the most difficult part of this vaccine and that's the part I think everyone is starting to think of today," Dr. Zain Chagla, an infectious diseases specialist at St Joseph's Healthcare in Hamilton, told CBC's The National.
"If the vaccine data shows that the highest risk populations also have the highest reasonable benefit here, I think that prioritisation scheme works very well and hopefully that's the target for the first 10 million doses."
1 million cases in Germany
Germany, once a beacon of hope in Europe's coronavirus nightmare, logged more than one million cases on Friday, while Russia asked India to help mass produce its controversial Sputnik vaccine.
Although the virus spread is slowing thanks to weeks of tough restrictions, Europe remains at the heart of the pandemic, recording more cases than the United States in the past week. The pandemic is spreading fastest in Asia and Latin America, and is up by a worrying 113 percent over the week in Mexico.
Until recently, Germany's relative success in containing the virus had offered some sense of hope, with authorities putting in place some precautions that still allowed life to carry on almost as normal.However, its measured approach has failed during the second wave, endangering the health of Europe's biggest economy and weighing on the mood as the northern hemisphere heads into the winter holidays.
Germany's Robert Koch Institute recorded more than 22,000 new daily cases on Friday, pushing the overall total beyond the one-million mark. More worryingly, the number of Covid-19 patients in intensive care has soared from around 360 in early October to more than 3,500 last week.
Gradual reopening
Most countries hope to ease their virus rules for Christmas and New Year, allowing families a respite before bracing for what the world hopes is one last wave of restrictions until a clutch of promising new vaccines kick in. Belgium is to allow shops to reopen from December 1, but keep the current semi-lockdown in place possibly until mid-January. So far, the country of 11.5 million has only allowed retailers of essential goods, such as food, to do business.But the move mirrors similar easing in Germany, Luxembourg and the Netherlands. France, too, is scheduled to allow non-essential retailers to lift their shutters from Saturday.
The Italian government partially lifted restrictions in Lombardy and Piedmont in the north, and Calabria in the south, hanging their alert levels from red to orange. And Ireland has also announced a staggered easing of restrictions to allow some businesses to reopen and for families to gather ahead of Christmas.
Lockdown fatigue
Globally, more than 1.4 million deaths and 61 million infections have been officially recorded, although the real numbers are unknown since testing and reporting methods vary greatly. With the virus on the march and the rollout of the first vaccines not expected until next month, much of the world faces a gloomy winter under more lockdowns, with an accompanying increase in economic anxiety and mental strain. Bulgaria allowed its stores to enjoy one last spurt of business on Black Friday — usually the day shops are packed with people looking for holiday deals — before closing almost everything for three weeks shortly before midnight.
"People have only just started returning in the past three days and now we'll be shutting down for three weeks," one Sofia restaurant owner lamented. The mood was just as sour in the West Bank, where police in face masks set up road blocks on the first day of new restrictions that included weekend curfews.
Lockdown fatigue is spreading even as governments unfurl new measures to save healthcare systems from collapse, with Cyprus announcing a nightly curfew. Alcohol vendors organised a protest after Turkey — hitting one-day records of 177 deaths and nearly 30,000 infections on Friday — ordered them to close two hours earlier than other shops to help minimise socialising.
Spanish king tests negative
Nations are now trying to gauge how people, exhausted by one of the most traumatic years in generations, can enjoy a small holiday break without making things worse. France took the unusual step of allowing its winter sports resorts to stay open, but ordered ski-lifts to stay shut. Playing it safe, German Chancellor Angela Merkel has called for all EU resorts to be closed until January 10, making Switzerland - which is outside the bloc and is staying open - the go-to destination for ski fans.
In one piece of good news, Spain's King Felipe VI, in quarantine since Monday after having been in contact with an infected person, tested negative for Covid-19, but will continue to self-isolate for the time being, the palace said.
