Production and delivery challenges set up turbulent Year of the Vaccine

By John Miller
ZURICH (Reuters) - As of the end of 2020, regulatory approval of COVID-19 vaccines has raised hopes that the world can beat the pandemic in the next year. However, the challenges in production and delivery suggest that fighting the disease will be a marathon with a finish line still a long way off.
Europe followed Britain and the United States on Monday to give the green light to a COVID-19 vaccine from Pfizer and its partner BioNTech, which, like a similar shot from Moderna with US emergency approval, showed 95% effectiveness in large studies.
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The rapid approval of vaccines just a year after the new coronavirus was discovered in Wuhan, China, is testament to the tremendous global effort to fight a pandemic that killed more than 1.7 million people that hit the economy in Affected and life changed.
Scientists identified promising candidates in just a few weeks, not the years it would normally take, and millions of cans are already rolling out of the factories.
Progress is coming, however, as many countries weather a dreary winter of rising infections, a new, fast-spreading variant of the virus in the UK and countries around the world imposing new restrictions on travel and everyday life.
A third vaccine from AstraZeneca and Oxford University has also been shown to prevent COVID-19, although more work is needed on effectiveness issues to win over some regulators.
Still, the progress has been breathtaking.
"It is unprecedented that three potential vaccines have been developed in a short period of time, all of which show promise," said Marcel Tanner, President of the Swiss Academies of Arts and Sciences and member of the Swiss COVID-19 Science Task Force.
Vaccinations have started in the UK and United States, and shipments have also made to Canada, Israel and Mexico. EU countries have announced that recordings will start days after Christmas, while Switzerland and Qatar approved the Pfizer / BioNTech vaccine over the weekend.
Even so, BioNTech's chief executive Ugur Sahin predicted Tuesday that the "new normal" would keep society dealing with sporadic COVID-19 outbreaks for the next decade. Multiple vaccines would help prevent downtime and congested hospitals.
"This winter we will not have any influence on the number of infections, but we have to have an influence so that the next winter becomes the new normal case," said Sahin.
More than 100 other vaccine candidates are in the works. Further test data are expected shortly.
Vaccine experts say it takes multiple shots to provide enough doses to vaccinate the world from rich to poor.
The International Association of Pharmaceutical Manufacturers and Associations expects up to 10 vaccines to be approved by mid-2021, including the US companies Johnson & Johnson and Novavax and the German company CureVac.
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However, major challenges remain, including ramping up production.
Pfizer expects only 50 million shots in 2020, half of its original target, and covers 25 million people with its two-dose regimen. Moderna has pledged 20 million U.S. vaccinations this year, covering 10 million people.
Production is set to accelerate in 2021, with combined production potentially exceeding 1.8 billion cans.
Developments from other companies are similar, but shipments won't come fast enough for a world hungry for vaccines.
"There just won't be enough vaccines to last a long time ... maybe well into 2022," said Tom Frieden, former director of the US Centers for Disease Control and Prevention (CDC).
There were also early issues related to the storage and dispensing of the Pfizer / BioNTech vaccine, which must be kept in Antarctic temperatures, as well as confusion about how many doses are actually in a vial.
Some healthcare workers in the UK and US have also had allergic reactions.
And although studies of tens of thousands have shown that the new mRNA technology used by Pfizer / BioNTech and Moderna appears safe, there is still great concern among people about actually getting gunshots when their number is called.
The World Health Organization (WHO) estimates that around 60% of people need to be vaccinated to achieve herd immunity, which means enough people are protected to keep the disease from spreading.
Developing countries hoping to gain access to vaccines through a WHO-supported global program may have to wait as wealthier countries reserve starting stocks.
So far, the West has mainly focused on vaccinating frontline medical professionals and elderly nursing home residents, with even limited amounts of vaccines could make a difference for the populations hardest hit by the virus.
Eighty percent of the more than 300,000 US COVID-19 deaths were people over 65, according to the CDC.
"This could solve the COVID-19 health crisis, even if herd immunity is not achieved due to vaccination skepticism," said Christian Muenz, Professor of Viral Immunobiology at the University of Zurich.
HITS, MISSES
So far, Russia has vaccinated more than 200,000 people with its homemade Sputnik-V shot, which developers say is 91.4% effective. The country has also signed manufacturing agreements, including with India.
In China, where a Sinovac Biotech candidate and two from the China National Pharmaceutical Group (Sinopharm) are in late-stage trials, health workers and border officials have fired shots to boost production.
Sinopharm's vaccine is registered in Bahrain and the United Arab Emirates, with Egypt also receiving supplies, while Sinovac has contracts to supply from Brazil, Turkey and Indonesia.
Other Chinese vaccines, including those from CanSino Biologics, are also in late-stage studies.
However, not all vaccine projects have achieved the goal.
Sanofi and GlaxoSmithKline delayed their candidate after failing to protect the elderly.
An Australian project also flopped.
And there are still questions about AstraZeneca's vaccine, which was 62% effective in patients who received two full doses.
Eric Topol, founder of California's Scripps Research Translational Institute, said the vaccines against Pfizer / BioNTech and Moderna were difficult to follow.
"We can't accept 62% if you can get 95%," Topol said. "It would have been good enough if we hadn't had anything else."

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