Last checked at 
* Pfizer, Moderna to make at least 1.8 bln shots combined in
2021
* IFPMA sees up to 10 vaccines approved by mid-2021
* Production may lag demand well into 2022
By John Miller
ZURICH, Dec 23 (Reuters) - As 2020 closes, regulatory
approval of COVID-19 vaccines has raised hopes the world can
defeat the pandemic next year. But production and delivery
challenges suggest beating the disease will be a marathon whose
finish line is still far away.
Europe on Monday followed Britain and the United States in
giving a green light to a COVID-19 vaccine from Pfizer
and its partner BioNTech which, like a similar shot
from Moderna that has U.S. emergency approval,
demonstrated 95% efficacy in large trials.
The rapid approval of vaccines, just a year after the new
coronavirus was detected in Wuhan, China, is testament to the
huge global effort made to tackle a pandemic that has killed
over 1.7 million people, battered economies and upended life.
Scientists identified promising candidates after just weeks,
not the years normally needed, and millions of doses are already
rolling out of factories.
The progress comes, however, as many countries endure a
bleak winter, with infections surging, a new fast-spreading
variant of the virus in Britain and countries worldwide imposing
new restrictions on travel and everyday life.
A third vaccine from AstraZeneca and Oxford
University has also been shown to prevent COVID-19, though
questions over the level of its efficacy have left them with
more work to do to win over some regulators.
Still, the progress has been breathtaking.
"It's unprecedented that you have three potential vaccines
developed in a short period that are all promising," said Marcel
Tanner, president of the Swiss Academies of Arts and Sciences
and a Swiss COVID-19 Science Task Force member.
Inoculations have begun in Britain and the United States,
with shipments also going to Canada, Israel and Mexico. EU
countries have said shots will start days after Christmas, while
Switzerland and Qatar authorised Pfizer/BioNTech's vaccine at
the weekend.
Even so, BioNTech Chief Executive Ugur Sahin predicted on
Tuesday the "new normal" would see society dealing with sporadic
COVID-19 outbreaks for the next decade, with multiple vaccines
helping to avoid business shutdowns and overloaded hospitals.
"This winter we will not have an impact on the infection
numbers, but we must have an impact so that the next winter will
be the new normal," Sahin said.
More than 100 other vaccine candidates are in the works,
with trial data on several expected soon.
Vaccine experts say multiple shots will be needed to provide
enough doses to inoculate the world, from rich to poor.
The International Federation of Pharmaceutical Manufacturers
and Associations expects up to 10 vaccines to have won approval
by mid-2021, including from U.S. companies Johnson & Johnson
and Novavax and Germany's CureVac.
LIMITED SUPPLIES
Yet huge challenges remain, including ramping up production.
Pfizer expects to produce just 50 million shots for 2020,
half its original goal, covering 25 million people with its
two-dose regimen. Moderna has pledged 20 million U.S.
inoculations this year, covering 10 million people.
Manufacturing will accelerate in 2021, with combined
production potentially topping 1.8 billion doses.
Other companies' trajectories are similar, but supplies
won't come fast enough for a world hungry for vaccines.
"There just aren't going to be enough vaccines to go around
for a long time ... maybe well into 2022," said Tom Frieden,
former director of the U.S. Centers for Disease Control and
Prevention (CDC).
There have also been early hiccups related to storing and
delivering Pfizer/BioNTech's vaccine that must be kept at
Antarctic temperatures, as well as confusion over how many doses
are actually in a vial.
Allergic reactions in some UK and U.S. health care workers
have also emerged.
And though trials involving tens of thousands have shown the
new mRNA technology used by Pfizer/BioNTech and Moderna appears
safe, there is still plenty of hesitancy among people over
actually getting shots when their number is called.
The World Health Organization (WHO) estimates about 60% of
people need to get vaccinated to achieve herd immunity, meaning
enough people are protected for the disease to stop spreading.
Developing countries hoping to access vaccines via a global
WHO-backed scheme may have to wait, as wealthier countries have
reserved initial stocks.
So far, the West is focused largely on inoculating
front-line medical workers and older nursing home residents,
where even in limited volumes vaccines could make a difference
for populations hardest hit by the virus.
Eighty percent of the 300,000-plus U.S. COVID-19 deaths have
been people over 65, the CDC has said.
"This might take care of the COVID-19 healthcare crisis even
if, due to vaccine scepticism, no herd immunity is reached,"
said Christian Muenz, University of Zurich professor of viral
immunobiology.
HITS, MISSES
So far, Russia has inoculated 200,000-plus people with its
home-grown Sputnik-V shot, whose developers say it is 91.4%
effective. The country has also signed production deals,
including with India.
In China, where one Sinovac Biotech candidate and
two from China National Pharmaceutical Group (Sinopharm) are in
late-stage trials, health workers and border official have
gotten shots, amid spending to boost production.
Sinopharm's vaccine is registered in Bahrain and the United
Arab Emirates, with Egypt also getting deliveries, while Sinovac
has deals to supply Brazil, Turkey and Indonesia.
Other Chinese vaccines, including from CanSino Biologics,
are also in late-stage trials.
However, not all vaccine projects hit the bullseye.
Sanofi and GlaxoSmithKline delayed their
candidate after it failed to protect older people.
An Australian project also flopped.
And questions still surround AstraZeneca's vaccine, whose
efficacy was 62% among patients who received two full doses.
Eric Topol, founder of California-based Scripps Research
Translational Institute, said the Pfizer/BioNTech and Moderna
vaccines would be tough acts to follow.
"We can't accept 62% when you can get 95%," Topol said. "It
would have been good enough if we didn't have anything else."
