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 The following is what we know about the race to deliver vaccines to
help end the coronavirus pandemic that has claimed over 1.26 million
lives worldwide:
Who is furthest along?
Moderna Inc <MRNA.O> is the second U.S. pharmaceutical company to
release interim data showing that its vaccine worked in a large,
late-stage clinical trial. The biotech firm said its vaccine was
94.5% effective.
One week ago, U.S. drugmaker Pfizer Inc <PFE.N> and German partner
BioNTech SE <BNTX.O> <22UAy.DE> released interim data and said their
shot was more than 90% effective at stopping COVID-19.
Interim late-stage trial results for Russia's Sputnik V vaccine
published on Nov. 11 showed the shot is 92% effective.
The next data release will likely be from AstraZeneca Plc <AZN.L>
with the University of Oxford in November or December. Johnson &
Johnson <JNJ.N> says it is on track to deliver data this year.
What happens in these trials?
The companies are testing their vaccines against a placebo -
typically saline solution - in healthy volunteers to see if the rate
of COVID-19 infection among those who got the vaccine is
significantly lower than in those who received the dummy shot.
What were pharma companies waiting for to release data?
The trials rely on subjects becoming naturally infected with the
coronavirus, so how long it takes to generate results largely
depends on how pervasive the virus is where trials are being
conducted. Each drugmaker has targeted a specific number of
infections to trigger a first analysis of their data.
Early in the trials, infection rates were low. With a surge in
infections around the globe in October and November, trial
participants became infected more quickly.
Moderna conducted its interim analysis after 95 participants
developed COVID-19. Pfizer's was done after 94 developed COVID-19
while Russia's examination was conducted after 20 developed the
disease.
AstraZeneca said two weeks ago that a slowdown in infections during
the summer is delaying data analysis for its UK trial.
How well are the vaccines supposed to work?
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The World Health Organization ideally wants to see at least 70% efficacy in
trials. The U.S. Food and Drug Administration wants at least 50% - which means
there must be at least twice as many infections among volunteers who received a
placebo as among those in the vaccine group. The European Medicines Agency has
said it may accept a lower efficacy level.
When will regulators rule on safety and efficacy?
Moderna and Pfizer/BioNTech plan to submit applications seeking U.S. emergency
use authorization (EUA) in the coming weeks after they have enough safety data,
which they have said would be in the second half of November.
That means the earliest the U.S. Food and Drug Administration could make a
decision is December. The FDA has asked companies to watch trial participants
for side effects for two months after receiving a final vaccine dose.
Regulators for Europe, the United Kingdom and Canada are considering data as it
becomes available. It is not clear when companies will submit efficacy data or
when the agencies would make a decision.
Could these be the first widely available coronavirus vaccines?
Yes, although China launched an emergency use program in July aimed at essential
workers and others at high risk of infection that has vaccinated hundreds of
thousands of people.
At least four Chinese vaccines are far along including those from China National
Biotec Group [CHNAPF.UL] (CNBG), CanSino Biologics <6185.HK> and Sinovac.
Sinovac and CNBG have said to expect early trial data as soon as November.
Russia has also given the Sputnik V vaccine developed by the Gamaleya Institute
to 10,000 members of the general population considered at high risk of
contracting the virus.
(Reporting by Carl O'Donnell in New York; Additional reporting by Julie
Steenhuysen in Chicago, Michael Erman in New York, Ludwig Burger in Frankfurt,
Alistair Smout in London and Polina Ivanova in Moscow; Editing by Caroline Humer
and Edwina Gibbs)
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