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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 more than 1.34
million lives worldwide:
Who is furthest along?
U.S. drugmaker Pfizer Inc <PFE.N> and German partner BioNTech SE <BNTX.O>
<22UAy.DE> released final late-stage trial data on Wednesday that
showed their shot was 95% effective at stopping COVID-19, the
highest efficacy rate so far.
The companies are the first to publish final Phase III efficacy and
safety data and plan to apply for an emergency use authorization (EUA)
in the United States within days.
On Monday, another U.S. pharmaceutical company, Moderna Inc <MRNA.O>,
released interim data showing that its vaccine worked in a large,
late-stage clinical trial with a 94.5% efficacy rate.
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.
Pfizer's final results were based on 170 cases within its trial
involving more than 43,000 participants.
Moderna conducted its interim analysis after 95 participants
developed COVID-19 while Russia's examination was conducted after 20
volunteers developed the disease.
AstraZeneca said two weeks ago that a slowdown in infections during
the summer is delaying data analysis for its UK trial.
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How well are the vaccines supposed to work?
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?
Pfizer/BioNTech plan to submit an EUA application in the United States within
days. Moderna aims to file an application in the coming weeks once it has the
two months of safety data on half the trial participants, as required by the
U.S. Food and Drug Administration. That should happen in the second half of
November.
That means an FDA decision is unlikely before December.
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 Biotech
<SVA.O>.
Sinovac said on Wednesday mid-stage trial results showed its CoronaVac vaccine
triggered a quick immune response but the level of antibodies produced was lower
than in people who had recovered from the disease.
CNBG has said to expects 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,
Edwina Gibbs and David Clarke
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