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Pfizer Says Early Data Signals COVID-19 Vaccine Is Effective
2020-11-09 12:47:19.2 GMT

By LINDA A. JOHNSON and LAURAN NEERGAARD
(AP) — Pfizer says an early peek at its vaccine data
suggests the shots may be 90% effective at preventing COVID-19,
indicating the company is on track later this month to file an
emergency use application with U.S. regulators.
Monday's announcement doesn't mean a vaccine is imminent:
This interim analysis, from an independent data monitoring
board, looked at 94 infections recorded so far in a study that
has enrolled nearly 44,000 people in the U.S. and five other
countries.
Pfizer Inc. did not provide any more details about those
cases, and cautioned the initial protection rate might change by
the time the study ends. Even revealing such early data is
highly unusual.
“We’re in a position potentially to be able to offer some
hope,” Dr. Bill Gruber, Pfizer’s senior vice president of
clinical development, told The Associated Press. “We’re very
encouraged.”
Authorities have stressed it's unlikely any vaccine will
arrive much before the end of the year, and limited initial
supplies will be rationed.
“We need to see the data, but this is extremely promising,”
said Dr. Jesse Goodman of Georgetown University.
He ticked off many questions still to be answered including
how long the vaccine's effects last and if it also protects
older people as well as younger people.
If Pfizer's vaccine ultimately pans out, "it’s going to be
a while before this has a major impact at the population level,”
said Goodman, a former chief of Food and Drug Administration’s
vaccine division.
The interim results were “an interesting first signal,” but
questions remain, said Marylyn Addo, head of the tropical
medicine unit at UKE hospital in Hamburg, Germany.
Global markets, already buoyed by the victory of U.S.
President-elect Joe Biden, exploded on the news from Pfizer. All
major markets in Europe, where infections have soared, are up
5%. In the U.S., Dow futures also rose 5% and were up about
1,400 points just over two hours before the opening bell.
The shots made by Pfizer and its German partner BioNTech
are among 10 possible vaccine candidates in late-stage testing
around the world — four of them so far in huge studies in the
U.S. Another U.S. company, Moderna Inc., also has said it hopes
to be able to file an application with the FDA later this month.
Volunteers in the final-stage studies, and the researchers,
don't know who received the real vaccine or a dummy shot. But a
week after their second required dose, Pfizer's study began
counting the number who developed COVID-19 symptoms and were
confirmed to have the coronavirus.
Because the study hasn't ended, Gruber couldn't say how
many in each group had infections. Doing the math, that would
mean almost all the infections counted so far had to have
occurred in people who got the dummy shots.
Pfizer doesn’t plan to stop its study until it records 164
infections among all the volunteers, a number that the FDA has
agreed is enough to tell how well the vaccine is working. The
agency has made clear that any vaccine must be at least 50%
effective.
No participant so far has become severely ill, Gruber said.
Nor could he provide a breakdown of how many of the infections
had occurred in older people, who are at highest risk from
COVID-19.
Participants were tested only if they developed symptoms,
leaving unanswered whether vaccinated people could get infected
but show no symptoms and unknowingly spread the virus.
FDA has required that U.S. vaccine candidates be studied in
at least 30,000 people. In addition to adequate numbers of older
adults, those studies must also include other groups at high
risk, including minorities and people with chronic health
problems.
And it told companies they must track half their
participants for side effects for at least two months, the time
period when problems typically crop up. Pfizer expects to reach
that milestone later this month, but said Monday no serious
safety concerns have been reported.
Because the pandemic is still raging, manufacturers hope to
seek permission from governments around the world for emergency
use of their vaccines while additional testing continues —
allowing them to get to market faster than normal but raising
concerns about how much scientists will know about the shots.
The FDA's scientific advisers last month said they worry
that allowing emergency use of a COVID-19 vaccine could damage
confidence in the shots and make it harder to ever find out how
well they really work. Those advisers said it's critical these
massive studies are allowed to run to completion.
___
AP writers Frank Jordans and Charles Sheehan contributed to
this report.
___
The Associated Press Health and Science Department receives
support from the Howard Hughes Medical Institute’s Department of
Science Education. The AP is solely responsible for all content.

-0- Nov/09/2020 12:47 GMT

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