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U.S. NEWS Friday 11 december 2020
U.S. panel endorses widespread use of Pfizer COVID-19 vaccine

By LAURAN NEERGAARD urged Pfizer to take addi-
and MATTHEW PERRONE tional steps to answer that
Associated Press question.
WASHINGTON (AP) — A U.S. Several of the dissenting
government advisory panel panel members objected
endorsed widespread use to authorizing the shot for
of Pfizer’s coronavirus vac- 16- and 17-year-olds, given
cine Thursday, putting the their small numbers in the
country just one step away study and the low risk they
from launching an epic face from COVID-19.
vaccination campaign Members worried, too, that
against the outbreak that Pfizer will lose its opportu-
has killed close to 300,000 nity to answer critical ques-
Americans. tions once it begins offering
Shots could begin within the real vaccine to study
days, depending on how participants who had been
quickly the Food and Drug getting dummy shots up to
Administration signs off, as now.
expected, on the expert The company proposed
committee’s recommen- gradually moving those pa-
dation. tients to the vaccine group,
“This is a light at the end of with priority based on age,
the long tunnel of this pan- Documents created by Pfizer for the meeting with the Food and Drug Administration advisory health conditions and oth-
demic,” said Dr. Sally Goza, panel, as Pfizer seeks approval for emergency use of their COVID-19 vaccine, are seen on Thurs- er factors. Under that plan,
president of the American day, Dec. 10, 2020. 70-year-old participants
Academy of Pediatrics. Associated Press would cross over before
In a 17-4 vote with one ab- healthy 30-year-olds.
stention, the government until ramped-up produc- expert meeting that a de- after FDA scientists issued a Pfizer must still show wheth-
advisers concluded that tion enables shots to be- cision would come within glowing review of the vac- er the vaccine works in chil-
the vaccine from Pfizer and come widely available on “days to a week.” cine earlier in the week. dren younger than 16 and
its German partner BioN- demand — something that The independent review by Agency staffers said data in pregnant women.
Tech appears safe and ef- will probably not happen non-government experts from Pfizer’s ongoing study On the safety front, as
fective for emergency use until the spring. in vaccine development, of 44,000 people showed widespread vaccinations
in adults and teenagers 16 Next week, the FDA will re- infectious diseases and strong protection across begin, the first recipients
and over. view a second vaccine, medical statistics was con- different age groups, rac- will be closely tracked by
That endorsement came from Moderna and the Na- sidered critical to boosting es and health conditions government health author-
despite questions about tional Institutes of Health, Americans’ confidence with no major, unexpected ities since studies in tens of
allergic reactions in two that appears about as pro- in the safety of the shot, safety problems. thousands of people can’t
people who received the tective as Pfizer-BioNTech’s which was developed at The Pfizer-BioNTech shot detect rare risks that strike
vaccine earlier this week shot. A third candidate, breakneck speed less than remains experimental be- 1 in a million. Hanging over
when Britain became the from Johnson & Johnson, a year after the virus was cause that final-stage study the meeting were the Brit-
first country to begin dis- which would require just identified. isn’t complete. As a result, ish allergic reactions and
pensing the Pfizer-BioNTech one dose, is working its way Regulators not only in Brit- the expert panel wrestled a warning from authorities
shot. through the pipeline. Be- ain but in Canada have with a list of questions that there that people with a
While there are a number hind that is a candidate already approved the vac- have yet to be answered. history of serious reactions
of remaining unknowns from AstraZeneca and Ox- cine for use in their coun- For example, while the shouldn’t get the vaccine
about the vaccine, in an ford University. tries, and President Donald vaccine is more than 90% for now.
emergency, “the ques- U.S. health experts are hop- Trump and White House of- effective in blocking the Pfizer representatives said
tion is whether you know ing a combination of vac- ficials have complained for symptoms of COVID-19, the they have seen no signs of
enough” to press ahead, cines will ultimately enable weeks about the pace of FDA’s advisers stressed it is allergic reactions in their
said panel member Dr. Paul the U.S. to conquer the out- FDA’s careful review. not yet clear whether it can trial. But some of the FDA
Offit of Children’s Hospital break. “Americans want us to do a stop the silent, symptomless advisers fear the British
of Philadelphia. He con- But experts estimate at least scientific review, but I think spread that accounts for warning will deter millions
cluded that the potential 70% of the U.S. population they also want us to make up to half of all cases. of Americans with allergies
benefits outweigh the risks. will have to be vaccinated sure we’re not wasting time “Even though the individu- who might benefit from the
The decision came as CO- to achieve herd immunity, on paperwork as opposed al efficacy of this vaccine COVID-19 vaccine from
VID-19 cases surge to ev- the point at which the virus to going forward with the is very, very, very high, you giving it a try, and urged
er-higher levels across the can be held in check. That decision,” FDA Commis- really as of right now do not additional studies to try to
U.S., with deaths setting means it could be several sioner Stephen Hahn said have any evidence” that it settle the issue.
an all-time, one-day re- months before things start before the meeting. will lower transmission, said “This issue is not going to die
cord of more than 3,100 on get back to normal and A positive vote for the vac- Dr. Patrick Moore of the until we have better data,”
Wednesday. Americans can put away cine was virtually assured University of Pittsburgh. He Offit said.q
Pfizer has said it will have their masks.
about 25 million doses All eyes now turn to the
of the two-shot vaccine FDA staff scientists who
for the U.S. by the end of will make the final deci-
December. But the initial sion of whether to press
supplies will be reserved ahead with large-scale im-
primarily for health care munizations with the Pfizer-
workers and nursing home BioNTech vaccine. FDA’s
residents, with other vul- vaccine director Dr. Peter
nerable groups next in line Marks said ahead of the