[新聞] 輝瑞表示三劑疫苗能有效保護五歲以下兒童
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1.媒體來源: AP News
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2.記者署名:LAURAN NEERGAARD
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3.完整新聞標題:Pfizer says 3 COVID shots protect children under 5
※ 標題沒有完整寫出來 ---> 依照板規刪除文章
4.完整新聞內文:
Three doses of Pfizer’s COVID-19 vaccine offer strong protection for
children younger than 5, the company announced Monday. Pfizer plans to give
the data to U.S. regulators later this week in a step toward letting the
littlest kids get the shots.
輝瑞公司於週一宣布 三劑COVID-19疫苗能有效保護五歲以下的兒童 並計畫於本週
提交資料給美國監管機構
The news comes after months of anxious waiting by parents desperate to
vaccinate their babies, toddlers and preschoolers, especially as COVID-19
cases once again are rising. The 18 million tots under 5 are the only group
in the U.S. not yet eligible for COVID-19 vaccination.
The Food and Drug Administration has begun evaluating data from rival
Moderna, which hopes to begin offering two kid-sized shots by summer.
Pfizer has had a bumpier time figuring out its approach. It aims to give tots
an even lower dose — just one-tenth of the amount adults receive — but
discovered during its trial that two shots didn’t seem quite strong enough
for preschoolers. So researchers gave a third shot to more than 1,600
youngsters — from age 6 months to 4 years — during the winter surge of the
omicron variant.
In a press release, Pfizer and its partner BioNTech said the extra shot did
the trick, revving up tots’ levels of virus-fighting antibodies enough to
meet FDA criteria for emergency use of the vaccine with no safety problems.
Preliminary data suggested the three-dose series is 80% effective in
preventing symptomatic COVID-19, the companies said, but they cautioned the
calculation is based on just 10 cases diagnosed among study participants by
the end of April. The study rules state that at least 21 cases are needed to
formally determine effectiveness, and Pfizer promised an update as soon as
more data is available.
The companies already had submitted data on the first two doses to the FDA,
and BioNTech’s CEO, Dr. Ugur Sahin, said the final third-shot data would be
submitted this week.
“The study suggests that a low, 3-microgram dose of our vaccine, carefully
selected based on tolerability data, provides young children with a high
level of protection against the recent COVID-19 strains,” he said in a
statement.
What’s next? FDA vaccine chief Dr. Peter Marks has pledged the agency will “
move quickly without sacrificing our standards” in evaluating tot-sized
doses from both Pfizer and Moderna.
The agency has set tentative dates next month for its scientific advisers to
publicly debate data from each company.
Moderna is seeking to be the first to vaccinate the littlest kids. It
submitted data to the FDA saying tots develop high levels of virus-fighting
antibodies after two shots that contain a quarter of the dose given to
adults. The Moderna study found effectiveness against symptomatic COVID-19
was 40% to 50% during the omicon surge, much like for adults who’ve only had
two vaccine doses.
Complicating Moderna’s progress, the FDA so far has allowed its vaccine to
be used only in adults.
The FDA is expected to review Moderna’s data on both the youngest age group,
plus its study of teens and elementary-age children. Other countries already
have expanded Moderna’s shot to kids as young as 6.
While COVID-19 generally isn’t as dangerous to youngsters as to adults, some
children do become severely ill or even die. And the omicron variant hit
children especially hard, with those under 5 hospitalized at higher rates
than at the peak of the previous delta surge.
雖然COVID-19對青少年的危險性一般不比成人高 但有些兒童確實會得重病 甚至死亡
omicron變異對兒童的打擊特別大 5歲以下兒童的住院率比之前delta激增的高峰期還
要高
It’s not clear how much demand there will be to vaccinate the youngest kids.
Pfizer shots for 5- to 11-year-olds opened in November, but only about 30% of
that age group have gotten the recommended initial two doses. Last week, U.S.
health authorities said elementary-age children should get a booster shot
just like everyone 12 and older is supposed to get, for the best protection
against the latest coronavirus variants.
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