Regulators also plan to allow both adolescents and
adults to seek an extra shot of Pfizer’s vaccine five months after receiving a
second dose, instead of the current period of six months. A booster shot is
also expected to be authorised for younger children, ages 5 to 11, with immune
deficiencies.
The Centers for Disease Control and Prevention’s
vaccine advisory committee is planning to meet by the middle of next week to
vote on whether to recommend the changes. If the committee agrees with the
FDA’s authorisations, Dr Rochelle Walensky, the CDC director, is expected to
promptly endorse the revisions.
The move to expand boosters comes as the highly
contagious omicron variant is infecting a record number of Americans with the
coronavirus, putting more pressure on hospitals already deluged by COVID-19
patients from the delta variant.
More than 70% of people in the United States 12 years
and older are fully vaccinated, according to the CDC. Children can better
withstand coronavirus infections but in rare instances still can get very sick
and even die. At least 1.8 million adolescents between 12 and 15 years old have
tested positive for the virus, according to the CDC.
The FDA had hoped to announce its decision as early as
Thursday, the people familiar with the deliberations said, but agreed to wait
until Monday because Walensky said she wanted to hear recommendations from her
agency’s outside advisory group before signing off on the changes. That group,
which has met throughout the pandemic to consider FDA decisions around
vaccines, might not meet until Wednesday.
The two agencies share responsibility for setting the
nation’s vaccine policy and have worked to present a unified front in their
reviews of booster shots. But the FDA has been more willing to act without the
advice of its outside advisory committee, with some top officials arguing that
the agency needs to respond as quickly as possible in the face of the ongoing
public health crisis.
Federal regulators based their decision at least in
part on data from Israel that showed no serious safety concerns in thousands of
12- to 15-year-olds who received a third dose of the Pfizer vaccine. There were
no reports of myocarditis, a rare side effect seen mostly in younger men that
has been linked to the Pfizer and Moderna vaccines. The condition involves
inflammation of the heart muscle.
The FDA wants to allow a booster dose as early as five
months after the second Pfizer dose in part because Israeli data suggests that
the shorter interval is effective, according to people familiar with the
government’s deliberations.
One recent South African study showed that the
effectiveness of Pfizer’s vaccine against severe illness and hospitalization was
about 70% after two doses.
Pfizer and BioNTech, its German partner, have both
said their studies show that a third dose is needed to protect against omicron.
Dr Albert Bourla, the CEO of Pfizer, said earlier this month that while two
doses may still prevent severe disease from omicron, a third strengthens
protection.
Dr Ugur Sahin, the CEO of BioNTech, said three doses
“could still offer a sufficient level of protection from disease of any
severity” caused by the variant.
Although the FDA convened its outside advisory
committee repeatedly earlier this year, it has not asked the committee for
recommendations before its most recent decisions to expand boosters.
Walensky earlier this month endorsed offering
Pfizer-BioNTech booster shots to 16- and 17-year-olds without convening her
agency’s expert committee. But she was unwilling to do that for younger
adolescents, people familiar with the government’s deliberations said.
Some outside experts have argued that by bypassing the
outside committees, the CDC and FDA were wrongly limiting public discussion
about the evidence to justify expanding the use of boosters.
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