WASHINGTON, Feb 2, 2022 (BSS/AFP) - Pfizer and BioNTech said Tuesday they
are seeking emergency authorization from US health regulators for use of
their Covid vaccine for children aged over six months and under five years.

  If the Food and Drug Administration (FDA) authorizes the two-shot regimen,
it will become the first Covid vaccine available to this age group in the
United States.

  The companies said Tuesday that they started submitting their formal
application "following a request" from the FDA, which seemingly wants to get
the process moving quickly.

  In a tweet soon after the announcement, the FDA said it will hold a meeting
in two weeks, on February 15, to consider the request.

  "Having a safe and effective vaccine available for children in this age
group is a priority for the agency," said interim FDA head Janet Woodcock,
who added that the FDA asked for the application "in light of the recent
Omicron surge."

  The companies are seeking authorization for only two doses of their
vaccine, but believe a third will be needed "to achieve high levels of
protection against current and potential future variants," Pfizer CEO Albert
Bourla said in a statement.

  "If two doses are authorized, parents will have the opportunity to begin a
Covid-19 vaccination series for their children while awaiting potential
authorization of a third dose," he added.

  To limit side effects for this young age group, Pfizer chose to
significantly decrease the dosage of its vaccine, opting for only three
micrograms per jab versus 30 for those over 12 years old, and 10 for ages
five to 11.

  The company's researchers concluded last fall that low doses of the vaccine
provided protection in children up to two years old but not in those aged two
to five, and announced in December they would add a third dose to their
trials.

  Data on the three-dose regimen is "expected in the coming months and will
be submitted to the FDA to support a potential expansion" of this initial
request, Pfizer and BioNTech said in the statement.

  If the FDA authorizes the emergency use of the vaccine, an advisory
committee for the Centers for Disease Control and Prevention (CDC) will then
meet to decide to recommend its use or not.

  - Slower uptake among minors -

  There are about 23 million children under the age of five in the United
States, and two years after the pandemic began, many parents are waiting
impatiently to vaccinate their young children against the coronavirus.

  The Pfizer-BioNTech vaccine was approved three months ago for emergency use
in children from five to 11, but uptake has been relatively slow.

  In that age group, only 30 percent have received at least one dose and
around 22 percent are fully vaccinated, according to the Centers for Disease
Control and Prevention (CDC).

  Young children are less susceptible to falling seriously ill with Covid-19,
but some nonetheless end up hospitalized by the virus.

  New pediatric Covid hospitalizations hit a record high in the United States
in December as the Omicron strain spread rapidly.

  Some cases of the life-threatening illness MIS-C (multi-system inflammatory
syndrome in children), have also been reported in young children with Covid.

  CDC data shows that about 400 children aged four and under have died from
Covid-19 in the United States since the pandemic began.