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Submitted URL: https://order.weshield.us/e3t/Ctc/RI*113/cZZj304/VVPHK97bTLphW6M92Sh7F4y0wVyCbyQ4R-1wRN2z6H2D3lLBGV1-WJV7CgR7GW4zR_j01HNmg...
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AFTER PROMISING TRIAL RESULTS FOR MATERNAL RSV VACCINE, PFIZER SAYS IT WILL SEEK
FDA APPROVAL THIS YEAR

By Brenda Goodman, CNN
Published 6:30 AM EDT, Tue November 1, 2022
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'It's awful': Doctor explains RSV symptoms as cases surge
04:03 - Source: CNN
CNN  — 

Pfizer says it has enough promising data on its respiratory syncytial virus, or
RSV, vaccine designed to protect newborns that it will end enrollment in the
study and submit for US Food and Drug Administration approval by the end of the
year.

RSV is a common respiratory virus that typically causes mild, cold-like
symptoms, but it can cause serious illness, particularly in older adults and
infants. Pfizer’s vaccine candidate is administered to pregnant women who then
make antibodies that cross the placenta and protect the baby after birth.

Scanning electron micrograph of human respiratory syncytial virus (RSV) virions
(colorized blue) that are labeled with anti-RSV F protein/gold antibodies
(colorized yellow) shedding from the surface of human lung epithelial A549
cells. RSV is a common contagious virus that infects the human respiratory
tract.
NIAID

By the next RSV season, the US may have its first vaccine

“The [study data monitoring committee] recommended, based on the data that we
have, that we should go ahead and file, that this offers the potential for a
safe and effective vaccine that could really dramatically help to prevent RSV
during the winter season,” Dr. William Gruber, Pfizer’s senior vice president of
vaccine clinical research and development, told CNN.

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In the trial, the vaccine was given to pregnant people and appeared to be about
80% effective at preventing severe RSV disease in their infants in the first
three months of life. It also cut a baby’s risk of needing to see a doctor for
an RSV infection by half.


POTENTIAL FOR FIRST NEW PRODUCT IN DECADES

If approved, Pfizer’s inoculation will be the first against RSV and the first
new product related to the infection in over two decades.

In March, the FDA designated Pfizer’s RSV vaccine a breakthrough therapy, a
status that speeds its review.

“That puts us in a very good position to essentially have something well in
advance of next winter,” Gruber said, noting that both Pfizer and the FDA are
conscious of the ongoing heavy RSV season in the US.

Mother is using digital medical electronic thermometer measures temperature of
the kid or patient. medical illness and fever concept.
Narisara Nami/Moment RF/Getty Images

Parents of younger children, how are you dealing with RSV and the flu?

“It will be up to them whether or not they can think of any other path that
could allow this to come sooner,” he said.

Pfizer’s vaccine contains the virus’ F-protein, the site that it uses to attach
to human cells. The protein is frozen into the shape it folds into before it
fuses with a cell, so the immune system can build antibodies against it.
Pfizer’s RSV vaccine is bivalent, containing F-proteins from both the A and B
subgroups of the RSV virus, which are the two most commonly circulating strains.

In a study of 7,400 pregnant people and infants, the vaccine was 82% effective
at preventing severe lower respiratory tract infections in hospitalized babies
for the first three months of life. It was about 70% effective at preventing
severe RSV in hospitalized infants for six months.

Babies were considered to have severe RSV if they were breathing very rapidly,
over 70 breaths per minute in a 2-month-old; if their blood oxygen levels fell
below 93%; if they required high-flow oxygen, or if they were admitted to the
ICU; or if they lost consciousness.

With hospital beds in short supply, Mattie McKoy waited three weeks for scans in
Atlanta.
Katie McKoy

While respiratory viruses surge, shortage of pediatric hospital beds delays care
for some kids

The vaccine cut the need for infants to need to see a doctor because of RSV by
an average of more than 50% compared with a placebo. That result did not fall
within a statistical range that was specified by the FDA before the outset of
the trial, however, so the company acknowledges that the vaccine missed that
particular goalpost.

Gruber points out, however, that a 50% reduction in doctor visits due to RSV is
still likely to be a noticeable and important benefit in the real world.

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“This is clearly sufficient and frankly, great news, for filing for our
approval,” he said.

Pfizer also recently announced positive results in an ongoing trial of the same
vaccine in older adults.


LONGER-TERM RESEARCH

The drugmaker’s FDA filing would make it the first in a crowded field of
companies developing vaccines against RSV. GSK had been testing a maternal
vaccine but paused its study after learning of a safety problem.

Courtesy Amanda Bystran

One twin lost his life to RSV, now his parents are waiting to find out if his
brother will survive the same illness

GSK said Monday that the trial remains stopped, though it did not share any
details on the safety issue.

“Further analysis to better understand safety data from these trials is
ongoing,” spokesperson Alison Hunt said in a statement to CNN. “The relevant
regulatory authorities and trial investigators have been informed. We’re
committed to transparently sharing more data as we have it.”

No safety issues have been identified with Pfizer’s vaccine, Gruber said, and a
panel of independent reviewers that looks over the study findings while the
trial is progressing found no problems.

“The vaccine is very tolerable, and no safety signals were identified,” he said,
though the full results of the trial have not been published.

Although Pfizer will suspend enrollment in the maternal vaccination trial,
Gruber says it will continue to follow the infants who are enrolled.


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Sign up here to get The Results Are In with Dr. Sanjay Gupta every Tuesday from
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“We know that children that have RSV end up having compromised lung status, and
they become more susceptible, in many instances, to other respiratory infections
that puts them back in the hospital. So we’re very interested in determining
does this not only have a specific effect as the vaccine was intended to have
against protection against RSV, but it may have a side benefit of allowing these
children to fare better over the longer term,” he said.


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