FDA Advisers Back Maternal RSV Vaccine as Pfizer Says Safety Concerns Can Be Studied Post-Approval

The Epoch Times Header

Advisers to the U.S. Food and Drug Administration (FDA) voiced support on May 18 for Pfizerโ€™s maternal RSV vaccine even after several expressed concerns over premature births.

Outside experts on the Vaccines and Related Biological Products Advisory Committee unanimously said data from two trials run by Pfizer were sufficient to support the vaccine being effective at preventing RSV disease in infants. They also voted 10โ€“4 in the affirmative when asked if the data from the trials were sufficient to demonstrate the safety of the vaccine.

The votes set up FDA clearance for what would be the first maternal vaccine for the respiratory syncytial virus, or RSV.

Pfizerโ€™s vaccine, a recombinant protein subunit shot, targets the RSV A and RSV B subgroups in a 120 microgram dose that would be given to pregnant women in the second or third trimester. The goal would be to relay antibodies against RSV to fetuses, conferring protection that is supposed to last through the first year of life.

The vaccine was 81.8 percent efficacious through 90 days after birth against severe lower respiratory tract illness due to RSV. The efficacy dropped to 69.4 percent after another 90 days.

For any RSV-positive medically attended lower respiratory tract illness, the vaccine started at 57.1 percent efficacy and dropped to 51.3 percent over the same timeframe, according to data from a phase 3 trial that included about 3,500 vaccinated pregnant women.

The efficacy for medically attended lower respiratory tract illness from any cause was just 2.5 percent at 180 days and 5.1 percent at 360 days.

FDA staffers said in a briefing document that the trial showed โ€œsuccessful vaccine efficacy, and the advisers seconded that view with their unanimous vote.

But multiple experts expressed concerns about the risk of the vaccine causing premature births, a risk found in a similar product made by GlaxoSmithKline that prompted the company to halt testing in 2022.

In Pfizerโ€™s trial, there were more premature deliveries in the vaccinated arm than the placebo armโ€”5.7 percent in the former versus 4.7 percent in the latter.

โ€œThat is hanging over this program,โ€ Dr. Paul Offit, one of the FDAโ€™s advisers, said during Thursdayโ€™s meeting.

By Zachary Stieber

Read Full Article on TheEpochTimes.com

The Epoch Times
The Epoch Timeshttps://www.theepochtimes.com/
Tired of biased news? The Epoch Times is truthful, factual news that other media outlets don't report. No spin. No agenda. Just honest journalism like it used to be.

Beijing and Moscow Double Down on Propping Up Tehran, Threaten to Give It Nukes

As anyone who understands how these things unfold could...

The Looming Threat To Our Homeland

After success of โ€œOperation Midnight Hammer,โ€ where U.S. military bombed Iranian nuclear facilities, the threat to America has never been greater.

Trumpโ€™s Bold Strike on Iran: A Necessary Move for Global Securityย 

Trumpโ€™s airstrikes on Iranโ€™s nuclear facilities have been hailed as a courageous and necessary action to safeguard American interests and global stability.

Groundhog Day came late this year to the Land of Smiles.

itโ€™s the same rigmarole, on whatever pretext, the army commandeers the Thai state with vague promises to restore democracy at some unspecified future date.

Resource number one

Russia has an unsustainable birthrate worsened by mortality rate of Russian males through war and alcoholism. One solution, steal young children from other countries.ย 

Boeing, FAA Share Blame for Door Panel Flying Off During Alaska Airlines Flight: NTSB

The sudden midair door panel blowout on Alaska Airlines flight last year stemmed from failures by Boeing, its supplier Spirit AeroSystems, and the FAA.

RFK Jr. Says Pregnant Women Can Get COVID-19 Vaccine If They Choose To

Pregnant women can get COVID-19 vaccines, even after CDC stopped recommending shots during pregnancy, Sec. RFK, Jr. told members of Congress.

Texas Governor Signs Law Requiring Warning Labels on Some Foods

Texas is requiring companies to add warning labels to some foods, under the Texas MAHA legislation bill signed into law by Gov. Greg Abbott.

21.8 Million US Seniors Paying for Expenses With Only Social Security Income: Survey

An estimated 21.8 million senior citizens in America make ends meet solely using their social security funds, The Senior Citizens League (TSCL) said.

Trump Arrives in Netherlands for NATO Summit, With Defense Spending High on Agenda

President Donald Trump arrived in Amsterdam on Tuesday to attend the NATO summit, which is being held in The Hague from June 24 to 25.

Major Victory for Trump Administration and the American People on Deporting Criminal Illegal Aliens to Third Countries

Supreme Court decision allows DHS to deport criminal illegal aliens who are not wanted in their home country to third countries who've agreed to accept them.

No Changes Planned for FDAโ€™s Vaccine Advisory Committee โ€˜At This Timeโ€™: Spokesperson

There are no plans to remove any members of the panel that advises the FDA on vaccines, a spokesperson said on June 20.

Trump Says Trade Deals Expected With India and Pakistan

President Trump expects US will sign trade deals with India and Pakistan, signaling growing momentum in push to reshape global trade through tariff diplomacy.
spot_img

Related Articles