Pfizer Developing RSV Vaccine to Immunize Unborn Babies While in the Womb

Pharmaceutical giant Pfizer is developing a vaccine specifically for pregnant women that will immunize an unborn baby while still in the womb.

Pfizer claims that infants will be protected against the respiratory syncytial virus (RSV) after birth.

RSV effects 97% of children by age 2. It has a 99.9976% survival rate. There is no need for a vaccine for it.

Yet Pfizer has decided that RSV can serve as a revenue stream, & they've created a maternal "vaccine" for it.

They will submit it to the FDA for approval by EOY.

— Jordan Schachtel @ dossier.today (@JordanSchachtel) November 2, 2022

Pfizer announced Tuesday that its maternal RSV vaccine, given during pregnancy, protected infants from developing severe symptoms during the first six months after birth — a critical window of vulnerability. https://t.co/cwrQcnyHvs

— The Washington Post (@washingtonpost) November 1, 2022

Huge news for the babies!

Pfizer’s bivalent RSV vaccine has demonstrated amazing efficacy (81.8% against severe lower respiratory illness). This was well tolerated and with results meeting criteria, Pfizer has stopped enrollment and will plan to submit by end of 2022! pic.twitter.com/dObCKEjBJT

— Dr. Neuro 🏳️‍🌈 🦠💉💪 (@Neurofourier) November 1, 2022

According to the CDC:

Respiratory syncytial (sin-SISH-uhl) virus, or RSV, is a common respiratory virus that usually causes mild, cold-like symptoms. Most people recover in a week or two, but RSV can be serious, especially for infants and older adults. RSV is the most common cause of bronchiolitis (inflammation of the small airways in the lung) and pneumonia (infection of the lungs) in children younger than 1 year of age in the United States.

RSV cases have increased in the United States and Canada.

However, The Highwire reviewed FDA documents from Pfizer and Moderna’s COVID-19 injection clinical trials that suggest the experimental mRNA shots may be responsible for the surge.

Massive Surge in RSV Across U.S. and Canada! What’s to Blame?

Pfizer made the announcement regarding its RSV vaccine:

• Vaccine efficacy of 81.8% was observed against severe medically attended lower respiratory tract illness due to RSV in infants from birth through the first 90 days of life with high efficacy of 69.4% demonstrated through the first six months of life
• The RSVpreF investigational vaccine was well-tolerated with no safety concerns for both vaccinated individuals and their newborns
• Results met one of the study protocol’s pre-specified regulatory success criteria, and Pfizer plans to submitits first regulatory application by end of 2022
• If approved, Pfizer’s RSV vaccine candidate could be the first maternal vaccine available to help prevent this common and potentially life-threatening respiratory illness in young infants
• Pfizer currently the only company with an investigational vaccine being prepared for regulatory applications for both infants through maternal immunization and older adults to help protect against RSV

NEW YORK--(BUSINESS WIRE)-- Pfizer Inc. (NYSE: PFE) today announced positive top-line data from the Phase 3 clinical trial (NCT04424316) MATISSE (MATernal Immunization Study for Safety and Efficacy) investigating its bivalent RSV prefusion vaccine candidate, RSVpreF or PF-06928316, when administered to pregnant participants to help protect their infants from RSV disease after birth.

The pre-planned, interim efficacy analysis conducted by an external and independent Data Monitoring Committee (DMC) met the success criterion for one of two primary endpoints. The observed efficacy for severe medically attended lower respiratory tract illness (severe MA-LRTI) was 81.8% (CI: 40.6%, 96.3%) through the first 90 days of life. Substantial efficacy of 69.4% (CI: 44.3%, 84.1%) was demonstrated for infants over the six-month follow-up period.

Although the statistical success criterion was not met for the second primary endpoint, clinically meaningful efficacy was observed for MA-LRTI of 57.1% (CI: 14.7%, 79.8%) in infants from birth through the first 90 days of life. Efficacy for MA-LRTI of 51.3% (CI: 29.4%, 66.8%) was observed over the six-month follow up period.

Pre-planned safety reviews conducted at regular intervals throughout the duration of the study by the DMC also indicate the investigational vaccine is well-tolerated with no safety concerns for both the vaccinated individuals and their newborns.

“We are thrilled by these data as this is the first-ever investigational vaccine shown to help protect newborns against severe RSV-related respiratory illness immediately at birth,” said Annaliesa Anderson, Ph.D., Senior Vice President and Chief Scientific Officer, Vaccine Research & Development, Pfizer. “These data reinforce Pfizer’s resolve to bring our expertise in the research and development of innovative vaccines to address critical public health needs using new approaches and technologies. We look forward to working with the FDA and other regulatory agencies to bring this vaccine candidate to expectant mothers to help protect their infants against severe RSV during their most vulnerable first six months of life, which has the highest burden of RSV illness in infants. We would like to thank the pregnant women who volunteered for this trial, along with their infants, and all the investigators around the world who participated in the study for their contribution to this landmark research.”

WATCH:

God will not agree!

“Pfizer have declared they will be giving out a new vaccine called the PH111 to be given specifically to pregnant women, which will be immunising a newborn baby while still in the uterus”

We must stop Pfizer now before they kill any more children! pic.twitter.com/j4JU7LjRUT

— The Mad Hatter (@GeraldAvery17) November 7, 2022

Endpoints News reported:

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Pfizer is stopping enrollment in its Phase III MATISSE trial after it met one of two primary endpoints at an interim analysis by the external data monitoring committee. As measured by severe medically attended lower respiratory tract (MA-LRTI) illness through the first 90 days of life, the committee found an efficacy of 81.8% (CI: 40.6%, 96.3%). The number fell to 69.4% over the six-month follow-up period.

The vaccine, dubbed RSVpreF, didn’t meet the bar on the second primary endpoint of lowering any MA-LRTI. Pfizer reported “clinically meaningful” efficacy of 57.1% from birth through the first 90 days of life, then 51.3% over the six-month follow-up.

And it’s not stopping the company from shooting for a BLA filing by the end of this year.

It hasn’t been easy. Novavax’s RSV vaccine candidate flunked a Phase III study back in 2019, and earlier this year GSK halted development of its own program after flagging safety concerns.

Sanofi and AstraZeneca, on the other hand, recently notched an EU approval for their antibody, nirsevimab.

Just like nirsevimab, Pfizer’s RSVpreF was granted a breakthrough therapy designation by the FDA.