FDA Recommends New Dangerous Pfizer Injection

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Pfizer has another dangerous injection down the pipeline that the U.S. Food and Drug Administration (FDA) appears poised to approve.

The pharmaceutical giant is developing an RSV (respiratory syncytial virus) ‘vaccine’ for people ages 60 and up.

On Tuesday, the FDA gave the first green light for Pfizer’s new shot.

The FDA’s independent Vaccines and Related Biological Products Advisory Committee recommended the shot in a 7-4 vote.

According to Pfizer, the injection’s efficacy ranged between 67% to 86%

RSV disease is characterized by several respiratory symptoms varying from mild to more severe disease, with more severe disease having more symptoms. A pre-planned, interim analysis of Pfizer’s RSVpreF efficacy conducted by an independent, external Data Monitoring Committee (DMC) to assess protection against RSV-associated lower respiratory tract illness (LRTI-RSV) defined by two or more symptoms demonstrated vaccine efficacy: 66.7% (96.66% CI: 28.8%, 85.8%). This positive result enabled Pfizer to look at the more severe disease primary endpoint of LRTI-RSV defined by three or more symptoms, where vaccine efficacy of 85.7% (96.66% CI: 32.0%, 98.7%) was observed. The DMC also indicated the investigational vaccine was well-tolerated, with no safety concerns. Based on these results, Pfizer plans to submit a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for RSVpreF and to prepare submissions for other regulatory authorities in the coming months.

“We are delighted that this first bivalent RSV vaccine candidate, RSVpreF, was observed to be efficacious in our clinical trial against this disease, which is associated with high levels of morbidity and mortality in older adults,” said Annaliesa Anderson, Ph.D., Senior Vice President and Chief Scientific Officer, Vaccine Research and Development, Pfizer. “Scientists and researchers have worked to develop RSV vaccines with little success for over half a century. These findings are an important step in our effort to help protect against RSV disease, and we look forward to working with the FDA and other regulatory agencies to make this vaccine candidate available to help address the substantial burden of RSV disease in older adults.”

If the FDA grants final approval to Pfizer’s shot, it would be the country’s first RSV ‘vaccine.’

The next step is for the FDA to approve the vaccine, which could take several months, even though the agency usually follows the advisory committee’s recommendations. After FDA approval, the Centers for Disease Control and Prevention must recommend the shot before it becomes available to the public. If all of that happens, it would be the first RSV vaccine to get approved in the U.S.

The second may be close on its heels. The advisory committee will meet again Wednesday to evaluate the safety and efficacy of a similar RSV vaccine for older adults, this one from GlaxoSmithKline. Trial data published this month in the New England Journal of Medicine showed that the shot lowered the risk of symptomatic illness by 83% and of severe illness by 94% in people ages 60 and up.

RSV causes lower respiratory illness, although for most healthy adults the symptoms are mild. In serious cases, however, RSV can lead to bronchiolitis, which inflames airways and clogs them with mucus, or pneumonia.

Unsurprisingly, the FDA won’t properly inform the American public about the known risks of the RSV shot.

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The agency admits Guillain-Barre syndrome is a “possible risk” of Pfizer’s RSV injection.

In the phase three clinical trial, two shot recipients in their 60s developed Guillain-Barre syndrome.

GlaxoSmithKline’s RSV shot also had concerning safety signals.

The company had to halt phase three clinical trials.

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