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FDA Recommends New Dangerous Pfizer Injection


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.’

NBC News reported:

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.

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.

From CNBC:

The Food and Drug Administration sees a possible risk of Guillain-Barre syndrome with Pfizer’s RSV vaccine for older adults and has asked the company to conduct a safety study if the shot is approved this spring, according to agency briefing documents published Friday.

Two people in their 60s who received Pfizer’s shot were diagnosed with Guillain-Barre syndrome, out of about 20,000 vaccine recipients in the phase three trial, according to the FDA document. There were no cases in the trial’s placebo group, the people who didn’t receive the shot.

Guillain-Barre syndrome, or inflammatory neuropathy, is a rare disorder in which the body’s immune system mistakenly attacks the nerves. Symptoms range from brief weakness to paralysis, according to the National Institutes of Health. Most people recover, even from severe cases.

Pfizer, in its briefing document, said the cases have other possible explanations. But it said it will conduct a safety study to further assess Guillain-Barre syndrome after a potential approval. The company said it did not identify any safety concerns during the trial and the vaccine was well tolerated.

GlaxoSmithKline’s RSV shot also had concerning safety signals.

The company had to halt phase three clinical trials.

Fierce Biotech explained:

Hopes of a quick fix for GlaxoSmithKline’s respiratory syncytial virus (RSV) vaccine woes are fading fast. Having voluntarily paused three maternal RSV vaccine clinical trials 10 days ago, GSK has now stopped enrollment and vaccination in the studies as it works to better understand the safety data.

Details of the situation, which began when an independent data monitoring committee recommended a pause in response to a safety assessment, remain scarce. The latest update provides no information on the nature of the safety signal, but whatever GSK learned over the past 10 days persuaded it to stop rather than just pause its maternal RSV vaccine studies.

“GlaxoSmithKline today announced that, further to the voluntary pause shared on February 18, the Company has decided to stop enrolment and vaccination in trials evaluating its potential [RSV] maternal vaccine candidate in pregnant women. Further analysis to better understand safety data from these trials is ongoing, and the relevant regulatory authorities have been informed,” GSK wrote in a statement.

A phase 3 clinical trial in older adults is continuing as planned and is still scheduled to deliver data by the midpoint of the year. GSK had aimed to publish maternal data by the end of 2022. The centerpiece of the maternal RSV vaccine development program is the 20,000-subject GRACE trial. GSK has stopped that key trial and two smaller studies, one of which was yet to start recruiting when the safety signal emerged.

Unfortunately, the Pharma-owned FDA will most likely approve both RSV shots.

The agency operates to enrich pharmaceutical companies and not to improve public health.


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