GSK’s RSV Vaccine Triumphs: Adcomm Approval Just One Day After Pfizer’s Defeat!

The U.S. Food and Drug Administration’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) has given a ringing endorsement to GlaxoSmithKline’s respiratory syncytial virus vaccine candidate, finding it safe and effective for use in older adults. This is a major step forward in the fight against the virus, which can cause serious respiratory problems.

The committee voted with a unanimous 10-2 in favor of the data published in the New England Journal of Medicine which supports the effectiveness and safety of the vaccine. The data presented was met with great enthusiasm, showing a strong confidence in the vaccine’s efficacy and safety.

If approved, it would be the first ever RSV vaccine available for adults aged 60 and over, marking a major milestone in the fight against this common virus. But only if it can beat Pfizer to the finish line!

The decision to approve GSK’s candidate, made by the same committee just a day after it gave Pfizer’s RSV vaccine RSVpreF the green light for use in older adults, marks a major milestone in the battle against respiratory syncytial virus (RSV).

GSK has stolen a march on Pfizer in the RSV race, emerging triumphant with its priority review granted a month earlier than its rival.

GSK’s vaccine candidate has demonstrated impressive efficacy, with an 82.6% success rate in preventing RSV-confirmed lower respiratory tract disease (LRTD) in adults aged 60 and above. Even more impressive is its success in preventing severe LRTD in those aged 70 to 79, making it a promising solution for an age group particularly vulnerable to RSV.

After a closely-contested vote, the Vaccines and Related Biological Products Advisory Committee (VRBPAC) ultimately approved Pfizer’s RSV vaccine candidate, 7-4. The panel was just as evenly divided when it came to evaluating the vaccine’s efficacy data, with one abstention. Despite the split decision, the Committee was convinced that the safety and efficacy data presented by Pfizer was sufficient.

At the meeting, Pfizer presented promising Phase III efficacy and safety data for its RSV vaccine, with an impressive 66.7% efficacy rate in preventing lower respiratory tract infections (LRTI) with at least two symptoms during the first RSV season. Topping out at an incredible 85.7% efficacy rate when considering LRTI episodes with at least three symptoms, these results provide immense hope for a successful vaccine.

Pfizer’s vaccine candidate was found to be largely safe, with mostly mild or moderate local and systemic reactions reported. Adverse events, though some were serious or life-threatening, were balanced between those receiving the vaccine and those receiving a placebo.

The VRBPAC highlighted two cases of Guillain-Barré syndrome (GBS) among 19,942 vaccinated participants as a potential risk linked to the Pfizer vaccine, noting that it was higher than the baseline rate of 1.5 to 3 cases per 100,000 people. The panel deemed these GBS cases to be an important potential risk.

The VRBPAC also flagged one case of Guillain-Barré Syndrome (GBS) as being related to GSK’s vaccine, prompting GSK to take no further action – no safety trial was needed. This case highlighted the importance of monitoring the safety of vaccines, even after they have been approved for use.

The FDA has asked Pfizer to take precautionary measures and conduct a post-marketing safety study for its RSV vaccine. This includes including Guillain-Barré Syndrome and other immune-mediated demyelinating conditions in its pharmacovigilance plan in order to ensure the vaccine’s safety and effectiveness.

The FDA’s Advisory Committee is a powerful group of independent experts who offer their wisdom to the Agency. While their recommendations are not mandated, the FDA often follows their counsel. In May, the world will finally see the outcome of Pfizer and GSK’s RSV vaccines, thanks to the hard work of the Advisory Committee.

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