Moderna Seeking Regulatory Approval for Third RSV Vaccine for Americans 60 and Older

Moderna Seeking Regulatory Approval for Third RSV Vaccine for Americans 60 and Older

Legal Insurrection readers may recall that in 2021, I reported on a surge of respiratory syncytial virus (RSV) that resulted in hospitalizations.  Children were hard-hit, after resuming normal social interactions in the post-covid-lockdown world.

As a reminder, RSV is a common respiratory virus that usually results in mild cold-like symptoms. Most people recover in a week or two. Still, RSV can be severe, especially for infants. It is the most common cause of bronchiolitis (inflammation of the small airways in the lung) and pneumonia (infection of the lungs) in this country’s children younger than one year of age.

Moderna is now seeking approval from the Food and Drug Administration (FDA) for its RSV vaccine for people 60 and older.

“We are proud to announce these filings for the use of our RSV vaccine candidate, mRNA-1345, in the European Union, Switzerland, Australia, and the U.S.,” Moderna CEO Stéphane Bancel said in a statement.

“RSV is a major cause of lower respiratory tract infections in older adults and can cause a significant burden to health systems through hospitalizations and emergency care admissions,”

Moderna said the regulatory applications come after positive data from a study of approximately 37,000 adults 60 or older in 22 countries. Its vaccine to protect from respiratory syncytial virus was found in these trials to be 83.7% effective as defined by two or more symptoms.

According to the company, the vaccine was well-tolerated, with a favorable safety profile.

One month ago, Pfizer obtained approval for its version of the RSV vaccine shortly after GSK received its approval.

GSK was the first drugmaker to get the F.D.A.’s permission to market an R.S.V. vaccine on May 3. The vaccines are expected to be available in the fall before the winter R.S.V. season.

…During an advisory meeting on March 1 about both vaccines, doctors reviewed detailed data provided by the drugmakers.

Pfizer’s product, called Abrysvo, proved nearly 67 percent effective against cases of the virus with two symptoms and 86 percent effective against cases with three or more symptoms, according to data submitted to the F.D.A. The GSK vaccine, called Arexvy, was reported to be nearly 83 percent effective against R.S.V.

But the advisory panel also raised concerns about a few cases in which vaccine recipients developed autoimmune syndromes shortly after receiving the shots.

In a Pfizer study of about 34,000 patients who received the R.S.V. vaccine, a week after the shot, one patient developed a life-threatening case of Guillain-Barré syndrome, a condition where the immune system attacks the nervous system. A second patient developed a subtype of that condition called Miller Fisher syndrome eight days after receiving the shot.

Those cases put the incidence rate of the condition at about one in 9,000 — though they are typically seen at a rate of about one in 100,000 in the general population. Some advisers, also noting the low incidence of severe R.S.V. in the patient pool, found those numbers troubling. The final vote of the F.D.A.’s advisory panel in favor of the Pfizer vaccine’s safety and efficacy was 7 to 4. The panel voted 10 to 2 in favor of the GSK vaccine, which was also linked to one Guillain-Barré case and two others of a possibly related disorder.

The American media was quick to push the new product. Take this excerpt from The New York Times, which promoted the flu and covid vaccines as well.

Each year, about 60,000 adults 65 and older are hospitalized with R.S.V. and about 6,000 to 10,000 die from the virus, the F.D.A. estimated. The Centers for Disease Control and Prevention estimated that in one year, more than 21,000 people in that age group would need to take the GSK vaccine to prevent one R.S.V. death; the number was nearly 25,000 for the Pfizer shot.

The virus was a key driver in the winter’s “tripledemic” of Covid, flu and R.S.V. that was particularly hard on young children, resulting in overwhelmed hospitals.

…R.S.V. is increasingly recognized as a major respiratory threat, particularly to older adults, immunocompromised people and young children. “R.S.V. has a burden of disease similar to flu in older adults — it can make you very, very sick,” said Dr. Helen Chu, a physician and immunologist at the University of Washington.

However, given the increasing skepticism related to the reliability of data on adverse reactions to vaccines, many are wary of taking this shot to avoid a common respiratory virus that generally has mild effects.

RSV in adults is very rare and mild. Easy to treat. Not worth any risk or time on a vaccine. #courageousdiscourse @DrEliDavid @DrLoupis @denisrancourt @richardursomd @drcraigwax @BenMarble_MD @stkirsch @sonia_elijah @MaryanneDemasi https://t.co/6JXR2NNL0X https://t.co/yAgJikwsz0 pic.twitter.com/mlV2EESu5u

— Peter A. McCullough, MD, MPH™ (@P_McCulloughMD) July 6, 2023

Interestingly, many people are also turning away from the covid vaccine.

Germany has thrown out 83 million doses of coronavirus vaccines at a rough cost of €1.6 billion and has 120 million more doses sitting unused in stock, even as it is set to receive more jabs at a time when vaccination has flatlined.

According to data provided by the country’s health ministry, Germany scrapped 54 million COVID-19 vaccine doses by the end of 2022 and another 29 million in the first quarter of 2023.

However, the real tally is likely to be higher. The ministry didn’t provide waste figures for the second quarter of this year and also stressed that federal states and health care providers aren’t required to report vaccine waste. “Accordingly, a total volume of total disposed COVID-19 vaccine doses acquired by the Federal Republic of Germany cannot be quantified,” it said in an email to POLITICO.

Perhaps instead of racing to create new vaccines, the better approach would be to focus on detection and effective treatment of early stage symptoms. The public trust in new vaccines to solve every single illness mankind may experience seems to have evaporated.

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