As fall approaches, many Montgomery County residents are being urged to stay on top of their annual vaccinations by healthcare experts. However, unlike in years past, the U.S. Department of Health and Human Services and the Food and Drug Administration have made some major vaccine policy changes this week that could affect who is eligible to be covered by health insurance and Medicaid.
COVID-19 Vaccine Updates
On Wednesday, Aug. 27, the FDA approved the updated vaccines from Pfizer, Moderna, and Novavax. However, the agency will limit who can get the shots. The updated COVID-19 vaccine will target the latest JN.1 variants. While the FDA has issued its approval, the Centers for Disease Control and Prevention also will weigh in. The agency’s Advisory Committee on Immunization Practices (ACIP) will meet next month. It is expected committee members will make its recommendations on the COVID-19 vaccine and who should be eligible.
FDA Guidance Changes
MCM spoke with Sean O’Donnell, Montgomery County’s deputy chief of public health. He outlined what people can expect this fall.
“This labeling guidance limits the vaccine to individuals 65 and older, and those between 16 and 64 years old with at least one condition that puts them at high risk for severe outcomes from COVID-19. The CDC’s evidence-based high risk list covers a significant portion of the U.S. adult population including pregnant people, smokers, people with diabetes, cancer or mental health conditions to name a few. Most pharmacies and many providers do not require proof beyond an individual’s attestation that they have one of these conditions,” O’Donnell said.
He cautions while it may be possible for younger people and those not at high risk to receive the vaccine, some doctors may be reluctant to prescribe the shot while some pharmacies also may hesitate to fill an order. O’Donnell said it also is unclear if insurance companies will cover the cost of the vaccine in these lower risk cases.
“The FDA guidance does not explicitly include the vast majority of other individuals where the science has clearly shown that updated COVID-19 shots continue to reduce disease transmission, severity and death. This limitation is contrary to the evidence-based approach that has been employed since the beginning of the pandemic,” O’Donnell added.
Opposition to FDA Decision
Some health groups disagree with the FDA’s decision. The American Association of Pediatrics issued a recommendation last week that all children ages 6 months through 23 months receive a coronavirus vaccine to help protect against serious illness, particularly ahead of the fall-winter respiratory season.
“This age group is less likely to have immunity from prior exposure and the COVID-19 vaccine has been shown to be a far safer way to develop immunity than through infection,” O’Donnell explained.
He also said it is important for pregnant women to receive a COVID-19 vaccine since infants cannot receive the shot until they are 6-months old. He expects outside groups such as the Vaccine Integrity Project will provide their guidance.
“This type of conflicting opinion rarely happens, so it may add to confusion,” O’Donnell said.
Bringing Attention to Vaccines
The FDA’s announcement comes as National Immunization Awareness Month comes to a close. This annual observance during the month August began in 2013. It was started to highlight the importance of getting recommended vaccines at different stages of a person’s life. Many doctors say they now worry about messages coming out of Washington D.C. and the Trump Administration. They fear those messages could negatively influence some people and cause them to shun vaccines for themselves and their children.
HHS Secretary Robert F. Kennedy, Jr. previously embraced anti-vax positions before becoming the head of the department. However, the HHS officials have said the policy changes it has made in recent months will help restore public trust in vaccines, and improve systems to monitor vaccine safety.
Flu Vaccine Changes
Meantime, HHS also is making a small change to flu vaccines. The department announced in July it was removing the mercury-based chemical, Thimerosal, from all flu shots. Thimerosal is a preservative. It was used in flu shots to make them safe from harmful bacteria. However, the U.S. health authorities removed Thimerosal from vaccines in 1999 as a precaution. Studies show the preservative did not cause any harm.
“Currently, only 4 to 7 percent of the manufactured flu vaccine supply contains Thimerosal; so this should not have an immediate impact on availability or effectiveness of the flu vaccine,” O’Donnell said.
Critics of the move say the CDC’s advisory panel voted to ban flu shots containing Thimerosal, not because of scientific evidence but because of falsehoods. The newsletter, Your Local Epidemiologist voiced that opinion in its June edition. The newsletter reported that Thimerosal is used in vaccines around the world and its authors stated in their opinion that the preservative is incredibly important for pandemic preparedness and that banning its use could harm future vaccine production in the case of another disease threat.
mRNA Funding Cut
Another change involves the future of mRNA vaccines. Drug makers like Pfizer and Moderna used the technology to help create the COVID-19 vaccines when the pandemic hit in March 2020. Earlier this month, Sec. Kennedy announced the federal government is cancelling $500 million for research into mRNA vaccines. Most of the cancelled projects were to fight COVID-19 and the flu.
“HHS has determined that mRNA technology poses more risk than benefits for these respiratory viruses” Kennedy said.
Montgomery County Executive Marc Elrich reacted last week to the government’s decision.
“We have clear evidence that the mRNA COVID-19 vaccines are effective at reducing the severity of infection and have saved tens of millions of lives. Removing investments in mRNA technology will mean that the United States will no longer be the international leader in this crucial biotechnological field and will make us dependent on developments made in other countries that continue to invest heavily in mRNA research,” Elrich said.
Meanwhile, the county’s public health chief reminded everyone of what life was like before vaccines to fight COVID-19 were released to the public.
“Our hospitals were overwhelmed by patients, many of whom were seriously ill. Hospitalization numbers went down once people started getting the vaccine. Imagine if we had relied on the old system of producing a vaccine. We may still be dealing with this as a national health crisis today,” O’Donnell added.
Benefits of Vaccines
The county’s Health Department is encouraging residents to get their annual flu shots, COVID-19 vaccines, and RSV shots if they are eligible.
“The benefits of vaccination are two-fold: first, it benefits the individual in decreasing his or her risk of severe illness. Secondly, the more people vaccinated, the lower the risk of illness spreading throughout the community,” O’Donnell said.
Vaccine Availability
Flu, COVID-19 and RSV shots should be available in September. The county Health Department will receive some flu shots it can distribute for children and adults without insurance. O’Donnell recommends flu shots for anyone 6 months old and older. He said people who do not like to get a shot in the arm can opt for FluMist which is a nasal spray. FluMist will be available in doctor’s offices and pharmacies. A patient also can take a dose of FluMist at home.
O’Donnell recommends RSV shots for pregnant women, infants up to 18 months old, and older residents. The vaccine remains the same as in years past.
“The public health community continues to strongly promote the benefits of vaccines based on scientific evidence. We will closely monitor any changes to vaccine schedules and recommendations,” O’Donnell said.
