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Booster shots approved for all vaccines

CDC also authorizes “mix n’ match” approach

The Centers for Disease Control and the U.S. Food and Drug Administration (FDA) announced last week that emergency use authorizations have been granted for the Moderna and Johnson & Johnson vaccine booster shots. This means that all three of the vaccine types in use within the United States have now received approval for the booster program.

The FDA and CDC have also given approval to “mix n’ match” booster doses, which means the booster shot does not have to be the same brand as the original vaccine a person received.

“The available data suggest waning immunity in some populations who are fully vaccinated,” said Acting FDA Commissioner Janet Woodcock, M.D., in the announcement.

“The availability of these authorized boosters is important for continued protection against COVID-19 disease.”

Most Crook County residents who were vaccinated here during the early days of the program received either the Moderna version from Public Health or the Johnson & Johnson version through an agency such as Veterans Affairs.

Crook County Public Health now has a call list available for booster shots and will be hosting its first booster clinic for people aged 65 and above on October 28. If you would like to be added to the list to receive your booster after the appropriate time has lapsed since your initial shots, call 283-1142.

Public Health will ask for your name, contact information and the date of your second dose if you received the Moderna or Pfizer vaccine, or your single dose if you received Johnson & Johnson. If you have not been vaccinated yet and would like to, Public Health is still offering regular opportunities to do so; call the office to schedule an appointment.

Wyoming remains the second most vaccine-hesitant state in the nation, according to data from the U.S. Census Bureau, with just 67% of residents vaccinated. Crook County is reported to be the most vaccine hesitant county in the state, with the Wyoming Department of Health reporting just 22.39% vaccinated on October 18.

Of the 25.3% of people in Wyoming who reported being hesitant about the vaccines, the top three reasons given were lack of trust in the government (58.1%), lack of trust in the vaccines (46.2%) and concern about the side effects (33.9%).

Booster Types

The FDA has approved a single booster dose of the Moderna vaccine to be administered at least six months after a person received their second shot. The Moderna booster is half of the dose originally administered.

It is now authorized for people aged 65 and older; people aged 18 to 64 who are at high risk of severe COVID-19; and people aged 18 through 64 with frequent exposure to COVID-19 through their workplace or living situation.

The FDA has also approved the use of a single booster dose of the Johnson & Johnson vaccine at least two months after a person received their first dose. It is now authorized for anyone over the age of 18.

Booster doses of the Pfizer vaccine were already authorized at the time of the announcement for those over the age of 65; between 18 and 64 with underlying medical conditions; between 18 and 64 and at increased risk due to their workplace or living situation; or residents of a long-term care setting. The Pfizer boosters can be administered at least six months after receiving the second of the two initial shots.

“We will work to accrue additional data as quickly as possible to further assess the benefits and risks of the use of booster doses in additional populations and plan to update the healthcare community and public with our determination in the coming weeks,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research.

FDA Approval

The FDA authorized the Moderna boosters after analyzing immune response data from 149 participants in the original clinical studies who were given a booster. These were compared to the immune responses of 1055 people who did not.

The antibody response of the 149 people who received another dose demonstrated a booster response, according to the FDA. The organization also evaluated analysis from Moderna comparing the rates of COVID-19 during the Delta variant surge, which suggest there is a waning of vaccine effectiveness over time.

Safety was evaluated by following 171 participants for an average of six months.

Authorization for the Johnson & Johnson booster is based on FDA evaluation of immune response data in 39 participants, who received a booster dose. The results demonstrated a booster response.

Approximately 9000 clinical trial participants have received two doses of the vaccine two months apart and, of those people, 2700 have had at least two months of safety follow-up. These studies have not identified new safety concerns.

Side Effects

The FDA has acknowledged that certain common side effects are associated with the Moderna booster shots. The most common reported side effects include pain at the injection site, tiredness, headache, muscle or joint pain, chills, swollen lymph nodes, nausea and vomiting and fever. Swollen lymph nodes in the underarm were observed more frequently after the booster than the initial two-dose series.

The FDA and Centers for Disease Control (CDC) have identified that there is an increased risk of inflammatory heart conditions, myocarditis and pericarditis after vaccination with the Moderna version, especially after the second dose. The risk is higher among males under 40 years of age, particularly between the ages of 18 through 24.

Early analyses by the FDA and CDC suggest there may be an increased risk of a rare type of blood clot in combination with low blood platelets after the Johnson & Johnson vaccine is administered. “Thrombocytopenia Syndrome” has been reported around one to two weeks after vaccination and has been highest in females aged 18 through 49.

Also, the data suggests there may be an increased risk of Guillain Barré syndrome, a serious neurological disorder, within 42 days of receiving this vaccine.