Moderna Booster Update : Reported by FDA
Moderna Booster Update: Food and Drug Administration(FDA) took action to expand the use of a booster dose(Including Moderna Booster, Pfizer Booster and J&J Booster) for COVID19 vaccines in eligible Individuals. The agency is amending the emergency use authorizations (EUA) for COVID19 vaccines to allow for the use of a single booster dose as follows:
- The use of a single booster dose of the Moderna COVID19 Vaccine that may be administered at least 6 months after completion of the primary series to individuals:
- 65 years of age and older
- 18 through 64 years of age at high risk of severe COVID19
- 18 through 64 years of age with frequent institutional or occupational exposure to SARSCoV2
- The use of a single booster dose of the Janssen (Johnson and Johnson) COVID19 Vaccine may be administered at least 2 months after completion of the singledose primary regimen to individuals 18 years of age and older.
- The use of each of the available COVID19 vaccines as a heterologous (or “mix and match”) booster dose in eligible individuals following completion of primary vaccination with a different available COVID19 vaccine.
- To clarify that a single booster dose of the PfizerBioNTech COVID19 Vaccine may be administered at least 6 months after completion of the primary series to individuals 18 through 64 years of age with frequent institutional or occupational exposure to SARSCoV2.
“Today`s actions demonstrated our commitment to public health in proactively fighting against the COVID19 pandemic,” said Acting FDA Commissioner Janet Woodcock, M.D. “As the pandemic continues to impact the country, science has shown that vaccination continues to be the safest and most effective way to prevent COVID19, including the most serious consequences of the disease, such as hospitalization and death.
The available data suggest a weakened immune system in the fully vaccinated population. The availability of these approved boosters is important for continued protection against COVID 19 disease.
” Changes in approval to include a single booster dose in the appropriate population group are based on available data and information and are subject to member input. Of our advisory board that supported the use of booster immunizations of these vaccines in appropriate populations, “said Dr. Peter Marks, MD, director of the FDA’s Center for Biological Research and Evaluation.
“We are also taking action to include the use of mix-and-match boosters to meet this public health need. We have the benefits and risks of using booster doses in additional populations. We will strive to collect additional data as soon as possible to further assess our health community and the general public in the coming weeks.
Moderna Booster Update: Emergency Moderna COVID-19 Vaccine Booster Use.
To support the approval of multiple booster doses, the FDA analyzed immune response data from 149 participants over the age of 18 from the original clinical trial, where booster doses were performed at least 6 months later. The second dose was compared to the immune response of 1,055 study participants after completing the two-dose series. The antibody response of 149 participants to the SARSCoV2 virus 29 days after booster was a booster response. showed that.
The FDA also evaluated an additional analysis from Moderna comparing the percentage of COVID19 that occurred during the July and August 2021 delta variant surges, suggesting that vaccine efficacy declines over time.
Safety was assessed by 171 participants aged 18 years and older who were followed for an average of approximately 6 months.
In the recent Moderna Booster Update, the most commonly reported side effects from clinical study participants receiving booster vaccines are
- pain at the injection site,
- fatigue,
- headache,
- muscle and/or joint pain,
- cold air, and swelling of the lymph nodes in the same arm as the injection. ,
- Nausea, and vomiting
- Fever.
It is noteworthy that after the booster administration, swelling of the lymph nodes in the armpit was observed more often than after the first two doses.
Moderna Booster Update – Analysis By FDA & CDC
Risk of inflammatory heart disease, myocarditis, and pericarditis after vaccination with the Moderna COVID-19 vaccine, especially after the second vaccination, according to a continuous analysis by the FDA and the Centers for Disease Control and Prevention (CDC) safety monitoring system Was confirmed to increase.
Symptoms usually appear a few days after vaccination. The observed risk is higher in men under the age of 40, especially in men aged 18-24 than in women and older men. In the recent Moderna Booster Update, Moderna COVID19 single booster dose is half the basal dose and is given at least 6 months after the completion of the basal vaccine course.
Janssen (Johnson and Johnson) COVID19 Vaccine Booster Dose Approval
Janssen COVID19 Vaccine Single Emergency Booster Dose Approval in 39 Clinical Trial Participants, Including 24 Elderly People Aged 18-24 It is based on the evaluation of the FDA’s immune response data. 15 participants aged 55 and over 65.
Study subjects received a booster about 2 months after the first dose, and the results showed a booster immune response.
In total, approximately 9,000 clinical trial participants received two Janssen COVID19 vaccines at least every two months, of which approximately 2,700 received at least two months of safety follow-up after booster immunization. .. Janssen’s safety analysis from these studies did not reveal new safety concerns.
Previous analysis by the FDA and CDC safety monitoring systems suggests an increased risk of severe and rare types of platelets, coupled with low platelet counts, after administration of the Janssen COVID19 vaccine. This serious condition is known as Thrombocytopenia Syndrome (TTS).
People who developed TTS after vaccination began to have symptoms about 1 to 2 weeks after vaccination. TTS was most commonly reported in women aged 18-49 years. In addition, safety surveillance suggests an increased risk of a particular serious neurological condition called Guillain-Barré syndrome within 42 days of receiving the Janssen COVID19 vaccine.
“Mix and Match” Booster Dose Approval
Today, the FDA also approves the use of heterogeneous (or mixed and matched) booster doses for the currently available (ie, FDA-approved or approved) COVID-19 vaccine. After presenting clinical trial data from the National Institute of Infectious Diseases, discussing the Vaccine and Related Bioforms Advisory Committee on the information submitted for review, and evaluating the available data by the authorities, the FDA is known. The benefits of using a single heterologous booster dose, which we have determined to be possible, outweigh the known potential risks of using it in a qualified population.
A single booster dose of any of the available COVID19 vaccines can be given as a heterologous booster dose after completing the first vaccination with another available COVID19 vaccine. Appropriate populations and dosing intervals for heterologous booster doses are the same as those approved for booster doses of vaccines used for primary vaccination.
Moderna Booster Update: For example, Janssen COVID19 vaccinated persons over the age of 18 can receive the Janssen COVID19 vaccine, Moderna COVID19 vaccine (half dose), or Physerbio N-Tech COVID19 vaccine at least two months after obtaining the basic Janssen COVID19 vaccine, You can receive a single booster vaccination.
In another example, recipients of the Moderna COVID19 and Pfizer BioNTech COVID19 vaccines fall into one of the approved booster immunization categories (65 years and older, 18-64 years at high risk of severe COVID19, and to SARSCoV2). General institutional or occupational exposure can be vaccinated with booster doses of Moderna COVID19 vaccine (half dose), PfizerBioNTech COVID19 vaccine or Janssen COVID19 vaccine for at least 6 months after the completion of primary vaccination.
We are aware that COVID19 vaccinated people will ask about booster immunization. A separate fact sheet for each vaccine available contains information related to health care providers and vaccinated people. It also encourages healthcare providers to follow the CDC recommendations that come after the Vaccination Implementation Advisory Board meeting and the formal recommendations signed by the CDC Director.