The Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) are continuing to make changes in COVID-19 vaccine availability as more data comes in from research centers.
Tuesday evening, November 2, Dr. Rochelle Walensky, Director of the CDC endorsed the unanimous recommendation of the CDC Advisory Committee on Immunization Practices to vaccinate children ages five to 11 against COVID-19. This is the latest addition to the list of those eligible for vaccination. In preparation for the approval, the vaccine has already been shipped to many outlets, including pediatrician’s offices and state health departments.
The FDA had approved emergency use of the Pfizer/BioN-Tech vaccine for those between the ages of five and 11 last week, turning the final ruling over to the CDC.
Just recently the CDC approved both Moderna and Johnson and Johnson/Janssen boosters for those over 65, those 18 to 64 who are immunocompromised, and those 18 to 65 who are more likely to be exposed to the disease because of institutionalization or an occupation. They have also approved the ability to “mix and match” the vaccines.
Approval of Vaccinating Children Five to 11 Years of Age
United States Surgeon General Dr. Vivek Murthy was recently interviewed by CNN about the approval of the use of Pfizer COVID-19 vaccine for children between the ages of five and 11 years of age. As a parent himself, he sees children’s health and safety coming first.
“Parents across the country have been waiting for a vaccine for a long time,” said Dr. Murthy, “and are eager that this moment might be close.”
While some parents are asking many questions before taking their children to get vaccinated, Dr. Murthy notes that COVID-19 has “not been benign with children, even if they do better than older adults.”
With the Delta variant, 25% of patients have been children. Hundreds have lost their lives, and thousands have been hospitalized according to Murthy. According to an article in the Washington Post, the number of cases of COVID-19 in children surpassed adults in August of 2021.
COVID-19 initially hit children with less of a punch than the Delta variant. Dr. Murthy stated that more children are suffering from long COVID, which brings fatigue, shortness of breath, and chest pain. Doctors are also seeing more children with heart disease created by the inflammation caused by the disease.
Pfizer will be providing the initial vaccination to children between five and 11 once approved. The dosage will be a third of that given to adults. Children’s dosages will be color coded orange, and adult doses are color coded purple to make sure that there is no question about the appropriate dosages.
“We want to protect our kids,” said Dr. Murthy, “We want them to get their lives back.”
COVID-19 Vaccine Booster Options
According to the FDA, the booster dose of the Johnson and Johnson COVID-19 vaccine may be administered at least two months after completion of the single-dose primary regimen to individuals 18 years of age and older. For Moderna, like the previously approved Pfizer booster, administration of the single-dose booster can be administered at least six months after the initial two-dose series to approved populations.
The CDC has also approved the opportunity to “mix and match” booster doses following the completion of primary vaccination(s). Johnson and Johnson COVID-19 vaccine recipients 18 years of age and older may receive a single booster dose of Johnson and Johnson COVID-19 vaccine, a half dose of Moderna or a full dose of Pfizer at least two months after receiving their initial Johnson and Johnson COVID-19 vaccination. Moderna and Pfizer COVID-19 vaccine recipients falling into one of the authorized populations for boosters may receive a booster half dose of Moderna, a full dose of Pfizer or a full dose of the Johnson and Johnson COVID-19 vaccine at least six months after completing their primary vaccination(s).
“…[S]cience has shown that vaccination continues to be the safest and most effective way to prevent COVID-19, including the most serious consequences of the disease, such as hospitalization and death,” said Acting FDA Commissioner Janet Woodcock, M.D. “As the pandemic continues to impact the country, the available data suggest waning immunity in some populations who are fully vaccinated. The availability of these authorized boosters is important for continued protection against COVID-19 disease.”
Risks Associated with COVID-19 Vaccines
“The amendments to the emergency use authorizations to include a single booster dose in eligible populations are based on the available data and information and follows the input from the members of our advisory committee who were supportive of the use of a booster dose of these vaccines in eligible populations,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research.
As part of the approval research, safety of the vaccines was evaluated. The research found that the most common side effects were pain at the injection site, tiredness, headache, muscle and/or joint pain, chills, nausea and vomiting, and fever. Swollen lymph nodes in the underarm were also observed, but they were more frequently found following the booster dose than after the primary two-dose series.
Moderna vaccine, especially the second dose, has been found to increase the risk of the inflammatory heart conditions myocarditis and pericarditis. The highest incidence of this condition has been observed in males under 40, especially those between the ages of 18 and 24. The condition is usually mild and easily treatable. It manifests in about 40 out of one million cases.
Thrombocytopenia syndrome (TTS) can be caused by the Johnson and Johnson vaccine. This is a rare and serious blood clot in combination with low blood platelets. Symptoms usually begin about one or two weeks after vaccination. A risk of developing Guillain Barré Syndrome, a serious neurological disorder, has also been found with the Johnson and Johnson vaccine. The syndrome manifests within 42 days following receipt of the vaccine.
Clinical trials by the National Institute of Allergy and Infectious Disease and the Vaccine and Related Biological Products Advisory Committee determined that the benefits of the three vaccines far outweighs the potential risks.
As doctors state when asked, no vaccine is infallible, but they are the most powerful layer of protection that we have against COVID-19, including the Delta variant. There is no silver bullet, but the vaccine combined with the use of handwashing and masks when in public spaces will increase personal safety against the disease.