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Legislation Proposed For Children To Get Vaccine At Pharmacy

As federal regulators and drug makers work on a COVID-19 vaccine for children, a state legislator wants to be ready to widely administer that vaccine.

S.7320 would not require a COVID-19 vaccination for children. It is similar to a bill (S.8182A/A.10508A) passed in 2020 allowing pharmacists to administer an FDA-approved COVID-19 vaccine to adults.

“Pharmacist-administered vaccinations have been a key component of New York’s vaccine distribution plan, particularly in neighborhoods and parts of the state where pharmacies are a primary health care option,” wrote Sen. Brad Hoylman, D-New York City, in his legislative justification. “This legislation would expand pharmacists’ ability to administer COVID-19 vaccines to children as young as 2 years old once the FDA has authorized the vaccine for that age cohort.”

Moderna officials said in late July the company expects to have enough data to apply for FDA authorization in younger children by late 2021 or early 2022. Pfizer has previously said it expects to apply in September for children ages 5 through 11. Results for two younger age groups that began testing a little later should be available by October or November, according to the company.

Last week, the American Academy of Pediatrics sent a letter to the Food and Drug Administration asking the federal agency to continue working aggressively on a vaccine for children. COVID-19 vaccine trials for adults followed adults who received the vaccine for two months to see if there were side effects. The FDA has requested the companies working on vaccines for children to follow the children for four to six months.

In July, Moderna announced it is expanding its COVID-19 childhood vaccine study to better detect rare side effects that had been flagged by the FDA. The company had intended to test the vaccine in roughly 7,000 children. Pfizer officials said in July that the company is also making changes to its vaccine testing in children as it tests its vaccine in up to 4,500 children in the United States and Europe.

“Pediatricians and the families they care for have been anxiously awaiting a vaccine that can be used in children 11 years of age and younger, and especially so now given the rise of the hyper infectious Delta variant,” wrote Dr. Lee Savio Beers, association president. “The Delta variant is surging at extremely alarming rates in every region of America. This surge is seriously impacting all populations, including children.”

The Pediatrics Association said the last week of July saw the largest week-over-week percentage increase in pediatric COVID-19 cases since the start of the pandemic. The data show 71,726 COVID cases in children reported that week, almost double the 38,654 reported in the previous week. The stark increase in cases prompted the letter to the FDA, which is reviewing cases of a rare type of heart inflammation called myocarditis that has been reported in a small number of teenagers who got the Moderna or Pfizer shots.

Beers’ letter states American Academy of Pediatrics members believe the vaccine trials could be conducted in a two-month safety follow-up for participants rather than four to six months.

“Waiting on a 6-month follow-up will significantly hinder the ability to reduce the spread of the hyper infectious COVID-19 Delta variant among this age group, since it would add 4 additional months before an authorization decision can be considered,” she wrote. “Based on the evidence from the over 340 million doses of COVID-19 doses administered to adults and adolescents aged 12-17,as well as among adults 18 and older, there is no biological plausibility for serious adverse immunological or inflammatory events to occur more than two months after COVID-19 vaccine administration. While there is justifiable concern about reported cases of myocarditis in younger adults and adolescents receiving a mRNA COVID-19 vaccine, these events are extremely rare, and, if they were to occur, they would most likely happen within four weeks of receiving the vaccine. In even rarer cases this might present at six weeks, but not longer. In addition, data on the severity of reinfections of COVID-19 do not seem to prime a more adverse immunological response, which lessens the concern that there would be a late negative adverse effect of COVID vaccination.”

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