Once again, regulators are having concerns about the safety of the Moderna COVID jab, particularly among young patients, following data released over the summer which suggested that the Moderna jab might be even more dangerous to younger patients than its top rival, the Pfizer jab. Safety studies on both vaccines carried out by Canadian researchers found that the Moderna jab might be as much as 2.5x higher than the dangers of side effects from the Moderna jab.
After the FDA and CDC ignored the advice from their respective advisory panels and went ahead with offering emergency use approvals for both jabs and the J&J jab for younger patients, But now, the FDA is re-examining its decision to authorize the Moderna COVID jab for adolescents as young as 12 years old. Specifically, the agency is examining the potentiality for dangerous heart inflammation in a certain group of younger patients, who are at a higher risk of side effects.
The FDA has decided to delay its approval for the Moderna jab for patients between the ages of 12 to 17 - a decision that comes just three days after the FDA authorized the Pfizer-BioNTech's COVID-19 vaccine or children between ages five and 11.
It also comes just before Moderna's advisors were expected to expand emergency use of the vaccine to the youngest patients as well.
According to the Hill, Moderna, based in Cambridge, Massachusetts, was told the federal agency would need until at least January 2022 before the FDA can finish its review. The company also added that it will delay its request for FDA authorization of its COVID vaccine for children 6 to 11 years old, the paper reported.
The agency informed Moderna on Friday night that it would require the extra time to further examine ongoing and emerging data - from international sources - on the risks of myocarditis, which is an inflammation of the heart muscle that in rare cases occurs after vaccination.
The announcement comes after several countries including Finland and other from Nordic nations to Japan, voiced concerns that the Moderna vaccine increased the risk of myocarditis in men ages 18 to 30.
Moderna says FDA told co it needs “additional time to evaluate recent international analyses of the risk of myocarditis after vaccination,” review of #covid19 vaccine for age 12-17 may take until Jan 2022. Moderna will delay filing for 6-11 as a result https://t.co/7UBeeQOtI7— Meg Tirrell (@megtirrell) October 31, 2021
In June, Moderna requested the FDA to authorize its vaccine for adolescents, with the shot having been approved previously for people 18 and older. The proposed vaccine treatment protocol for teens would be the same as that for adults, with two 100-microgram shots received 28-days apart. Moderna's proposed vaccination for children 6 to 11 years old that is now on hold would have been for them to receive two half-dose shots of 50 micrograms, the Post reported.
In its statement, Moderna said 'the safety of vaccine recipients is of paramount importance' and that it's working closely with the FDA.
Per the press release, many adults aren't particularly eager to vaccinate young kids since the kids aren't seen as particularly vulnerable.
To be sure this is just a hiccup. It's no more than a disruption. Still, child-size vials that can be kept in refrigerators along with smaller needles necessary for injecting young kids will be sent to providers across the country.
The youngest patients will be able to receive the shot at their pediatrician's offices or local pharmacies, and potentially even their schools rather than mass immunization sites.
Moderna shares were off nearly 3% on the news.
Read the full press release below:
Moderna, Inc. (Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today provided an update that the U.S. Food and Drug Administration (FDA) has notified the Company that it will require additional time to complete its assessment of Moderna’s Emergency Use Authorization (EUA) request for the use of the Moderna COVID-19 vaccine (mRNA-1273) at the 100 µg dose level in adolescents 12 to 17 years of age.
On Friday evening, the FDA informed Moderna that the agency requires additional time to evaluate recent international analyses of the risk of myocarditis after vaccination. The FDA notified Moderna that this review may not be completed before January 2022. The safety of vaccine recipients is of paramount importance to Moderna. The Company is fully committed to working closely with the FDA to support their review and is grateful to the FDA for their diligence.
An increased risk of myocarditis has been described for COVID-19 vaccines, including the Moderna COVID-19 vaccine, particularly in young men and following the second dose. The U.S. Centers for Disease Control and Prevention (CDC) and the World Health Organization (WHO) have stated that myocarditis following vaccination with mRNA vaccines has been rare and generally mild.
It is estimated that over 1.5 million adolescents have received the Moderna COVID-19 vaccine. To date, the observed rate of myocarditis reports in those less than 18 years of age in Moderna’s global safety database does not suggest an increased risk of myocarditis in this population. Moderna is committed to conducting its own careful review of new external analyses as they become available. The Company does not yet have access to data from some recent international analyses.
Moderna will delay filing a request for EUA of mRNA-1273 at the 50 µg dose level in the pediatric population (6-11 years of age) while the FDA completes its review of the adolescent EUA request.