By Emily Mangiaracina
An FDA advisory panel voted overwhelmingly today to recommend emergency use authorization (EUA) of Moderna’s mRNA 1273 COVID-19 vaccine, with 20 members in favor, and none officially opposing the opinion that the vaccine’s benefits “outweigh its risks for use in individuals 18 years of age and older.”
Only one panel member, Michael Kurrilla, abstained from voting. He explained his decision at the conclusion of the vote, saying, “I’m very uncomfortable with the language. I think in the midst of a pandemic and with limited vaccine supply available, a blanket statement for individuals 18 years of age and older is just too broad.”
“I’m not convinced that for all of those age groups the benefits do actually outweigh the risks, and I would prefer to see it more targeted towards people at high risk of serious and life-threatening (COVID) disease.”
He continued, “I would have preferred to have seen rather than an emergency use authorization route, an expanded access program; I think it would’ve given us a lot more opportunities to continue to collect the data.”
Panel member Sheldon Toubman added that he was strongly in favor of a priority-based sequence of distribution rather than an immediate, all-encompassing rollout of the vaccine.
“I’m very concerned about Moderna’s proposal … it seemed like there was strong support for, if they’re going to unwind, they should do it on the basis of when it comes up in its priority, and not everybody right away, which is what Moderna has proposed. I think that would be really a disservice,” said Toubman.
The Moderna vaccine shares much in common with the Pfizer vaccine, including the involvement of fetal tissue in its testing.
Human Embryonic Kidney (HEK) 293 aborted fetal cells were used to produce a Spike protein contained in the Moderna vaccine, according to Debi Vinnedge, executive director of Children of God for Life, an organization that fights to end the use of aborted fetal material in vaccines and medicines.
The Spike protein is involved in the Moderna vaccine’s mRNA technology, which is also used by the Pfizer vaccine. The mRNA, a type of RNA “that carries genetic information to make proteins in a cell,” causes our cells to manufacture their own viral particles that will trigger our immune defense response.
We cannot know whether RNA will integrate into our own genome because there are enzymes that turn RNA into DNA, such as in HIV carriers, according to Dr. Louis Fouché, a specialist who works in a major Marseille hospital.
The Moderna vaccine, like the Pfizer vaccine, requires two shots, and is also reported to share similar side effects. The Moderna vaccine has caused pain at the injection site in more than 9 in 10 participants, fatigue in almost 7 in 10, and headaches or muscle pain in about 6 in 10, according to the FDA.
“More than 44 percent of people who received the vaccine reported experiencing joint pain and over 43 percent reported chills,” reported CNBC.
However, up to almost 10 percent of participants experienced “serious adverse reactions,” which included intractable nausea and vomiting, facial swelling and rheumatoid arthritis.
“The FDA noted that more severe “serious adverse reactions occurred in 0.2 percent to 9.7 percent of participants” and were more common after the second dose than the first,” CNBC continued.
It should be noted that neither vaccine trials for the Moderna vaccine nor for the Pfizer vaccine were conducted with pregnant women or immunocompromised individuals.
The major difference between the two vaccines is that the Moderna vaccine can be stored at more practical temperatures – around −4°F -– while the Pfizer vaccine must be stored at −94°F, ABC News reported.