Today, 31 January 2022, the Moderna COVID-19 vaccine, with the outstanding name of Spikevax, was approved in the USA by the FDA. Spikevax, which went by the name of mRNA-1273 during clinical trials, had been approved under an Emergency Use Authorization (EUA) since late 2020. This will be the second COVID-19 vaccine approved by the FDA after Pfizer‘s Cominarty vaccine received FDA approval on 23 August 2021.
This short post (for me, at least) will review the salient points about the FDA approval for Spikevax. And I hope whatever marketing geek at Moderna who came up with that name gets a big bonus check and promotion.
Spikevax FDA approval information
The FDA said Spikevax “meets the FDA’s rigorous standards for safety, effectiveness and manufacturing quality required for approval.”
Acting FDA Commissioner, Janet Woodcock, MD, stated that:
The FDA’s approval of Spikevax is a significant step in the fight against the COVID-19 pandemic, marking the second vaccine approved to prevent COVID-19. The public can be assured that Spikevax meets the FDA’s high standards for safety, effectiveness and manufacturing quality required of any vaccine approved for use in the United States. While hundreds of millions of doses of Moderna COVID-19 Vaccine have been administered to individuals under emergency use authorization, we understand that for some individuals, FDA approval of this vaccine may instill additional confidence in making the decision to get vaccinated.
Here are some key points regarding the FDA approval of Spikevax:
- Spikevax will have the same exact formulation as the Moderna mRNA-1273 vaccine that was approved for the EUA. There are no differences at all.
- Spikevax and remaining stocks of mRNA-1273 can be used interchangeably. There are no differences (just to repeat it so everyone understands).
- It still requires two doses about one month apart.
- It is approved for individuals 18 years and older.
- It is approved as third dose for individuals 18 years of age and older who have certain conditions that can compromise the immune system.
- It is approved for a single booster dose for individuals 18 years of age and older at least five months after completing the primary two doses.
- It is also authorized for use as a heterologous single booster dose for individuals 18 years and older following completion of primary vaccination with a different COVID-19 vaccine.
- Other age groups and booster recommendations that were approved under EUA’s still remain in force.
According to the FDA:
The updated analyses to determine effectiveness of Spikevax included 14,287 vaccine recipients and 14,164 placebo recipients 18 years of age and older who did not have evidence of SARS-CoV-2 infection prior to receiving the first dose. The data used for the analyses were accrued before the Omicron variant emerged. These data demonstrated that Spikevax was 93% effective in preventing COVID-19, with 55 cases of COVID-19 occurring in the vaccine group and 744 COVID-19 cases in the placebo group. The vaccine was also 98% effective in preventing severe disease.
The FDA’s safety analysis of Spikevax included approximately 15,184 vaccine recipients and 15,162 placebo recipients 18 years of age and older, more than half of these participants were followed for safety outcomes for at least four months after the second dose. Approximately 7,500 participants originally assigned to receive Spikevax in the blinded phase of the clinical trial completed safety follow-up for at least 6 months after the second dose.
The most commonly reported side effects by clinical trial participants were pain, redness and swelling at the injection site, fatigue, headache, muscle or joint pain, chills, nausea/vomiting, swollen lymph nodes under the arm and fever.
The FDA also rigorously examined reports of myocarditis (inflammation of heart muscle) and pericarditis (inflammation of the tissues around the heart) after mRNA vaccinations. They found that the data demonstrated slightly increased risks, particularly within seven days following the second dose. Males 18 through 24 years of age were at the highest risk. However, an examination of available data suggested that the conditions were temporary and individuals had a quick resolution of symptoms.
The FDA is requiring post-marketing surveillance and studies to “further assess the risks of myocarditis and pericarditis following vaccination with Spikevax. These studies will include an evaluation of long-term outcomes among individuals who develop myocarditis following vaccination with Spikevax.” Moderna has been performing these studies before the FDA required them.
Now that Spikevax has been fully FDA approved for 18-year-olds, that should eliminate one of the more ridiculous tropes about any vaccine that was approved under the EUA — it’s an “experimental” vaccine. Even though they were only “experimental” during the clinical trial, at least with full FDA approval you can get the same vaccine except with a cool name.
Although the FDA approval is for 18-year-olds, the old EUA still applies for individuals under that age. They can still get Spikevax and tell their friends about it.
This is more good news as we try to increase the number of people who can get vaccinated.
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