This was announced by a US biotechnology company based on the results of clinical research on the anti-Covid vaccine for this age group. It is expected to apply for authorization from the FDA and other regulatory agencies around the world in early June.
Moderna’s Covid vaccine is very effective in adolescents, which greatly exceeds the immune response of adults. This was announced by the American biotechnology company in a statement that conveyed the first batch of data from the TeenCOVE clinical study, which recruited 3,700 boys between the ages of 12 and 18. “After two doses -Indicates company- 100% efficacy observed From 14 days after the second administration“.
Moderna Youth Vaccine
In the trial, the teenagers were divided into two groups (in a 2:1 ratio) and received two doses of serum mRNA (mRNA-1273) or placebo. “Main endogenous -Designated company- In the phase 3 adult study, it was not inferior to the comparison group. After two doses, No Covid-19 cases were observed in the vaccination group, And 4 cases in the placebo group“.
In addition, preliminary data indicate that after a single dose of administration, 93% of protection against any form of symptomatic disease can be obtained starting from 14 days after administration. As for safety, the vaccine”It is well tolerated“No serious adverse events were reported.”Most side effects are mild or moderate.The most common local adverse events are Pain at the injection site, And the most common systemic effect after the second dose is Headache, fatigue, myalgia and chills“.
Clinical trial results will be submitted Publish in a peer-reviewed journal,Continue to accumulate and supervise the research by an independent safety committee. The conclusion is that the company will follow up the study participants for 12 months after the second injection,Assess long-term safety“.
Authorization request in early June
The company plans to submit data to global regulators At the beginning of June After obtaining approval from the U.S. Food and Drug Administration (FDA) and health agencies in Canada, Israel, the European Union, and the United Kingdom for people aged 18 and over, apply for authorization to use the vaccine in that age group, Switzerland, Singapore, Qatar, Taiwan , Philippines, Thailand, Brunei, Paraguay, Japan, South Korea and the World Health Organization (WHO) Emergency Use List (EUL).
“We are encouraged by the fact that the mRna-1273 vaccine is very effective in preventing Covid-19 in adolescents-this is emphasized by Moderna’s CEO Stéphane Bancel. It is particularly exciting to see that the Moderna Covid-19 vaccine can prevent Sars-CoV-2 infection”, He observed, confirmed the promise”Do our best to help end the pandemic“.