Novavax announced on Friday, 11 February, that their COVID-19 vaccine showed 80 percent effectiveness in preventing symptomatic illness in children between the ages of 12 and 17, in late stage clinical trials.
If cleared by regulators, it Novavax could become the first protein based COVID vaccine for kids under 18 to be rolled out in the US.
The company also said that the Phase 3 clinical trial results showed no significant side effects of the vaccine in this age group.
Novavax took to Twitter on 11 February to break down the findings of the study.
What do we know about Novavax's COVID-19 vaccine for kids? What does it mean for kids in India? FIT breaks it down.
Study Highlights
The phase 3 study was a randomised, observer-blinded, placebo-controlled, crossover trial.
It was conducted between May and September in 2021 when Delta was the dominant variant in the US.
The trial involved, 2247 adolescent participants between the ages of 12 and 17
Of these, 1500 participants were given two doses of Novavax with a gap of 25 days between both doses
The remaining 750 participants were given placebo.
Nearly 50 percent of the participants in the vaccine arm were females.
Although the study also involved people of other races, nearly 80 percent of the participants in the vaccine arm were white.
The participants of each arm were then given 2 doses of the placebo and 2 doses of the vaccine, respectively.
Phase 3 Clinical trials of Novavax on 12 to 17 year olds.
(Source: Twitter/ @Novavax)
Key findings of the study:
According to Novavax, their vaccine is 82 percent effective in preventing symptomatic COVID illness, which was found to be consistent across all ages.
Neutralising antibody response was found to be 1.5 times higher in this age group than in participants in the Phase 3 trials conducted in adults in the US.
"Overall, adolescent antibody titers were higher than in adults. Titers were higher in younger than in older adolescents."Novavax via Twitter
No remarkable side effects were noticed in the teens as compared to the adults, added the company.
The most common side effect according to their statement was local pain and tenderness.
The study also found that post vaccine symptoms of fever, fatigue, and joint pain among others were more severe after the second dose in adolescents.
The results of the study were also consistent across age groups, sex, and race within this trial as well.
How It Works
Type of vaccine: Covovax is a protein subunit vaccine that targets the spike protein of the COVID virus to help the body develop immunity against the virus. It is produced by creating an engineered baculovirus containing a gene for a modified SARS-CoV-2 spike protein.
Dosage: It is a two-dose vaccine, just like Serum Institute of India's Covishield and Bharat Biotech's Covaxin.
What Does This Mean for Teens in India?
In India, Novavax's COVID vaccine is being manufactured by Pune based Serum Institute of India, under the brand name of Covovax.
On 25 December, it was announced that Covovax has been granted Emergancy Use Authorisation (EUA) by India's drug regulatory body Central Drugs Standard Control Organisation (CDSCO).
Covovax was also granted approval to include children between the ages of 7 to 11 and 12 to 17 in clinical trials in India. The results of the study are yet to be published.
However, the encouraging data from the trials results conducted in the US could help accelerate the process, especially if the vaccine is granted authorisation by the US drugs regulatory bodies.
COVID vaccine for children in India:
So far, India has approved two COVID vaccines for kids below the age of 18— Covaxin, and ZyCoV-D (Zydus Cadila).
However, at the moment, only the Covaxin COVID vaccine has been rolled out for children, and has been restricted to kids between 15 and 18 years of age.
(At The Quint, we question everything. Play an active role in shaping our journalism by becoming a member today.)