By Lehlohonolo Lehana.
Moderna Inc’s Covid-19 vaccine was highly effective in 12 to 17 year-old adolescents in a large study, paving the way for regulatory submissions around the world by early June.
In a news release, the company said its vaccine was between 93% and 100% effective in preventing symptomatic Covid in a study of teenagers, depending on whether very mild cases are included in the count.
The study met its primary goal of showing that immune responses to the vaccine in 12 to 17 year-olds were as good as those produced in adults, and no significant safety concerns were observed, according to the company.
The results put Moderna’s vaccine, currently authorized in the US for people 18 and up, on track to soon become the second shot authorized in the US for younger teens. Earlier this month, the US Food and Drug Administration expanded clearance of the Pfizer Inc.-BioNTech SE vaccine to include teenagers ages 12 to 15.
That vaccine was originally authorized for those 16 and up.
“We will submit these results to the U.S. FDA and regulators globally in early June and request authorization,”
If Moderna’s vaccine gains clearance for teens it could help broaden the US immunization campaign. However, there have been signs that overall demand for shots across the country has peaked.
As of Monday, about 1.8 million doses a day were being administered in the US, down from more than 3 million a day on average in mid-April.
Moderna chief executive officer Stephane Bancel said in a statement.
The company’s shares rose as much as 3.8% in pre-market trading.
In Moderna’s study of 3,732 adolescents, its vaccine was 100% effective starting 14 days after receiving the second dose, based on the same strict definition of Covid-19 that was used to assess the vaccine in a final-stage adult trial.
There were no cases of Covid-19 in kids who got the vaccine compared with 4 cases in the smaller group of teens who received a placebo.
Using a broader case definition that includes milder cases with just one symptom and a positive test result, the vaccine was 93% effective starting 14 days after the first dose, Moderna said.
The new findings are consistent with data from the same study released by Moderna earlier this month. That data found the vaccine was 96% effective starting 14 days after the first dose.
In the study, Moderna said common side effects included injection- site pain, headache, fever, muscle pains, and chills. The company said it planned to submit the data for publication in a scientific journal.
Meanwhile the number of new Covid-19 cases is on the rise in all provinces in South Africa, the health ministry said on Tuesday night.
In the past 24 hours, 3,084 new infections had been recorded at a positivity rate of 11%, taking the cumulative number of cases to date to 1,640,932.
“There are currently 41,005 active cases in the country, reflecting a 0.69% increase inactive cases over the past 24 hours. The Northern Cape currently has the active cases per 100,000 population at 622.1, followed by the Free State at 232.7, the North West at 118.7, Gauteng at 74.0 and the Western Cape at 43.9 active cases per 100,000 population
“Nationally, there has been a 17% increase in new cases compared to 7 days prior. All provinces continue to show increases in new cases compared to 7 days prior.
“As of May 25, 2021, the highest case incidence per 100,000 population over the past 7 days was reported in the Northern Cape at 226.9, followed by the Free State at 101.2, Gauteng at 58.4, the North West at 52.7, Mpumalanga at 24.4, and the Western Cape at 22.8 new cases per 100,000 population,” said minister Dr Zweli Mkhize.
The minister also announced that 102 new Covid-19 cases had been confirmed in the past 24 hours. Of these, 26 deaths “occurred in the past 48 hours”. There have been 55,976 cumulative deaths recorded across SA since the outbreak of the virus in March last year.
When it came to vaccinations, Mkhize said that 47,046 received the first dose of their Pfizer vaccine as of midnight on May 24, meaning that there had now been 221,136 Pfizer jabs administered across SA. Combining this with the 479,768 Johnson & Johnson vaccinations administered under the Sisonke programme, it means that 700,904 people have now received at least one dose under the vaccine rollout.