According to the most recent stats from Our World in Data, more than 390 million COVID-19 vaccine doses have been administered worldwide, with over 231.5 million people having received at least one jab. The stats include all the vaccine candidates that have been authorized for emergency use in various regions and they are quite promising. As vaccine supply increases, more people get access to coronavirus vaccines, with vaccination campaigns slowly expanding to more categories of people.
There is one large group of people who won’t get access to vaccines anytime soon, but thankfully, it’s also the category that’s the least likely to experience a severe infection. Children under 16 or 18 years of age aren’t eligible for any vaccines, as the drugs have not been tested on this population category. Several of the leading COVID-19 vaccine manufacturers are already expanding tests to children and teens. Among them, Moderna is the first to include babies and young children in the new research.
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Moderna announced a few days ago that it started new trails for updated COVID-19 vaccine versions that should be more effective against the South African mutation. This coronavirus variant has shown that it can evade antibodies, so it can reinfect COVID-19 survivors and reduce the efficacy of current vaccines.
On Tuesday, Moderna revealed the brand new coronavirus vaccine Phase 2/3 trial that seeks to determine the drug’s effectiveness and safety in volunteers aged from six months to 12 years — the KidCOVE study.
Moderna will seek to include 6,750 participants from the US and Canada in the trial, and the company will use the same mRNA-1273 drug that’s currently administered to adults ages 18 and above. Doses will still be administered 28 days apart. The dosage will vary, however, as babies and young children will receive lower doses than adults.
The study will have two parts. In the first one, children under 2 years will receive two shots of either 25, 50, or 100 micrograms. Those between 2 and 12 years old will get doses of 50 or 100 micrograms. Adults currently receive two 100-microgram jabs 28 days apart. The first volunteers will be given the lower doses first and then observed for side-effects. Volunteers joining later will get higher doses. An interim analysis will determine the most appropriate dosage regimen for the various age groups.
The second part will include a different group of volunteers who will receive the doses according to conclusions from the first part. Like the studies covering the adult population, this part of the study will be randomized and placebo-controlled, meaning that each group of children will have a control group that will only receive a saline solution.
Participants will then be followed 12 months after the second jab. Vaccine efficacy will be inferred through antibody comparisons with young adults between 18-25 who are eligible for the complete vaccination program, but researchers will also look for signs of infection. The study will monitor for side effects in this age group.
Moderna is the first to include babies and young children in its vaccine trials. The company also has a different trial in place that includes 3,000 children ages 12 to 17. Results for that group will be ready by summer, The New York Times reports.
All the other companies who have received Emergency Use Authorization for their vaccine candidates are also working on vaccines for children. AstraZeneca and Oxford began testing the vaccine in Britain in children 6 years and older. Johnson & Johnson plans to test vaccines in babies and young children after testing the drug in older children. Pfizer and BioNTech are studying their drug in children ages 12 to 15, and younger groups will follow. The Pfizer drug is currently available to people over 16.
Separately, doctors have already encountered cases of babies born with coronavirus antibodies in women who caught COVID-19 during pregnancy. Similarly, a Florida woman just gave birth to the first known baby with coronavirus antibodies following vaccination. The woman is a healthcare worker who received her first Moderna dose in January when she was 36 weeks pregnant.
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