Drug maker Moderna said Wednesday that it would soon start testing its coronavirus vaccine in children ages 12-17. The studyListed on Wednesday’s clinicaltrials.gov website, is believed to include 3,000 children, half of whom will receive two vaccinations four weeks apart and the other half will receive placebo salt water.
However, the publication states that the study has “not yet been recruited,” and Colleen Hussey, a spokeswoman for Moderna, said it was not certain when the test sites would be listed or volunteers would be enrolled. A link to testing centers on the website isn’t working yet and Ms. Hussey said she wasn’t sure when he would act.
Moderna announced on Monday These data, from his study of 30,000 adults, found the vaccine to be 94.1 percent effective and that he had applied for an emergency permit from the Food and Drug Administration to start vaccinating adults. If approved, certain groups of high-risk adults, including people in nursing homes, could receive gunshots in late December.
But no vaccine can be widely given to children until it has been tested in them. Vaccines intended for both adults and children are generally tested in adults first to make sure they are safe for pediatric studies.
Moderna’s vaccine has not yet been studied in children or pregnant women. In the new clinical trial in adolescents, girls after puberty are tested before each injection to make sure they are not pregnant.
“Everyone expects the Covid vaccine will work if we test this in teenagers first, then older children, and then real young children,” said Dr. William Schaffner, Vanderbilt University infectious disease specialist and vaccine advisor for the Centers for Disease Control and Prevention.
But children have more active immune systems than adults and can have stronger reactions, including more fever, muscle and joint pain, and fatigue, said Dr. Conductor.
“They can be more out of line than adults for a day or two,” he said. “You really want to know what parents can expect when it is given to teenagers? You really want to be able to tell them clearly how you might be feeling 24 or 48 hours after receiving the vaccine. And of course, we really want to be able to tell parents, that it works. “
If a child experienced severe side effects and parents weren’t prepared for them, they might be reluctant to go back to the second shot, said Dr. Conductor.
Dr. Paul A. Offit, a vaccines expert at Philadelphia Children’s Hospital, said vaccines “for the most part” work equally well in children and adults. Occasionally, like the hepatitis B vaccine, different doses are required, he said. Moderna will study the same dose in children that it tested in adults.
Confused by all of the technical terms used to describe how vaccines work and study? Let us help:
- Adverse event: A health problem that occurs in volunteers in a clinical trial with a vaccine or drug. An adverse event is not always caused by the treatment tested in the study.
- Antibody: A protein produced by the immune system that can attach to a pathogen such as the coronavirus and prevent it from infecting cells.
- Approval, Licensing, and Approval for Emergency Use: Medicines, vaccines and medical devices cannot be sold in the US for no profit approval by the Food and Drug Administration, also known as Licensing. After a company has submitted the results of clinical studies to the F.D.A. For testing purposes, the agency decides whether the product is safe and effective. This process usually takes many months. If the country faces an emergency – like a pandemic – a company can file an application instead Emergency approvalthat can be granted much faster.
- Background rate: How often does the general population experience a health problem called an Adverse Event? To determine whether a vaccine or drug is safe, researchers compare the rate of adverse events in one study to the background rate.
- Effectiveness: A measure of the effectiveness of a treatment in a clinical trial. To test a coronavirus vaccineFor example, researchers compare how many people in the vaccinated group and the placebo group received Covid-19. The actual effectiveness of a vaccine may differ from its effectiveness in a study.
- Phases 1, 2 and 3 studies: Clinical trials typically take place in three phases. Phase 1 studies typically involve a few dozen people to determine whether a vaccine or drug is safe. In Phase 2 trials involving hundreds of people, researchers can try different doses and take more measurements of the vaccine’s effects on the immune system. Phase 3 studies involving thousands or tens of thousands of volunteers determine the safety and effectiveness of the vaccine or medicine by waiting to see how many people are protected from the disease it is supposed to be fighting.
- Placebo: A substance with no therapeutic effect that is widely used in clinical trials. For example, to see if a vaccine can prevent Covid-19, researchers can inject the vaccine into half of their volunteers while the other half are given a placebo with salt water. You can then compare how many people are infected in each group.
- Post-market surveillance: The surveillance that occurs after a vaccine or drug has been approved and regularly prescribed by doctors. This monitoring usually confirms that the treatment is safe. Rarely, side effects are noted in certain groups of people that were overlooked during clinical trials.
- Preclinical Research: Studies that take place prior to the start of a clinical trial typically include experiments that test a treatment on cells or animals.
- Viral vector vaccines: A type of vaccine that uses a harmless virus to deliver immune-stimulating ingredients into the human body. Viral vectors are used in several experimental Covid-19 vaccines, including that of AstraZeneca and Johnson & Johnson. Both companies use a cold virus called adenovirus as a vector. The adenovirus carries coronavirus genes.
- Test protocol: A series of procedures that must be performed during a clinical trial.
Pfizer began testing its coronavirus vaccine in children 12 years and older in October. A large clinical study found that the vaccine is 95 percent effective in adultsand the company has an emergency clearance from the F.D.A. Britain approved the Pfizer vaccine for adults on Wednesday, the first country to do this.
AstraZeneca has also tested its vaccine in children, but not in the US.
As vaccine studies have progressed, Rumors have spread on social media, especially among people speaking out against vaccines In general, President-elect Joseph R. Biden Jr. plans to require vaccination for everyone, including children. His team has denied these claims, and Mr Biden has stated that he will rely on the advice of scientists to best end the pandemic.