Epidemic Many parents have two burning questions. First, when can I get the vaccine? And second, when can my kids get it? It may come as a surprise that the answers are not the same. Adults will be able to get the vaccine by next summer. But their children will have to wait longer. Probably longer.
U.S. Thanks to the government’s Operation Operation thread speed and other programs, a number of Covid-19 vaccines for adults are already in advanced clinical trials. But no tests have yet begun in the United States to determine whether the vaccine is safe and effective for children.
“Right now I’m very concerned that we won’t be making vaccines available to children at the beginning of the next school year,” said Dr. Evan Anderson, a pediatrician at Children’s Healthcare in Atlanta and a professor at Emory University School. Medicine.
On Friday, Dr. Anderson and colleagues published a comment in the Journal of Clinical Infectious Diseases in which they called on vaccine manufacturers to come up with their own actions. They entitled him, “Rope Speed for Covid-19 Vaccines: Why Do Children Stuck in Neutral?”
In January, researchers began searching for the Covid-19 vaccine as soon as they isolated the virus. Teams of developers from around the world began creating vaccines based on a variety of techniques. For example, some used inactive coronaviruses that stimulate the immune system to make its own antibodies; Others transmitted viral genes to the body, interacting with immune cells.
Once they were ready to test that vaccine, they embarked on a well-worn path of decades of rigorous protocols developed to determine whether the vaccine was safe and effective. Vaccines require particularly rigorous testing because they are fundamentally different from drugs designed for a limited number of people who are sick with certain diseases. The vaccine, on the other hand, is given to millions of healthy people to prevent disease in the first place.
After testing the vaccine on animals, the developers begin clinical trials on humans. The trial comes in three stages, going from the smallest to the largest. Phase 1 and 2 trials give vaccine developers a figure out what doses will potentially be safe, while also providing the best immune protection.
Phase 3 trials, the final phase of vaccine testing, are conducted on thousands or tens of thousands of volunteers. During this study, scientists can find clear evidence that the vaccine protects people from any disease. They may also reveal side effects that were missed by small studies.
Many vaccines for measles, polio and tetanus were developed from scratch. In such cases, vaccine developers will start with trials, especially in adults, for any important safety issues.
Only if researchers find a serious side effect will they begin testing it in children, often starting with adolescents, then leading their way to adolescence. Vaccine developers are eagerly aware that children are not just miniature adults. Their biology is different in ways that can affect the way vaccines work. Because their airways are small, for example, they may be susceptible to lower levels of inflammation which can be detrimental to adults.
These tests allow vaccine developers to adjust doses to achieve optimal immune protection with the lowest risk of side effects. The dosage required for adults and children is sometimes different – children get the small amount of hepatitis B vaccine, for example, but larger doses for pertussis.
This process has proven to be safe and extremely successful. In recent decades, childhood vaccines have saved millions of lives. Increased use of the measles vaccine alone reduced mortality by 78 percent between 2000 and 2008, killing an estimated 12.7 million people worldwide.
In the past, the testing required for Food and Drug Administration approval on vaccines may have taken a decade or more. In recent years, researchers have determined ways to accelerate their development without sacrificing the research needed to demonstrate that they are safe and effective.
When the Covid-19 epidemic hit, some vaccine manufacturers sought to gather more data over the same period, figuring out how to connect the phases. Governments and philanthropists supported expensive clinical trials and factories to produce vaccines, which did not prove themselves.
The result has been an unprecedented and rapid march towards a vaccine. The epidemic has barely nine months, at least 38 covid – 19 vaccines have reached clinical trials, with dozens more ready to start in the next few months.
Early vaccinations for going into clinical trials by summer yield promising results. This vaccine produces no serious side effects in volunteers and produces promising levels of antibodies. At that point, they went into Phase 3 trials.
Dr. Anderson said the vaccine makers could have started running trials for children during the summer, sooner than they did with the good results of Phase 2 from adults. But that did not happen. And with autumn around the corner, it still hasn’t happened.
Whenever this trial begins, it may take more than a year for children to be vaccinated against Covid-19. Vaccine manufacturers need to write a protocol and get it approved by the FDA. They will need to recruit volunteers – since the pediatric vaccine is a time-consuming process, parents must give informed consent. It may take a few months to get the first injections.
As needed, the trial had to start small, the researchers probably gave only half a dozen children a low dose of the vaccine and then monitored it for several days. The trial can then be extended to dozens and then hundreds of children.
A few more months may pass when vaccine developers give small doses to a small group of children. Each group of children will need two months of monitoring to check their immune response and make sure there are no side effects. Only then will vaccine developers begin a new trial with higher doses.
These tests are likely to start with older children, before researchers can migrate to children between 3 and between. And only after collecting preliminary data from that test, will it be possible to start one for children under 3. Once the results of these tests have arrived, they will have to be put through an independent review before the FDA approves vaccines for children.
There were good reasons behind the early attention of adults. Children are less likely to die from Covid-19. On Friday, the Centers for Disease Control and Prevention released a report that found that of the more than 190,000 people who died in the United States with Covid-19, only 121 were under the age of 21. Similarly, the hospitalization rate in children under 20 years of age is 20 times lower than in adults.
“Children are not such a risky group,” said a University of Pennsylvania professor and member of the FDA’s vaccine advisory panel, who was not involved with the new comment. “Given the limited time and resources to do these tests, I can understand why the initial focus is on people over the age of 18.”
Dr. It fitted that the right time to start testing children could be after the first group of approved vaccines for health care workers and other high-risk groups comes out – perhaps in early 2021.
A pediatrician and vaccine specialist at the Ikhan School of Medicine on Mount Sinai, Dr. Christine Oliver also thought that tests for children should be waited for – at least until one or more vaccines have successfully passed stage 3 tests. “We don’t know which one of them will make it,” he said. “I’m very excited about a safe and effective vaccine, but I keep my enthusiasm in check.”
But Dr. Anderson and his colleagues don’t want to wait that long. In his remarks, he said that the Phase 2 test on children “should start from now.”
They argued that if a few children died from Covid-19, it was a death that could have been avoided by the vaccine. Also, there is a lot that doctors are learning about the effects of this new virus in children. In May, they discovered that it could lead to a completely new disease, called multisystem inflammatory syndrome in children, or MIS-C for short. Other long-term effects of the virus on children remain to be seen.
AstraZeneca, Johnson & Johnson, Moderna and Pfizer all said they were looking forward to developing a childhood vaccine.
“We agree with the importance and urgency associated with pediatric trials for vaccines against the modern Covid-19,” company spokesman Ray Jordan said in an email. “We plan to introduce pediatric tests in the near future, subject to regulatory approval.”
Pfizer spokeswoman Amy Rose said the company was actively working with regulators on a potential pediatric study plan to address the disease load in the pediatric population under the age of 16.
Dr. Anderson considered these statements to be little more than vague promises and there is no substitute for real steps towards pediatrics. “In the meantime we remain neutral with the ongoing death and disease in children.”
In addition to protecting the health of children, Dr. Anderson and colleagues argued that a Covid-19 vaccine, which could be ready by the start of the 2021 school year, could slow the transmission of the virus to students, their parents and school staff. Vaccinating children can help reopen society, ensuring that schools do not become hot spots for overheated occasions.
Associate Chief Medical Officer for Practice Innovation at Stanford Children’s Health and Professor of Pediatrics at Stanford University School of Medicine. “They’re absolutely fine,” Grace Lee said. “In order for us to reopen effectively, we will need vaccines for children, period.”
