Covid In Children Under 5 Years Of Age When Will The Vaccines Be Approved

As of April 27, Health Canada has not received applications from any vaccine manufacturer seeking COVID-19 vaccine approval for children under five years of age. However, Moderna says it is currently working on a submission to Health Canada for approval. Lack of vaccines, combined with high levels of transmission from the community, may cause some parents to be concerned about exposing their youngest children to infection. Dr. Martha Fulford is an infectious disease specialist and head of medicine at McMaster University Medical Center in Hamilton, OD. He said that until a vaccine proves to provide significant protective benefits to younger children, there is no reason to rush the process. “You can not vaccinate a child between the ages of zero and four until you have a vaccine that really does something for the child and where the benefit has been shown to outweigh any potential risk,” Fulford told CTVNews.ca in a telephone interview. on April 25th. “Eventually, I think we will have one, but do not rush.” Pfizer Inc. and BioNTech SE are currently in the process of developing a vaccine for children under five, while Moderna Inc. is working on developing its own version of this vaccine for children under six years of age. Early data published so far are limited to press releases communicated by pharmaceutical companies. In the case of Pfizer-BioNTech, an ongoing clinical trial evaluates the effectiveness of vaccines for children aged six months to four years. After two doses, the company found that the vaccine did not meet its immunogenicity criteria, said Dr. Dina Kulik, a Toronto-based pediatric emergency physician. That means the vaccine failed to elicit an effective antibody response among those in the study, he said. What the company has decided to do is extend its testing to include a third installment. Pfizer is expected to release the data in May, before being evaluated by the US Food and Drug Administration. “It was not approved because it was not effective, honestly,” Kulik told CTVNews.ca in a telephone interview on April 21. “He did not do what he was supposed to do, so why get a vaccine … if you are not going to see any benefit?” While it may be disappointing to see that two doses of the vaccine have not been as effective in children under the age of five as they were initially in teens or adults, it is typical for vaccine products made for children to be delayed and marketed later. despite products created for adults, said Dr. Jesse Papenburg, a pediatric infectious disease specialist at Montreal Children’s Hospital. “We are all so accustomed to such rapid success in randomized controlled trial data that show enormous effectiveness for adults so quickly,” he told CTVNews.ca in a telephone interview on April 26. “It’s not really unusual for children to develop vaccines [to] it takes more time to carry out these studies and to really try to find the lowest possible dose that triggers a protective immune response. “ The data released by Moderna is based on a study involving children aged six months to five years, with the results divided into two age groups – those who are six months and one year old and those between two and five years old. The results show that two doses of the vaccine were 43.7 and 37.5 percent effective in both groups, respectively. The company recently applied to the US FDA for approval of its vaccine. Both drug companies are expected to submit their applications to the FDA for approval before submitting them to Health Canada, Papenburg said, although Canada may see these applications for authorization within days or weeks of filing in the US. The goal of this review is to determine if the products work and are safe to use, he said. “These companies are prioritizing the US market because FDA approval has some weight internationally,” he said. “I would expect Health Canada to receive submissions, if not by the end of May, then sometime in June… based on the information provided by the FDA with the expected timetables.” However, looking at the data currently available on the effectiveness of these vaccines, Fulford said she is not entirely convinced that they will offer a strong benefit to children under the age of five. More data is needed to assess how much of these vaccines will reduce the burden of COVID-19 among children in this age group and how safe they will be before doctors can make recommendations for their use, he said. “For me, there are just more questions than answers at this point,” Fulford said. “You have to have a really exciting assumption that there will be a significant benefit from doing that.” ‘HHHH BAR’ ON VACCINATION EFFICIENCY IN CHILDREN According to Fulford, the bar for developing and approving vaccines for children is very different from that for adults. This comes from evidence that children tend to be at lower risk of adverse effects from COVID-19 infection, he said. Studies have shown that the risk of serious illness from the virus increases with age. “Children have a much higher bar in terms of vaccine effectiveness… and you need to be sure that you have discussed the negative effects,” he said. “When you have the group of people at lower risk for [severe] results from the disease, you must have the highest safety bar. “ Papenburg reiterated this sentiment, adding that the goal is for manufacturers to produce vaccines in the smallest possible dose. “The idea of ​​using the lowest possible dose really stems, in part, from the desire to have as safe a product as possible, as the disease we prevent in pediatrics is less deadly than in adults,” Papenburg said. “We are keeping vaccines at a slightly higher level in terms of child safety.” In the pediatric patients she is currently seeing, Kulik said that common symptoms such as fever, sore throat, fatigue and body aches continue to occur. But with the Omicron BA.2 subtype in particular, he said he also notices less difficulty breathing and more vomiting and diarrhea, as well as rashes that are often perceived as a disease of the hands, feet and mouth. “This particular strain seems to be more annoying than what I see professionally,” he said. “It’s uncomfortable, but it does not cause serious illness.… In general, children are doing well, but they feel very bad.” The fifth wave probably recorded the highest number of hospitalizations among children under the age of five in Canada, Papenburg said. As Canadians continue to go through a sixth wave, they continue to report hospitalization to this age group, but not in such large numbers, he said. According to data collected by Ontario Public Health as of April 25, the number of children aged 0 to 4 who were hospitalized in the previous two weeks was 47 in a total population of approximately 723,000. As of April 26, Quebec health authorities reported only seven treatments for children of the same age group. These figures are quite low compared to hospital admission rates for some of Canada’s elderly population, Fulford said. As a result, it is important to set a clear target for vaccines in children, Fulford said. Based on the vaccine program developed in Canada so far, the goal has been to largely prevent serious consequences as a result of COVID-19 infection, he said. But when it comes to an age group that is already at lower risk of these outcomes, especially compared to larger populations, this means that it is important to also weigh the risks and benefits of vaccination for each child individually. said Fulford. This includes taking into account existing comorbidities, such as obesity or diabetes, which tend to lead to a higher risk of serious outcomes as a result of infection. “Children who are in danger somehow know who they are,” he said. “They are the children who were at risk before being infected with COVID-19.” WHAT CAN BE DONE TO REDUCE THE RISK TO CHILDREN? “Apart from waiting for the COVID-19 vaccine to be approved for children aged four and under, it remains to be seen what the instructions for its use will be,” Fulford said. “Approving something is not the same as saying, ‘Everyone should get it now,’” he said. Once approved, the immunization advisory committees are expected to integrate the effects of the vaccine into a broader context, taking into account the burden of the disease on the population, as well as relevant risk-benefit analyzes to make recommendations on the use of these vaccines. “Both are possible [vaccines] will it be recommended with the same effect or will there be a preferential recommendation for one product over another? ” said Papenburg. “That’s what it’s [the National Advisory Committee on Immunization] will consider, in the context of the ethics of justice, acceptance and expediency “. Another important question that remains to be answered is what would be the potential benefit of COVID-19 vaccination in young children who are already infected, Fulford said. A study conducted during the Alpha and Delta waves in England shows that re-infection rates appear to be lower among children than in adults, for example, but the latest data on the subject remain limited. In the United States, recent data from the Centers for Disease Control and Prevention show that nearly three-quarters of children nationwide have been infected with COVID-19 in the past. Omicron…