Panel of experts from the US Food and Drug Administration conversed and unanimously recommended Covid 19 Vaccines for children under five. The final age group waiting for this immunization is most of the countries.
Apart from these formal authorizations for Moderna and Pfizer should also follow soon. With the first shots in arms expected early next week. It is just over a year and a half after the first covid vaccines are given greenlight for elderly people in December 2020.
The recommendation does fill a significant unmet need for the really ignored children population, said by Mr. Michael Nelson, professor of medicine in the University of Virginia. He is one of the 21 experts that were asked to vote for the milestone meeting.
Unlike the regulators in other countries, FDA has offered livestreams of its internal deliberations and its stamp of approval is also considered the global gold standard.
In opening the discussion, the senior FDA scientist Mr. Peter Marks has said that despite the studies showing the majority of children have now been infected with coronavirus. It is observed that the high rate of hospitalizations among infants, toddlers and young children during the last winter of the Omicron wave underscored an urgent need for vaccination.
He also said that we are now dealing with an issue where we have to be very careful we don’t become numb to the pediatric deaths because of the overwhelming number of older deaths.
He also stated that every life is important and only vaccines can prevent the deaths are something we would like to try to do something about.
The United States of America has recorded about 480 Covid deaths in the age group of 0 to 4 in the pandemic. This is higher than even a bad flu season Said by Peter Marks.
Till the Month of May 2022, there have been 45, 000 hospitalizations in the age group of 0 to 4 and nearly a quarter of which required intensive care.
Apart from this meeting, FDA also posted its independent analyses of pharmaceutical companies’ vaccines, deeming both safe and effective.
Both the vaccines are mainly based on messenger RNA, which delivers the genetic code of coronavirus. That spike protein to human cells that then grow on the surface, training the immune system to be ready. This technology is now considered the leading Covid vaccination platform.
Pfizer has sought authorization for three doses at three micrograms that are given to children aged six months through four years, while moderna has asked for the FDA authorization of its vaccine as two doses of higher 25 micrograms for ages six months through five years.
Both these vaccines were tested in trials on thousands of children. They were found to cause similar levels of mild side effects as in older age groups and triggered similar levels of antibodies.
Efficiency against CoronaVirus infection has been higher for Pfizer, with the company placing it at 80 percent, compared to Moderna’s estimates of 51 percent for children aged six-months to two years old. About 37 percent for those aged two to five years.
But Pfizer’s figure is mainly based on very few cases and thus it is considered as preliminary. It will also take three doses to achieve its protection. With the third shot it gives eight weeks after the second, which is given in three weeks after the first one is given.
Moderna’s vaccine should also provide strong protection against the severe disease after two doses, that is given four weeks apart. Company is studying adding a booster that would raise the efficiency level against the mild disease.
However, Moderna’s decision is to go with a higher dose which is associated with higher levels of fevers in reaction to the vaccine as compared to Pfizer.
According to data there are about 20 million US children aged four years and under.
Although obesity, neurological disorders and asthma are also associated with increasing the risk of severe disease among young children. It is not easy to predict severe outcomes.
64 percent of hospitalizations in those under five years occurred in patients without any comorbidities.
Children can also contract with multisystem inflammatory syndrome in children (MIS-C). It is a rare but serious post viral condition. Some three to six percent can experience long Covid symptoms for more than 12 weeks.
FDA is expecting to soon act on the panel recommendations, and the matter will also go to the Center for Disease Control and Prevention for a final say.
White House officials said last week that rolling out of 10 million shots at pharmacies and doctors, officers could begin as soon as June 21 of 2022.