Most young children can now get vaccinated with updated Omicron bi-valent vaccines following FDA decision

New York – According to the New York Times, nearly 100 million Americans have been infected with COVID-19 since the pandemic began in early 2000, and more than 1 million have died as a result of virus-related complications. This year, the country reopened, and people are getting used to living with the virus, although the pandemic is clearly not over and the number of cases is growing again as the weather gets colder and people spend more time indoors.

Some areas in the state of New York are already seeing a significant surge in new cases, and the CDC has updated the pandemic guidelines for at least 11 counties statewide, advising people living in those areas to wear face masks indoors. As we already reported, masks are now recommended in Westchester County, Rockland County, Nassau County, Suffolk County, Bronx County, Kings County (Brooklyn), Queens County, Tioga County, Broome County, and Richmond County.

An extreme surge in new cases and hospitalizations is not expected this winter because most people now have some protection against the virus, developed either through vaccination or recovery. Health officials, on the other hand, advise people to keep up with their vaccine schedule because the immunity developed through vaccination wanes over time. Pfizer and Moderna developed Omicron-specific bi-valent vaccines earlier this year in order to improve their vaccines against Omicron, currently the most common and infectious variant. The FDA later granted both manufacturers emergency use authorization for almost all age groups except for the youngest.

Late last month, the CDC released the results of their first study on the bi-valent vaccine boosters, and the agency found out that the updated bivalent COVID-19 booster vaccine increased protection against symptomatic disease compared with the original monovalent vaccine given as recently as two months ago. Months after the initial emergency use authorization, the FDA decided to expand emergency use authorization for the shots from Moderna and Pfizer-BioNTech to most children as young as 6 months old.

“More children now have the opportunity to update their protection against COVID-19 with a bivalent COVID-19 vaccine, and we encourage parents and caregivers of those eligible to consider doing so – especially as we head into the holidays and winter months where more time will be spent indoors,” said FDA Commissioner Robert M. Califf, M.D. “As this virus has changed, and immunity from previous COVID-19 vaccination wanes, the more people who keep up to date on COVID-19 vaccinations, the more benefit there will be for individuals, families, and public health by helping prevent severe illnesses, hospitalizations, and deaths.”

The FDA’s decision comes at a time when the number of new COVID-19 cases is rising, and this trend is expected to continue in the upcoming months. Getting the youngest vaccinated with the updated boosters is expected to provide upgraded protection against the highly contagious Omicron variant. When it comes to Moderna’s bi-valent Omicron vaccines, all children aged 6 months and older can get the booster at least two months after their last “monovalent” shot.

When it comes to those vaccinated with Pfizer’s, however, there are some limitations. According to the FDA’s statement, children 6 months through 4 years of age who have already completed their three-dose primary series with the original (monovalent) Pfizer-BioNTech COVID-19 Vaccine will not be eligible for a booster dose of an updated bivalent vaccine at this time because the agency still doesn’t have clinical data in that age group for a fourth dose. Those who have received two doses so far, can get the bi-valent booster shot.

The bi-valent booster vaccines were first rolled out in September. Since then, only 15% of the American population ages 5 and older have gotten an updated booster shot, while around 30% of seniors nationwide have been vaccinated with one of these vaccines. It still remains unclear why Americans are hesitant to get any of these vaccines, even though the White House administration bought millions of doses to make them available to everyone.

FDA officials have once again reminded Americans that getting vaccinated is still the best option we have for combating the virus. Hundreds of studies in recent years confirmed that getting vaccinated significantly lowers the chances of developing severe condition, hospitalization and death. Based on available data, the updated, bivalent vaccines are expected to provide increased protection against COVID-19.