Covid-19 vaccine for children aged 5 to 12: a critical examination of the essential problems, from safety to cost

Think back to this time last year. Just thinking about it makes me shiver. India was fighting against the second wave of the deadly Covid-19 virus. People were in trouble, and the health care systems couldn’t keep up.

The experience forced the government, epidemiologists, scientists, and health care experts to start thinking about and getting ready for a possible third wave. In May 2021, a theory was made that a third wave might affect children primarily because, unlike adults, they would not have been vaccinated.

Even though there wasn’t enough scientific proof to back up this idea, some states started getting ready for it to happen. But it scared parents, and many of them prayed that vaccines would be ready soon for their kids.

Six months later, in January 2022, India started vaccinating children ages 15 to 17 as part of the first phase. This happened simultaneously as the third wave in the country when the number of cases rose quickly, but most people did not get very sick. The second round of vaccinations for kids ages 12 to 14 began in March.

Bring things up to date.

The government is thinking about letting kids from 5 to 12 years old get shots. About two weeks ago, the Drugs Controller General of India (DCGI) gave emergency-use authorization (EUA) to two vaccines: Bharat Biotech’s Covaxin for children aged 6 to 12 years and Biological E’s Corbevax for children aged 5 to 12 years. These vaccines are already given to kids older than 12 years old.

Chairman of the Covid-19 working group of the National Technical Advisory Group on Immunisation (NTAGI) NK Arora said, “We will look at data like the number of infections in children and how serious the disease is. Once we’ve looked over and analyzed the data, we’ll decide based on what we know.” He also said that things should become more apparent over the next two weeks.

Getting kids as young as 5 years old vaccinated is being thought about, but a few things are being discussed. Does it make sense to vaccinate all children against Covid-19? Are the vaccines that are available safe and sound? Should this age group be part of the government’s immunization program?

One of the daily news talked to several pediatricians and experts on vaccines to learn more. Let’s answer each question in turn.

The need to vaccinate kids against Covid-19

During the two years of the pandemic, it has been seen that children are less likely to get severe Covid-19 than adults are. Most of the time, they have no symptoms or only mild infections, and there aren’t many hospitalizations or deaths. But Covid-19 can be dangerous for children who already have health problems, and this makes people wonder if all children should be vaccinated or just those with health problems.

Most pediatricians think that all kids should get shots. Their thinking was that it would protect them from severe Covid-19 and cut down on the spread of the virus in the community.

“Children are part of our community, and we need to protect them because no one is safe until everyone is safe,” says Pramod Jog, a pediatrician in Pune. “Children aren’t very likely to get sick from Covid-19, but some may have serious problems.”

Jog says that India has a lot of children with health problems like diabetes or cancer, as well as a lot of children who aren’t getting enough food. Also on the rise is the number of obese children. “All of these are risks for Covid-19. So kids should get shots,” he says.

Since about a year ago, children in many developed and developing countries have been vaccinated against Covid-19.

It’s important to know that vaccines won’t stop you from getting Covid-19 or getting it again, but they will keep you from getting the worst forms of the disease.

The US Centers for Disease Control and Prevention (CDC) says that children with existing medical conditions are more likely to get very sick, but other children can also get very ill. Current evidence suggests that Covid-19 can make it more likely for children with special health care needs to get very sick, such as genetic, neurological, metabolic, or congenital heart disease.

Like adults, children who are overweight, have diabetes, asthma, chronic lung disease, sickle cell disease, or weakened immune system can also be at a higher risk. Even though it doesn’t happen very often, some people who have had Covid-19 may get multisystem inflammatory syndrome in children. The CDC says that keeping kids and teens from getting Covid-19 is essential to stop the spread of the virus and keep them from getting sick.

Since the vaccination program for teenagers in India started in January, about 145 million doses have been given.

Some experts don’t think it’s a good idea to vaccinate children because seroprevalence surveys show that 70–80% of children in India already have antibodies against Covid-19. This means they are immune to the disease and can fight it independently. Also, there is no information about how well vaccines protect against the Omicron variant, the most common right now, and its sub-variants.

The World Health Organization (WHO) says that most children have a low risk of getting a severe disease, so getting vaccinated would mainly help stop the spread of the disease. There are signs that vaccines may not be as good at stopping the spread of Omicron as they once were.

But the evidence is coming out of studies worldwide that hybrid immunity gives adults the best protection against Covid-19. Hybrid immunity is a type of immunity that comes from both natural infection and getting all of your shots.

“It’s essential for kids to live everyday lives. Schools are back in session, and we need to ensure they are safe. The available vaccines are safe and protect against different types of disease to various degrees. Even though Omicron is the most common form right now, we still see cases of the Delta form. New versions will keep coming out, but vaccines have been shown to prevent severe Covid-19 worldwide, so children should get vaccinated, says Amish Vora, a pediatrician in Mumbai.

Due to the low risk of acute Covid-19 in children and the lack of information about the side effects of both the vaccine and the disease, the balance of risk and benefit is more complicated for this age group than for others. When new variants appear, the risks and benefits need to be re-evaluated. To do this, India needs to set up systems to conduct relevant studies and collect and analyze data to help it make sound policy decisions.

A look at the vaccines for kids
Children worldwide are getting the two mRNA vaccines from Pfizer and Moderna and the two inactivated virus vaccines from China, Sinopharm, and Sinovac.

So far, the Indian government has given emergency approval to four vaccines for children: Covaxin (for ages six years and up), Corbevax (for ages five years and up), Covovax (for ages 12 years and up), and ZyCoV-D (for ages 12 years and up). Covovax is also trying to get approval for children ages 7 to 12.

In phase II/III clinical trials that the companies did on children, these vaccines were safe, well-tolerated, and made the kids’ immune systems more robust. But there haven’t been any tests of how well it works on children.

In December 2021, Bharat Biotech said that trials of Covaxin showed that neutralizing antibodies were on average 1.7 times higher in children than in adults.

Corbevax, the vaccine that Biological E made with Texas Children’s Hospital and Baylor College of Medicine in Houston, Texas, has been tested on 4,000 people of different ages.

“We put Corbevax and Covishield to the test and found that Corbevax gave better immune response in neutralizing antibodies against ancestral and Delta strains. Corbevax has also been shown to make a lot of antibodies that are effective against the Beta and Omicron variants. “The immune response in trials with children is the same as what we saw in trials with adults,” says Lakshminarayana Neti, chief operating officer of Biological E.

Due to its well-established subunit vaccine platform, Corbevax was well tolerated in all the studies and showed excellent safety, even in 5–18-year-old children. In any of the trials, there were no severe side effects caused by the vaccine, and Neti says that most of the reactions were mild.

Novavax, a company in the US, has given Serum Institute of India the right to make Covovax. This vaccine is also made of tiny pieces of protein. Novavax has done large-scale trials in the United States and Europe, but Serum Institute has done bridging phase 2-3 clinical trials on adults and children in India. In tests worldwide, the vaccine has worked 90% of the time.

Pediatricians say that the vaccines for children in India are made on safe platforms that have been used for a long time. Many vaccines for other diseases have been used for years and are based on inactivated virion or protein subunit platforms. Because of this, they don’t worry too much about how safe these Covid-19 vaccines are. Also, the experience with people ages 12 to 17 has been good so far, as there have been no severe side effects from the vaccines.

But Davinder Gill, an expert on vaccines and the former CEO of Hilleman Labs, says that the companies have only done immunogenicity studies in children, not formal investigations of how well the vaccine works. This could make people less interested in giving vaccines to everyone in that age group. Even if a vaccine works for adults, that doesn’t mean it will work or work the same way for kids.

Arora, who works for NTAGI and is also a pediatrician, says, “If something works for adults, it’s likely to work for kids, too.

Safety is the most important thing we look for in children. From a child’s point of view, safety is just as important, if not more important. Effectiveness is there; that’s what brings them all together.”

In terms of public health
When deciding if vaccination for a particular disease and a specific age group should be part of the government’s immunization program, its risk versus benefit and cost versus benefit need to be figured out.

Gagandeep Kang, a professor at the Christian Medical College in Vellore and a leading virologist, says that vaccinating children against Covid-19 as part of the government’s immunization program won’t make sense from a risk or cost-benefit point of view since data shows that most children don’t get sick even when they are exposed to it a lot.

In the last fiscal year, India spent about INR39,000 crore on vaccinations. The government has set aside INR5,000 crore in the Budget for FY23 for the Covid-19 vaccination.

Other health problems that need to be fixed have been put on the back burner because of the pandemic. Kang says that instead of just focusing on the Covid-19 vaccination, the government should put money into resources to prepare for the next wave, get more data, do effectiveness studies, and find new variants.

Covid-19 vaccines for kids can be sold on the open market or in private hospitals, but the government has to give full approval, not just EUA, for that to happen. There are a lot of vaccines that pediatricians recommend, like the ones for chickenpox or hepatitis A, that are not part of the government’s program because they don’t hurt children very much. She says that this needs to be taken into account.

The jury may still be out on whether or not to vaccinate kids between the ages of 5 and 12, but worried parents have options, and most pediatricians favor vaccinating against Covid-19.

edited and proofread by nikita sharma