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Researchers are racing against time to find a cure for COVID-19, which has so far infected over 32 million people and claimed 985,823 lives. Globally, nearly 200 vaccine candidates are reported to be under development, out of which 38 are being tested on humans. But the trials are mostly conducted on healthy adults aged 18 years or above. Why are kids being left behind? Normally vaccine trials are gradually expanded into children only after it has been found to be safe and effective in adults. However, many drugmakers seem to be discarding the usual method in order to develop a COVID-19 vaccine at a record pace. Should vaccine makers start including children in clinical trials? Here's what experts say.
It's time to start evaluating the vaccine candidates in the context of pediatric use, said authors of a paper titled "Warp Speed for COVID-19 Vaccines: Why are Children Stuck in Neutral?" published recently in Clinical Infectious Diseases.
They expressed fear that approval of vaccines without testing on children can put them at a higher risk for infection and further disease spread.
Generally, it takes up to eight years to license a vaccine used in adults for use in children. "If we follow the usual model, we will be in trouble and never be able to modify the COVID-19 pandemic because we will have a huge swath of the population about whom we know nothing in regards to the infection and vaccination," said Dr. Sharon Nachman, MD, Chief of the Division of Pediatric Infectious Diseases at Stony Brook Children's Hospital.
Therefore, Dr. Nachman and her team emphasize that "now" is the time to include children in COVID-19 vaccine trials.
The team of national pediatric infectious disease experts further noted that while clinical trials of COVID-19 vaccines on adults have moved quickly into Phase 3 stage, clinical trials have not started in children in the US. The experts do not see this as a good thing, given the fact that the direct COVID-19 impact upon children is greater than that of a number of other pathogens for which we now have effective pediatric vaccines.
Additionally, they noted that delaying Phase II vaccine clinical trials in children will unnecessarily prolong its impact upon children's education, health and emotional well-being.
Carefully conducted Phase II clinical trials on children can adequately address potential COVID-19 vaccine safety concerns, they added.
A few days ago, Chinese vaccine maker Sinovac announced its plan to launch a Phase I and II clinical trials later this month to test its vaccine in over 500 children ages 3 to 17 in China. But the news created a controversy in the scientific world, with some experts disapproving of the move. Conducting pediatric trials before a vaccine had first been proved to be safe and effective in adults may expose kids to a vaccine that doesn't work and will never get rolled out in the market, they argued. Others opine that waiting for more definitive efficacy results in adults may delay trials in kids.
Sinovac's vaccine candidate, called CoronaVac, is developed using an inactive version of COVID-19 to teach the immune system to build up tolerance against the disease. The company is one of nine coronavirus vaccine makers to reach Phase III trials. Currently, Phase III trials of CoronaVac are being conducted among thousands of participants in Brazil, Indonesia, and Bangladesh.
Sinovac is also one of the Chinese vaccine makers involved in the country's controversial emergency-use program. Hundreds of thousands of Chinese citizens, including frontline medical workers and other select population groups, were vaccinated even before Phase III clinical trials which are designed to prove the effectiveness and safety of a vaccine are completed.
Earlier this month, Dr. Yin Weidong, chief executive of Sinovac, told Reuters that as many as 3,000 Sinovac employees and their families have been given the CoronaVac shots.
American pharmaceutical giant Pfizer had also recently announced its plan to expand its Phase III trials in the U.S. to include included participants as young as 16. But the University of Oxford, which is developing a COVID-19 vaccine in partnership with pharmaceutical company AstraZeneca, has put off its initial plans to conduct a trial of their vaccine in children in the U.K. this fall.