How Did Cuba Become the First Country to Vaccinate Young Children?

Cuba on Monday became the first country to administer COVID-19 shots to children as young as two years old. 

Experts say the move is dicey, as the government has not allowed time for an adequate trial and is using a vaccine that is not recognized by the World Health Organization (WHO).

The country is using its own vaccine, Soberana 2, which claims to be 90% efficacious when combined with a booster called Soberana Plus. Data on Cuba’s vaccines has not been published in peer-reviewed journals, but local health authorities have authorized them for emergency use, according to Reuters.

“I was fascinated by this,” Judith Flores, MD, a pediatrician and a fellow at the American Academy of Pediatrics and the New York Academy of Medicine, tells Verywell. “It's very, very risky. It's certainly not something we would do here with the protections that we have with the FDA.”

Cuba’s Medicines Regulatory Agency (CECMED) authorized Soberana 2 for emergency use on August 20 for people aged 19 and above. Developed by the state-owned Finlay Vaccine Institute, Soberana 2 is a recombinant protein vaccine like Novavax, a U.S.-developed vaccine that’s currently under trial. 

The CECMED authorized the vaccine for people ages 2 to 18 after Phase I and II clinical trials found that the vaccine was “well tolerated” in children and adolescents aged between 3 and 18.

Flores sees the decision as a result of three factors: Cuba’s rising infection rates, dipping economy, and the race to get children back in school.

Since the start of the pandemic, Cuba has recorded over 700,000 confirmed COVID-19 cases and 5,881 related deaths, according to the WHO. Both cases and deaths have sharply risen this summer. 

Economically, in addition to U.S. sanctions, Cuba’s tourism industry has suffered from pandemic travel restrictions.

“They're really drowning in infections, hospitalizations, and they're choking economically,” Flores says. “They want to get the kids back to school and they want to get their economy open.”

She adds that ensuring vaccines are safe and effective for designated age groups is necessary in reopening Cuba’s schools and economy. Americans will need to wait longer for the COVID-19 vaccines to be authorized for younger children, but should feel a sense of comfort knowing that the process is under rigorous review, she says.

The long history of trade embargoes by the U.S. motivated Cuba to develop a homegrown vaccine instead of relying on external aid, vaccine designer Vicente Vérez Bencomo told the journal Nature.

“Life is proving us right,” Vérez Bencomo said. “What we’re seeing across the world is that vaccine supplies are being hoarded by rich countries.”

When Can Children Get Vaccinated in the United States?

In the United States, vaccines by Pfizer and Moderna are authorized for people aged 12 and older. Trials are currently underway to see how the vaccine will perform in children who are younger.

Pfizer and Moderna both began their clinical trials for children ages between 6 months and 11 years old, which are scheduled to complete in 2023. While there may be a delay with Moderna, Pfizer is expecting to file a request for emergency use authorization for children aged between 5 and 11 by the end of September.

Flores expects a vaccine for younger children will be authorized by Christmas or sooner, though hesitancy will come along with it. In her practice, she works to combat vaccine hesitancy through educational outreach and vaccination training in people’s native language.

“We would have overcome a lot of that, had we had a good system of language access, health literacy access, and just general health access,” Flores says, who is bilingual in English and Spanish. “We're learning a lot.”

It’s hard to compare the situation in the U.S. to that in Cuba, where parents may not have the option to be vaccine hesitant, she adds. She would not want the U.S. to follow Cuba's example of a rushed approval, but says it’s important to follow the data and stay informed on the country’s situation.

“It's a little dicey,” Flores says. “I'm gonna watch it. Maybe we'll learn something from them.”

For now, U.S. parents can look to local and national health organizations for information on when their children can receive a vaccine. 

The information in this article is current as of the date listed, which means newer information may be available when you read this. For the most recent updates on COVID-19, visit our coronavirus news page.