COVID jabs safe despite US alert

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MANILA, Philippines — A vaccine expert assured Filipinos on Wednesday that all vaccines are safe after the United States Food and Drug Administration (FDA) warned about the risk of developing “very rare” heart conditions in those who were inoculated against COVID-19.

According to Dr. Nina Gloriani who chaired the country’s vaccine expert panel during the pandemic, Filipinos who received Pfizer’s Comirnaty and Moderna’s Spikevax COVID-19 vaccines are not in danger of developing myocarditis (inflammation of the middle layer of heart muscle) and pericarditis (inflammation of the heart’s outer lining) years after being jabbed.

“There will be no problems [for Filipinos who got Pfizer and Moderna as their COVID-19 vaccines],” she said in an interview on One News.

READ: COVID-19 global overview: Where are we now 5 years after?

“The vaccine-associated myocarditis would develop usually within a week after the vaccination, and usually after receiving the first or second doses. So we’re out of the woods,” said Gloriani, who is also a member of the Philippine FDA Scientific Advisory Committee.

In letters addressed to Pfizer and Moderna dated April 17 but made public only on May 22, the US FDA ordered the two pharmaceutical corporations to expand warning labels on their Comirnaty and Spikevax COVID-19 vaccines, which both use messenger RNA (mRNA) rather than part of an actual bacteria or virus.

The new warning highlights a rare risk of myocarditis and pericarditis mainly in young males aged 16 to 25. These conditions were observed to occur within seven days after receiving the COVID-19 vaccine.

The US FDA said the incidence occurred very rarely—in around 38 cases per million doses.

Rare side effects

Despite the findings, officials stressed that these side effects remain rare and typically mild. The US Centers for Disease Control and Prevention also noted that most of the vaccine-associated myocarditis and pericarditis were resolved quickly within a few days, and the benefits of vaccination still outweigh the risks.

Before this, Comirnaty’s label warned of an elevated risk for these conditions in the 12 to 17 age group, while for Spikevax, it was between ages 18 and 24.

According to Gloriani, they received reports and studies about the heightened risk for developing heart inflammation conditions before recommending to the Philippine FDA in 2021 the approval of the emergency use authorization (EUA) for the Pfizer and Moderna vaccines.

Based on the Philippine FDA data as of June 2024, there were 31 cases of myocarditis and four cases of pericarditis among the 113,218 reports of suspected adverse reactions to COVID-19 vaccines.

These very rare heart conditions occurred within 0.00000187 percent of the over 181 million COVID-19 vaccine doses administered from March 2021 to July 2023.

Of the more than 181 million COVID-19 vaccine shots administered to Filipinos, Pfizer’s Comirnaty was the most common with over 77 million doses (42.4 percent) among the seven brands granted an EUA. Moderna’s Spikevax was in fourth place at over 21 million doses (11.9 percent).

Gloriani said that at present, the US FDA instructions for Pfizer and Moderna will not affect the Philippines since there have been no COVID-19 mass vaccinations since July 2023, when the government lifted the state of public health emergency due to the pandemic.

Also, neither Comirnaty nor Spikevax are currently available in the Philippine market. /cb