CORONAVIRUS/Taiwan grants EUA for 2nd-generation Moderna COVID-19 vaccine (update)

09/02/2022 10:10 PM

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Taipei, Sept. 2 (CNA) Taiwan's Food and Drug Administration (FDA) has granted emergency use authorization (EUA) for Moderna's second-generation COVID-19 vaccines for adults aged 18 years old and above, after a meeting of experts Friday.

The recommended interval for the updated vaccine will be three months from previous doses, the FDA said in a press release following the meeting.

One dose (0.5mL) of the bivalent Moderna vaccine contains 25 micrograms of COVID-19 mRNA vaccine, which targets the original virus strain from 2020, and 25 micrograms that specifically targets the Omicron subvariant BA.1, the FDA said.

A safety review of the vaccine showed that common adverse reactions associated with the vaccine after injection are pain and swelling at the injection site, fatigue, headache, and muscle soreness, according to Lin Yi-chu (林意筑), an FDA specialist.

The adverse reactions, with severity ranging from mild to moderate, are similar to those after receiving a dose of the original Moderna vaccine, Lin said.

Earlier Friday, Victor Wang (王必勝), head of the Central Epidemic Commander Center (CECC) said Taiwan would decide on Sept. 5 how many doses of the updated vaccine it would buy and when it would take delivery of the vaccine.

The CECC is "looking to receive the vaccine by the end of September and begin vaccine administration in early October," Wang said.

The Advisory Committee on Immunization Practices will also meet on Sept. 5 to decide details about how to roll out the vaccine, Wang added.

The authorization came as Taiwan is likely in the midst of a new wave of COVID-19 infections driven by the BA.5 subvariant, prompting questions on whether the CECC will consider purchasing a Moderna BA.4/BA.5-adapted bivalent vaccine.

Responding to the concern, the FDA said exploratory analysis had shown that the bivalent Moderna vaccine (original and omicron BA.1) could also trigger an immune response against BA.4 and BA.5 Omicron subvariants, according to Friday's release.

Separately, Wang said the CECC decided to buy the bivalent COVID-19 vaccine (original and Omicron BA.1) due to its effectiveness against the BA.4 and BA.5 as per guidelines issued by the European Union and the World Health Organization.

The United States is the only country that has authorized the Moderna vaccine targeting the BA.4 and BA.5 Omicron subvariants, Wang said, adding that the U.S. FDA did not apply its standard process for issuing an EUA for the vaccine.

Moderna and Pfizer-BioNTech secured the U.S.'s approval for their vaccines targeting BA.4 and BA.5 Omicron subvariants on Aug. 31.

According to an Aug. 31 report from CNBC, the U.S. FDA's authorization was based on animal studies from the BA.5 boosters, in addition to human data from the BA.1 shots, citing Peter Marks, head of the FDA office responsible for reviewing vaccines.

Marks said the FDA used the same process for the authorization that it relied on in the past for switching the strains in flu vaccines, the CNBC report said.

According to a report from France 24, the vaccine developers only submitted data from animal trials and lab data to the U.S. regulator for their BA.4/BA.5 adapted vaccines

Using animal and lab data to solicit regulatory approval for retooled vaccines is not without precedent -- it is done regularly for flu vaccines that are revamped each year to combat new variants, France 24 noted in the report.

(By Shen Pei-yiao and Shih Hsiu-chuan)

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