Is It Safe For The Elderly In Indonesia To Be Injected With The Sinovac Vaccine? Let Me Not Be Curious, These Are The Results Of Clinical Trials In Brazil And China

Illustration (Pixabay)

JAKARTA - The Food and Drug Administration (BPOM) issued an emergency use authorization (EUA) for the Sinovac vaccine to be injected into the elderly.

Sinovac's emergency clearance for the elderly was issued on February 5. This is based on reports of clinical trial results in Brazil and China.

"At the end of January, phase 2 clinical trials in China and phase 3 in Brazil in the age group over 60 have reached a sufficient number of subjects and have been submitted to the POM," said BPOM head Penny K. Lukito in a virtual press conference on Sunday. , 7 February.

Penny explained, the phase 3 clinical trial in Brazil involved 600 elderly subjects. As a result, the administration of this vaccine in the age group of 60 years and over stated that the vaccine was safe and had no side effects in the form of death or serious side effects reported.

"Mild side effects generally occur, namely pain at the injection site, nausea, fever, swelling, redness of the skin and headaches," said Penny.

However, none of the clinical trial subjects in Brazil were over 70 years of age. Therefore, there needs to be special consideration, assistance from the accompanying doctor and conducting screening at the time of vaccine administration at the age of over 70 years.

Meanwhile, the phase 2 clinical trial in China involved about 400 elderly subjects. The results showed that the Sinovac vaccine which was given 2 doses with a distance of 28 days showed good immunogenicity results. Then, there was an increase in antibody levels after 28 days of giving the second dose, amounting to 97.96 percent.

"Based on the results of these discussions, the POM has issued an approval for the use or emergency use authroziation of the CoronaVac (Sinovac) vaccine for ages over 60 years with 2 doses of vaccine injections given in 28 days intervals," he added.