BPOM called Sinovac Vaccine Approval for Seniors. Here are the details of the age range and dosage page.

JAKARTA, KOMPAS.com – The Food and Drug Administration (BPOM) is said to have given an approval signal for the injection of the Covid-19 vaccine manufactured by Sinovac for the elderly.

Reporting from Compass TV, Sunday (7/2/2021), based on the CoronaVac vaccine fact sheet published by the BPOM, the definition of elderly is those 60 years of age or older and those under 70 years of age.

Meanwhile, Sinovac’s research has so far been limited to people over the age of 70. So, until now, the BPOM has yet to provide guidelines for the provision of the Covid-19 vaccine manufactured by Sinovac for that age range.

Also read: BPOM allegedly approved the use of the Covid-19 vaccine manufactured by Sinovac for the elderly

Referring to the fact sheet of the BPOM National Drug Information Center on CoronaVac butan Sinovac vaccine, the age group for vaccine recipients is divided into two. Here are the details:

Adult (18-59 years)

For emergency situations, the vaccination schedule is two doses with a time interval of two weeks (day 0 and day 14). Where each dose is administered up to 0.5 ml.

For routine situations, the vaccination schedule is two doses at 4-week intervals (day 0 and day 28), where each dose is administered up to 0.5 ml.

Also read: China’s Foreign Minister Phones Luhut, Ready to Increase Cooperation on Vaccines and Overcome Covid-19

Elderly (60 years and over)

For the immunization of the elderly group, the immunization schedule is two doses with an interval of four weeks (day 0 and day 28). Where each dose is administered up to 0.5 ml.

However, the fact sheet states that research on CoronaVac for vaccine recipients age 70 and older is still limited. Meanwhile, the booster dose (booster dose) not specified.

Responses to Bio Farma

Meanwhile, the reports cite a copy of BPOM Chief Penny K Lukito’s letter to Bio Farma stating that approval was given in considering the emergency situation.emergency the Covid-19 pandemic outbreak and considering the limited evidence of the usefulness and safety of the vaccine for the prevention of Covid-19.

Based on these considerations, BPOM then gave approval for additional indications and posology for CoronaVac vaccines for use. emergency limited to the conditions of a pandemic outbreak.

Also read: Bio Farma will change the packaging of Sinovac’s Covid-19 vaccine

The letter from the Head of BPOM himself, according to various reports, is the response to Bio Farma’s letter to BPOM.

Bio Farma is applied for additional indications for the elderly population (60 years and over) with injection intervals of 0 and 28 days.

Furthermore, in the letter, it is reported that Bio Farma has proposed additional alternative injection intervals of 0 and 28 days for the adult population (18-59 years).

Meanwhile, China’s drug regulator conditionally approved Sinovac Biotech’s CoronaVac vaccine for wider use in China, outside of priority and high-risk groups with emergency use permits. Associated Press, Saturday (06/02/2021).

Previously, the vaccine was licensed for emergency use for priority and high-risk groups.

This conditional approval indicates that the vaccine manufactured by Sinovac can now be administered to the general public in China, although research is still ongoing, as with other vaccines.

Companies will be asked to submit follow-up data as well as a side effect report after the vaccine is sold on the market.

Phase 1 and Phase 2 clinical trials in China suggest that the vaccine can safely trigger an immune response in elderly clinical trial participants.

But Sinovac cautioned that data on the vaccine’s protection levels for people age 60 and older in clinical trials is limited.