How NPRA Approved Sinovac, AstraZeneca, Pfizer Covid-19 Vaccines

Malaysia’s National Pharmaceutical Regulatory Agency says a Brazil trial shows Sinovac’s Covid-19 vaccine is 50.65% effective, barely fulfilling WHO’s minimum 50% efficacy standard.

KUALA LUMPUR, March 19 — The National Pharmaceutical Regulatory Agency (NPRA) said it conditionally approved Covid-19 vaccines by Sinovac, AstraZeneca-Oxford University, and Pfizer-BioNTech as they cleared the minimum 50 per cent efficacy rate recommended by the World Health Organization (WHO).

The Malaysia pharmaceutical regulator cited Phase Three clinical trial data that show the Sinovac, AstraZeneca, and Pfizer vaccines are 50.65 per cent, 70.42 per cent, and 94.6 per cent effective respectively in preventing Covid-19 disease.

“The vaccines have been rigorously evaluated and the decision is made by the Drug Control Authority (DCA) by consensus that in the interest of public health, the benefit of immediate availability of the vaccines outweighs the risk, inherent in the fact that additional data are still required,” Health Minister Dr Adham Baba told CodeBlue, quoting answers by the Ministry of Health’s (MOH) pharmacy regulatory division.

“Clinical studies for all these vaccines are currently still ongoing. Further monitoring of the efficacy and safety will be needed in order to ensure that the benefit over risk of this vaccine remains positive.

“The validity of this conditional approval is one year. During this period, the DCA will periodically be updated with all necessary information related to the quality, safety and efficacy of this vaccine. The registration can be revoked at any point if the conditions are not fulfilled by the product registration holder or if the benefit over risk of the vaccine is no longer deemed beneficial to the public.”

Sinovac Biotech, a biopharmaceutical company based in Beijing, China, has yet to publish the Phase Three trial results for its Covid-19 vaccine in a peer-reviewed journal, only publishing combined Phase One and Two results in medical journal the Lancet last November. Governments of the countries where Phase Three trials took place released their own data instead.

Malaysia’s NPRA, in its evaluation of Sinovac’s vaccine, cited the interim analysis of a Phase Three clinical trial among health care workers in Brazil on 12,396 participants that showed CoronaVac was 50.65 per cent effective — barely clearing regulatory approval — in preventing symptomatic Covid-19 after two doses. 

“This fulfilled the efficacy standard as recommended by WHO, where the primary efficacy endpoint point estimate for a placebo-controlled efficacy trial should be at least 50 per cent,” MOH’s pharmacy regulatory division told CodeBlue.

“More data is expected from other ongoing Phase Three trials in Indonesia (planned 1,620 subjects) and Turkey (planned 12,450 subjects) on a rolling review basis.”

According to the package insert of Sinovac’s vaccine on NPRA’s website, Sinovac’s vaccine in the Brazil trial showed up to 83.7 per cent effectiveness in preventing Grade Three Covid-19 cases and full protection against severe disease. 

The package insert also states 65.3 per cent effectiveness of the Sinovac vaccine in preventing symptomatic Covid-19 in an ongoing study in Indonesia, without specifying the number of participants. Official interim analysis of an ongoing trial in Turkey is still pending.  

While Sinovac has yet to publish the Phase Three trial results of its Covid-19 vaccine in a peer-reviewed journal, the full results of final-stage clinical trials for Pfizer-BioNTech’s and AstraZeneca-Oxford’s vaccines were published in the New England Journal of Medicine and the Lancet last December.

NPRA’s evaluation of Pfizer’s coronavirus vaccine cited the final analysis of a Phase Three clinical trial involving 36,621 participants across countries like the United States, Turkey, Germany, South Africa, Brazil, and Argentina that found the vaccine was 94.6 per cent effective in preventing Covid-19 disease.

For AstraZeneca’s vaccine, NPRA cited the pooled analysis of Phase Three clinical trials conducted in the United Kingdom and Brazil involving 11,636 volunteers that found 70.42 per cent efficacy in preventing symptomatic Covid-19.

Although NPRA has given conditional registration to Sinovac’s Covid-19 vaccine, the regulator has yet to approve Pharmaniaga’s fill-and-finish facility for the final manufacturing of CoronaVac. Malaysia received 100,000 “finished” Sinovac doses last Monday, with another 100,000 doses scheduled for delivery on March 22.

Who Evaluated Covid-19 Vaccines?

MOH’s pharmacy regulatory division told CodeBlue that the evaluation of Covid-19 vaccines was conducted by regulatory pharmacists in NPRA who are “experienced, well-versed, and trained in this field”.

“In addition, expert opinion is sought from the key opinion leader or specialist, including the experts in the field of infectious disease, public health, pathologist, immunology, virology, clinical research, clinical epidemiology, and academicians.”

Conditional registration was issued for Covid-19 vaccines in light of the pandemic, with a priority review process taking 120 working days from the date the complete application is received by NPRA, shorter than the usual 245-working day registration process for new drugs and biological products.

According to MOH’s pharmacy regulatory division, vaccines for human use are regulated under the Poisons Act 1952, as well as the Sale of Drugs Act 1952, and the Control of Drugs and Cosmetics Regulations 1984.

How To Report Vaccine Reactions?

People who receive Covid-19 vaccines can report any adverse event following immunisation (AEFI), or a negative medical occurrence after vaccination, to NPRA through MOH’s MySejahtera app. 

“Vaccinees get reminded (at Day 1, 3, 7 and Day 14 for the first dose) to report AEFIs that they experience,” MOH’s pharmacy regulatory division told CodeBlue.

Those who get inoculated against Covid-19 can also report AEFI through the current method of reporting adverse drug reactions for medicines in Malaysia by using the Consumer Side-Effects Reporting Form from NPRA’s website.   

Health care professionals who treat people’s reactions from coronavirus vaccines can file reports through the Pharmacy Information System (PhIS) via NPRA’s website or by filling the hardcopy forms and sending them to NPRA’s National Centre of Adverse Drug Response (ADR) Monitoring via email or post. 

“The information on how to report AEFI is communicated to vaccinees during vaccination and the information is also stated in their vaccination reminder card,” said MOH’s pharmacy regulatory division.

“In addition to AEFI’s monitoring locally, NPRA is also working closely with the product registration holder, WHO and other regulatory agencies in order to monitor the safety of the vaccine. If there is any new safety signal detected, a thorough evaluation will take place to evaluate the benefit vs risk of the vaccine. If warranted, regulatory actions such as product recall or withdrawal, product information updates will be taken promptly.”

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