Jannsen starts COVID-19 vaccine trial, Sputnik-V still needs EUA

 

MANILA — Belgian drug maker Janssen Pharmaceutica has started the clinical trial for COVID-19 vaccine in the Philippines, says the Department of Science and Technology (DOST).

“Janssen has already started the clinical trial proper, which covers patient screening, recruitment and vaccination,” DOST undersecretary Rowena Guevara said in a briefing.

The country’s Food and Drug Administration (FDA) approved the application of Janssen to conduct clinical trials in December last year.

Janssen trial are conducted in Metro Manila. The specifics as to the date when the study commenced or the barangays where the trials are held remain undisclosed.

Earlier clinical trials show that a single dose of the Janssen vaccine has an efficacy rate of up to 72%. Developed by Janssen Pharmaceutica, a Belgium-based division of Johnson & Johnson, the vaccine leverages the company’s AdVac platform, which was also used to develop and manufacture Ebola vaccine regimen and construct its Zika, RSV and HIV investigational vaccine candidates.

The Janssen COVID-19 shot can be refrigerated for up to three months at 2 to 8°C, which is the standard temperature that is within the existing cold chain system in the country.

In other developments, Chinese firms Clover Biopharmaceuticals and Sinovac are still preparing the sites for their studies.

 

The Russian Sputnik-V COVID-19 vaccine still needs EUA

Earlier, FDA director-general Eric Domingo advised the Russian embassy to provide an authorization letter to help expedite the granting of an emergency use authorization (EUA) for Russia’s Sputnik-V Covid-19 vaccine.

While Sputnik-V Covid-19 vaccine has been granted EUA from other countries like Argentina and Russia, its EUA application in the Philippines is still pending.

Domingo said in an online meeting of the House committee on people’s participation, the authorization letter must assure the FDA that Gamaleya Institute’s local representatives in the country can sign the documents needed for their EUA application.

“So maybe if the [Russian] embassy can give some authorization, a letter that will allow FDA, assure FDA that their local representative here is authorized by the manufacturer Gamaleya to sign these documents for them, that will make it [the application process] faster,” he said.

Domingo added the Gamaleya Institute must submit a good manufacturing practice (GMP) certification “assuring the consistency of the quality of their product.”

The Government would schedule a GMP inspection of their factory once the manufacturer has applied for it.

“We have a team here in the Philippines that is ready and capable of doing a GMP inspection,” Domingo said. “The Russian Government is also very willing to help us coordinate so that we can send our inspection team there to inspect the factory.”

The FDA has granted EUA to AstraZeneca’s Covid-19 vaccine and Pfizer-BioNTech’s Covid-19 vaccine last month. It is still processing Sinovac Biotech’s bid for EUA of its Covid-19 vaccine.

Meanwhile, the Government’s vaccination program has yet to commence, as according to vaccine czar Carlito Galvez, the indemnification requirements caused the delay of the arrival of COVID-19 shots from the COVAX facility.

To date, the Philippines has over 555,000 cases, with 11,673 deaths. (JSM/JuanManila)


Featured image: A person holds a vial of Janssen’s investigational COVID-19 vaccine candidate. (Photo via Johnson & Johnson website.

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