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

A person holds Janssen's investigational COVID-19 vaccine candidate.

 

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.

PNP: 19,086 motorcycle-related crimes for 2016-2020

Gordon blasts LTO's glaring failure | Senator Dick Gordon

 

  • LTO’s failure to fast track the production of license plates and processing of vehicle registrations “is abetting motorcycle-riding criminals,” brought up in the Senate hearing
  • Implementation of the Motorcycle Crime Prevention Act, which mandates larger, readable and color-coded license plates is stalled because of the failure of the LTO and other government agencies
  • Senator Dick Gordon alleges Des Marketing Inc., Des Strong Motors, Du Ek Sam Inc. and Premio Corp. as well as other motorcycle importers have contributed to the rising crimes in the country
  • PNP has 52 percent unresolved crimes cases related to motorcycle-riding assailants for lack of license plates or proper documentation to track down the suspects

MANILA — During the Senate hearing, PNP records show that from 2016 to 2020, motorcycle-related crimes reached 19,086. Of the number, only 9,040 or 48 percent were resolved.

 

Gordon blasts LTO’s glaring failure

Sen. Richard Gordon, chair of the Senate Blue Ribbon committee which looks into the failure of the Land Transportation Office (LTO) and other government agencies to implement the Motorcycle Crime Prevention Act, which mandates larger, readable and color-coded license plates, says is abetting motorcycle-riding criminals.

Gordon, author of Republic Act No. 11235, pointed out that the number of people being killed by riding-in-tandem assassins in the Philippines continues to rise, hence, there is an urgent need for the implementation of the measure.

The failure of the LTO to fast track the production of license plates and processing of vehicle registrations, coupled with the alleged illegal practices of top motorcycle dealers had caused thousand of unsolved cases attributed to motorcycle-riding assailants because of lack of license plates or proper documentation to track down the suspects.

His office has monitored 147 victims of motorcycle-riding gunmen reported in the news from 1 January to 31 December 2020, while there have been eight victims from 1 to 16 January this year.

“These assassins continue to terrorize the country and people are being murdered just like that even at this time of a pandemic. The continuous and unabated killings are increasingly alarming. Masyado nang talamak ang mga patayan (Killings are rampant),” Gordon said in news reports.

 

Criminal activities on the road, in the bureau

“If motorcycles are not registered or not assigned plates, they can easily be used for criminal activities, to kill people,” Gordon said.

“Your registration process must be unsullied, and you must not connive with anybody,” he added, referring to the motorcycle dealers.

From 1 January to February alone, Gordon said, 59 people, including police officers and local officials, were victimized by motorcycle-riding suspects. Of this figure, 50 were killed, citing data collated by Gordon’s staff.

 

Importers summoned

Also summoned to the hearing were representatives from Des Marketing Inc., Des Strong Motors, Du Ek Sam Inc. and Premio Corp. as well as other motorcycle importers that Gordon alleged have contributed to the rising crimes in the country.

Trade and Industry Secretary Ramon Lopez told the panel that the agency’s Fair Trade Enforcement Bureau has received some 3,060 complaints from consumers who have purchased motorcycles from these dealers.

 

PNP shows record on crimes involving motorcycle 

PNP records show that of 9,040 or 48 percent of cases involving motorcycles were resolved. From 2016 to 2020, motorcycle-related crimes reached 19,086.

Philippine National Police chief Gen. Debold Sinas said the PNP has deployed tactical motorcycle-riding units (TMRUs) to go after criminals.

There are over 2,000 trained PNP personnel that form part of TMRUs, with eight teams assigned per urbanized area.

 

Where are the license plates, LTO?

Meanwhile, LTO chief Edgar Galvante said the agency was rushing the production of license plates, with 1.4 million pieces produced so far.

R.A. 11235 mandates the use of bigger, readable, and color-coded plates so that motorcycles used in crimes can be easily identified and the use of stolen number plates can be prevented, as well.

The new plate measures 235mm in width and 135mm in height. The old plate is 200mm x 225mm.

The law also requires the LTO to maintain a registry of motorcycles to facilitate information retrieval for official investigation and law enforcement purposes. (JSM/JuanManila)


Featured image: Senator Dick Gordon, chair of Senate Blue Ribbon Committee, during a Senate hearing on the rising crimes related to motorcycle-riding assailants. (via PNA)

IATF to pension institutions: Find ways to serve seniors better

IATF directs pensioners to service senior citizens differently

 

MANILA — The Inter-Agency Task Force for the Management of Emerging Infectious Diseases has directed pension agencies and their servicing financial institutions to find ways to serve seniors better. Adopting alternative modes to service senior citizens their subsidy so that they do not have to appear in person to access them should be instituted in their service policies. The senior citizens is a sector highly vulnerable to contracting infections and other diseases.

“We are in the middle of a pandemic and seniors are at high-risk and are vulnerable to COVID-19. To ensure their health and safety, this resolution is approved,” presidential spokesperson Harry Roque said via state-run People’s Television, Friday, 19 February.

Government has prohibited people older than 65 from going out of their homes, unless for emergency or humanitarian purposes, because they are at higher risk of contracting severe COVID-19 that would require hospitalization and may even lead to death. This includes persons with comorbidities.(JSM/JuanManila)

Gov’t signs indemnification deal for Pfizer, AstraZeneca

Govt signs indemnification pact with Pfizer and AstraZeneca

 

MANILA The government signs an indemnification agreement with each of vaccine manufacturers Pfizer and AstraZeneca under the COVAX facility negotiation, says National Policy Against Covid-19 chief and vaccine czar Carlito Galvez Jr.

Since the World Health Organization (WHO) has already approved the Emergency Use Listing for AstraZeneca firm, vaccine doses from said manufacturer can be deployed in the Philippines via COVAX.

 

  • “What is COVAX?
  • COVAX is one of three pillars of the Access to COVID-19 Tools (ACT) Accelerator. It is the only truly global solution to this pandemic because it is the only effort to ensure that people in all corners of the world will get access to COVID-19 vaccines once they are available, regardless of their economic standing. It was launched in April by the World Health Organization (WHO), the European Commission and France in response to this pandemic.

 

Pfizer and AstraZeneca vaccine firms have submitted applications for the Emergency Use Authorization (EUA) to the country’s Food and Drug Administration (FDA).  EUA for Pfizer vaccines under the COVAX facility has been issued; AstraZeneca’s, meanwhile, is in the process of finalizing its donations under the COVAX facility.

The Government is fully prepared for the arrival of the first batch of 117,000 vaccine doses from Pfizer, says Galvez. It is now processing the final arrangements and necessary requirements for vaccine deployment.

Moreover, all Covid-19 vaccine manufacturers require an indemnification clause agreed upon in their contracts, including non-disclosure agreement, Galvez says. However, the requirement for indemnification clauses is not limited to negotiations under the COVAX facility.

He reiterates that once the supply agreement are finalized, the disclosure of details for vaccine arrival including the vaccine’s costs, volumes, and exact delivery dates will be disclosed to the public.

“We are expecting 148 million doses of vaccines if we maintain no violations to the agreements,” he says.

The Government aims vaccinate 70 million Filipinos this year. (JSM/JuanManila)