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Janssen seeks FDA nod for its single-shot vax

  • Sinovac data critical to EUA for the elderly
  • Antigen test okayed
American drugmaker Johnson & Johnson’s pharmaceutical arm Janssen applied for emergency use authorization (EUA) of its single-dose COVID-19 vaccine, the Food and Drug Administration said Monday.

“[They filed] last Wednesday. Now under evaluation,” FDA chief Eric Domingo told GMA News Online.

Janssen’s Phase 3 clinical trial for its COVID-19 vaccine is currently underway in several areas across the Philippines.

Janssen’s vaccine showed 66 percent efficacy in preventing COVID-19 in a large global trial against several coronavirus variants.

It is also 85 percent effective against severe COVID-19 and prevents hospitalization 28 days after immunization.

Meanwhile, the Department of Health said it was still waiting for China-based Sinovac’s clinical trial data showing that its COVID-19 vaccine was safe to use on senior citizens. This, after the Philippines' stockpile of AstraZeneca jabs ran out.

In late February, a Sinovac official claimed their vaccine could be used by health workers and senior citizens. Philippine officials heading the COVID-19 response also said they wanted to use the vaccine for the elderly since anecdotally there were limited side effects.

However, the FDA said last month it would only change the details of the emergency use authorization for Sinovac once it receives evidence on the trial results.

The Philippines has only received 2.5 million COVID-19 vaccine doses with only 525,000 coming from AstraZeneca and the rest from Sinovac.

Only AstraZeneca has been approved for elderly use based on the emergency use authorization issued by the FDA. This is due to the clinical trials done by the Europe-based company on elderly patients. 

Of the 2.5 million doses received, almost 1.5 million have already been distributed. Of this number, only 740,000 had been administered.

The government plans to inoculate 70 million Filipinos by the end of the year to reach herd immunity but it has been criticized for the slow rollout of vaccines.

Until now, it has yet to reach the estimated 1.8 million health workers although it has allowed simultaneous vaccination of senior citizens and people with comorbidities to speed up the process.

At the same time, the Department of Health tapped medical cold chain firm Pharmaserv Express, one of its private partners, for the distribution of COVID-19 vaccines in the Visayas and Mindanao regions.

In a statement, Pharmaserv Express said it was responsible for the delivery and distribution of the first batch of 1.5 million vaccines to critical areas in the country for the inoculation of health care workers.

The 1.5 million vaccines were composed of a million donated doses from China’s Sinovac and 500,000 from AstraZeneca through the World Health Organization’s COVAX facility.

“So far, Pharmaserv has delivered more than 1.5 million vaccines (all the initial doses) across the country, including in the Visayas and Mindanao regions for the vaccination of thousands of health workers and front liners for the past three months,” the company stated.

Pharmaserv Express has been working with the DOH for several years now to distribute routine vaccines across the country.

With the arrival of one million COVID-19 vaccines purchased by the Philippine government from Chinese-owned company Sinovac last March 29, it has become even more critical for the Health department to find a partner that can efficiently distribute the vaccines to far-flung areas.

But while “it has worked with different agencies of the United Nations (UN), pharma companies and local government units,” Pharmaserv Express said that “the enormous task at hand (of distributing the COVID-19 vaccines) would be the most challenging” because of “the urgency of the current situation.”

The DOH has picked Pharmaserv as one of its logistics partners for vaccine distribution due to its vast expertise and experience in handling biothermals such as vaccines and blood products that are grounded on latest technology, operations protocols and workflows, manpower complement, and overall capabilities.

This is in compliance to the “stringent requirements of moving temperature-critical products” such as vaccines.

At the moment, the Philippines has access to only two brands of COVID-19 vaccines—Sinovac and AstraZeneca. Both of these can be stored in a standard refrigerator at 2 to 8 degrees Celsius. They are unlike the more efficient Pfizer-BioNTech and Moderna vaccines, which need to be stored in minus 20 degrees Celsius.

In related developments, the DOH said rapid antigen tests could now be used as diagnostic and confirmatory for COVID-19 cases, but persons having a negative result would still undergo confirmatory tests using the Reverse Transcription-Polymerase Chain Reaction (RT-PCR) testing.

“Pursuant to the Inter-Agency Task Force on Emerging Infectious Diseases Resolution No. 106-Authorizing the procurement and use of Rapid Antigen Test Kits in accordance with Department of Health (DOH) Department Memorandum (D.M.) 2020-0468 which provides technical guidance on the use of antigen tests, the DOH shall allow the use of rapid antigen as diagnostic and confirmatory tests for close contacts, and COVID-19 suspect and probable cases in the NCR+ area (Bulacan, Cavite, Laguna, Rizal, and Metro Manila), without the need for Reverse Transcription-Polymerase Chain Reaction (RT-PCR) testing,” the DOH said in a statement on Monday.

“This is to ensure that the appropriate response and control measures may be immediately initiated by Local Government Units to contain further spread of the virus,” the DOH said.

In accordance with existing guidelines, while a positive rapid antigen test result is considered a confirmatory test for COVID-19 suspect and probable cases and close contacts, those with a negative result will be subject to a confirmatory RT-PCR test or a repeat antigen test after 48 hours, the DOH said.

The DOH, however, emphasized that RT-PCR testing remains to be the gold standard for confirming the presence of SARS-CoV-2 and that the use of rapid antigen tests as confirmatory tests shall only be allowed until the declaration of outbreak in the NCR+ area has been lifted.

Moreover, antigen testing shall not be used for border control, pre-travel testing, workplace screening, or testing of asymptomatic general contacts.

Additionally, only qualified licensed healthcare professionals in local health offices, health facilities, accredited quarantine and isolation facilities, and certified COVID-19 confirmatory laboratory facilities are authorized to administer rapid antigen tests and interpret its results.

Further, rapid antigen test kits to be administered should be registered with the FDA, and validated by the Research Institute for Tropical Medicine (RITM) or other designated institutions.

Considering this development, the DOH shall also include suspect and probable cases and close contacts with positive rapid antigen tests from areas with declared outbreaks—in this case the NCR Plus area—as confirmed in the daily case count, as well as in the total case count being reported by the Department.

However, reporting of COVID-19 cases shall be disaggregated based on the type of test used.

Those cases who tested positive but do not fit the case definition of suspect and probable case or close contact under existing DOH issuances shall be retested using RT-PCR for them to be tagged as a confirmed COVID-19 case, the DOH also said.

Topics: Johnson & Johnson , Janssen , emergency use authorization , COVID-19 vaccine
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