PHL FDA issues EUA to J&J’s single-dose Janssen COVID-19 vaccine

A screenshot of the Food and Drug Administration (FDA) website showing the Emergency Use Authorization (EUA) issued to Janssen COVID-19 vaccine by Johnson and Johnson (Screenshot of FDA website/Courtesy FDA)


(Eagle News) – After careful consideration, the Philippine Food and Drug Administration issued an emergency use authorization (EUA) to the “Janssen COVID-19 Vaccine” of Johnson and Johnson on Monday, April 19.

The single dose vaccine can only be used for individuals aged 18 and above.

The FDA said that Johnson and Johnson was able to provide all the supporting documents, and these had been reviewed by local experts.

The EUA was issued amid a pause in the use of the J&J vaccine in the US after reported rare blood clots in six cases out of more than 6.8 million doses administered in the U.S.  The cases are now being investigated.

“After careful consideration of the application, with all its supporting documents and a review of local experts, the FDA has been satisfied that all the conditions for the issuance of an EUA exist as provided under Executive Order (EO) No. 121, s. 2020,” the FDA said in its letter to Johnson and Johnson granting EUA to their vaccine.

“Based on the totality of evidence available to date, including data from adequate and well- known controlled trials, it is reasonable to believe that the Janssen COVID-19 Vaccine may be effective to prevent, diagnose, or treat COVID-19,” it said.

The FDA said that “the known and potential benefits of the Janssen COVID-19 Vaccine, when used to diagnose, prevent, treat COVID-19, outweigh the known and potential risks of said Vaccine as of date.”
The Janssen COVID-19 Vaccine is supplied as a “suspension in multi-dose (5 doses) vials.”

-Single dose vaccine-

“The dosing regimen is a single dose of 0.5 mL administered as intramuscular injection. Each 0.5 mL dose of the Janssen COVID-19 Vaccine is formulated to contain 5×1010 virus particles of the Ad26 vector encoding the S glycoprotein of SARS-CoV-2,” the FDA stated in the EUA issued to the Janssen vaccine.

BUFFALO, WV – MARCH 26: A Premise Health healthcare worker loads a syringe with the Covid-19 Johnson & Johnson Janssen vaccine as part of a collaborative effort from the West Virginia National Guard, FamilyCare Health Centers and Toyota to vaccinate Toyota employees on March 26, 2021 in Buffalo, West Virginia. Stephen Zenner/Getty Images/AFP (Photo by Stephen Zenner / GETTY IMAGES NORTH AMERICA / Getty Images via AFP)

“Johnson and Johnson (Philippines), Inc. shall have a comprehensive pharmacovigilance system for Janssen COVID-19 Vaccine following system or protocol for a registered drug and biologic product as stated in the FDA Circular No. 2020-003. Submission of serious and non-serious adverse reaction reports is mandatory,” it said.

The FDA said that in the absence of an agreement with the Department of Health and the National Task Force, “Johnson and Johnson (Philippines), Inc. shall provide appropriate cold chain requirements for storage, transport and handling until it is delivered to the inoculation sites.”

The FDA said that the company should “also ensure that a contingency plan is in place.”

The government agency is also requiring the Johnson and Johnson (Philippines) Inc., to have “a system of monitoring to ensure traceability and that the vaccine is consistent with the storage requirements from the manufacture and transport to the inoculation sites.”

The vaccine can be stored in refrigerator temperature of between 2 degrees to 8 degrees Celsius.

A screenshot of the Food and Drug Administration (FDA) website showing the list of COVID-19 vaccines it had issued Emergency Use Authorization (EUA). (Screenshot of FDA website/Courtesy FDA)

-5 vaccines issued emergency use authorization so far-

With the grant of EUA to the Janssen vaccine against COVID-19, the FDA has issued a total of five EUA to COVID-19 vaccines. The first was for Pfizer, followed by AstraZeneca, Coronavac of Sinovac, and Russia’s Sputnik V vaccines.

On April 13, Johnson and Johnson issued a statement announcing a “pause in the use of our vaccine” as recommvended by the US Centers for Disease Control (CDC) and the US Food and Drug Administration as part of its precautionary measures.

“The safety and well-being of the people who use our products is our number one priority. We are aware of an extremely rare disorder involving people with blood clots in combination with low platelets in a small number of individuals who have received our COVID-19 vaccine,” it said.

It said that the US CDC and the US FDA were reviewing data involving six reported U.S. cases out of more than 6.8 million doses administered in the US.

Both the US and Europe’s drug regulator, European Medicines Agency, are expected to rule on the safety of the Johnson and Johnson COVID-19 vaccine.

The European Medicines Agency is due to hold a press conference from Amsterdam on Tuesday, after reviewing four cases — one fatal — of rare blood clots reported among people who got the J&J shot.

The US, on the other hand, is expected to make its announcement regarding the J&J shot on Friday.

(Eagle News Service with an Agence France Presse report)