Pfizer’s EUA stays amid death probe

For now, while there is still no sufficient evidence to say that (the deaths) are really caused by the vaccine, the EUA we had granted to Pfizer remains

The emergency use authorization (EUA) issued by the Food and Drug Administration (FDA) to PfizerBioNTech’s Covid-19 vaccine will remain amid investigation that it caused the deaths of some 29 elders in Norway, the Department of Health (DoH) said Monday.

Health Undersecretary Maria Rosario Vergeire said the country’s FDA will evaluate Pfizer-BioNTech’s report regarding the incident.

“For now, while there is still no sufficient evidence to say that (the deaths) are really caused by the vaccine, the EUA we had granted to Pfizer remains,” Vergeire told reporters in a press conference.

Vaccine czar Carlito Galvez Jr. previously said the Philippines will be more cautious in picking

Covid-19 vaccines that will be administered to the elderly to avoid a similar incident once the state’s vaccination program begins.

Following this development, FDA director general Eric Domingo said the state regulatory board can indicate in the EUA that the product cannot be given to the elderly and those with severe allergies.

An EUA allows the use of a vaccine that is still under development during a public health emergency.

“Before we can use that vaccine, we will add in the list of contraindications that it cannot be used for people with severe allergies and possibly to those who are really old,” Domingo said in an interview Sunday.

Norway has expressed concern on the safety of Pfizer’s coronavirus vaccine on elderly people with serious underlying medical conditions, suggesting its doses may be too risky for vulnerable patients.

All the deaths occurred among patients in nursing homes who were over the age of 80 and with underlying conditions, the Norwegian Medicines Agency reported.

An EUA allows the use of a vaccine that is still under development during a public health emergency.

Pfizer, for its part, said it was working with the Norwegian regulator to investigate the deaths in the country.

In Malacañang, presidential spokesperson Harry Roque expressed hopes that the reported deaths of at least 20 elders in Norway days will not affect its EUA in the Philippines, citing the importance of giving Filipinos protection from Covid-19.

He also noted that vaccines cannot claim to have 100 percent safety and efficacy.

“I hope it won’t affect (the EUA) because it is important to protect our citizens from the disease,” Roque said in GMA-7’s morning news program.

At press time, Pfizer-BioNTech’s vaccine, which touts a 95 percent efficacy rate, has the sole EUA in the Philippines.

Other firms such as China’s Sinovac, United Kingdom’s AstraZeneca, and Russia’s Gamaleya have pending applications for EUA.

Pfizer has developed messenger RNA (mRNA) vaccines, a cutting-edge technology which has never been approved by the FDA before the Covid-19 pandemic.

The vaccine carries mRNA or the molecule that cells naturally use to carry DNA’s instructions to cells’ protein-building machinery.

Most traditional vaccines consist of either killed or weakened forms of a virus or bacterium, which provoke an immune response that allows the body to fight off the actual pathogen later on.

Instead of delivering a virus or a viral protein, mRNA vaccines deliver genetic information that allows the body’s own cells to produce a viral protein, which stimulates the immune system to mount a response, without posing any risk of infection.