FDA waiting for Moderna COVID-19 vaccine EUA; assures availability of remdesivir

During Monday's Talk to the Nation Cabinet briefing, Food and Drug Administration Director-General Dr. Eric Domingo reported that they were just waiting for Moderna to file an Emergency Use Application for their COVID-19 vaccine.

"Yun naman pong Moderna, fina-follow up po namin yung application nila," explained Domingo. "Ang sabi po kino-complete pa nila yung kanilang documents and that the local partner would submit hopefully by this week."

(We're following up on Moderna's EUA. They explained that they were just gathering the necessary documents, and their local partner would submit the application by this week.)

Given that the Moderna vaccine had EUAs in both the US and EU, the FDA could quickly assess the vaccine based on the data already gathered.

Meanwhile, Domingo also reported that stocks of the COVID-19 therapeutic drug remdesivir were being replenished after stocks were significantly diminished at the start of the surge.

"[N]agdatingan na po ang kanilang mga supplies and they reassured us  there's availability of stocks for at least one month," said Domingo. "Pero tuloy tuloy naman po ang import nila at ang mga hospital kumukuha po ng compassionate special permit diyan."

(The drug manufacturer's supplies have arrived and they reassured us that there are stocks for at least a month. Nevertheless, remdesivir is being imported continuously and hospitals are applying for compassionate special permits for its use.)

While there were sufficient stocks of the COVID-19 therapeutic drug favipiravir, there was a shortage of tocilizumab.

There was only one manufacturer for tocilizumab, nevertheless, Domingo said that supplies would be replenished during the week.

Meanwhile, Domingo emphasized that ivermectin was not part of the Health Department's treatment protocol for COVID-19.

But three companies had signified their intention to register their version of ivermectin which was fit for use on humans.

The companies were given a list of requirements, and once these were submitted, the FDA would evaluate the drug.  — DVM, GMA News