Coronavirus company news summary – PFizer/BioNTech begin rolling EMA submission of Covid-19 vaccine – Moderna may seek EUA from FDA for mRNA-1273 – Indonesia grants EUA to favipiravir and remdesivir

7 October 2020 (Last Updated October 7th, 2020 10:16)

Indonesia's Food and Drug Monitoring Agency (BPOM) has granted emergency use authorisation (EUA) to the antiviral drugs favipiravir and remdesivir for the treatment of Covid-19 patients as cases in the country increased by 4,056 in a single day to 311,176. Last month, several pharmaceutical companies also obtained approvals from the BPOM to produce the drugs. The permit to produce favipiravir was issued to PT Beta Pharmacon, while PT Kimia Farma was approved to produce a generic favipiravir product.

Pfizer and BioNTech have initiated a rolling submission to the European Medicines Agency (EMA) for SARS-CoV-2 vaccine candidate BNT162b2. By working with the EMA’s Committee for Medicinal Products for Human Use (CHMP), the companies plan to complete the rolling review process to facilitate the final marketing authorisation application (MAA) for BNT162b2, which is the lead candidate from the companies’ vaccine development programme against Covid-19. The MAA submission could be finalised after the rolling review process. The EMA accepted the rolling review based on available preclinical and clinical data for the vaccine candidate.

US-based biotechnology company Moderna may seek an emergency use authorisation (EUA) from the US Food and Drug Administration (FDA) for its Covid-19 vaccine candidate after 25 November. With the EUA, the FDA can authorise the use of unapproved medical products or treatments during public health emergencies. Moderna CEO Stephane Bancel was quoted by Times Now Digital as saying: “25 November is the time we will have enough safety data to be able to put into an emergency-use authorisation file that we would send to the FDA.”

The COVID-19 Early Treatment Fund (CETF) has reported positive results of an outpatient clinical trial at Washington University in St Louis that examined the viability of selective serotonin reuptake inhibitor (SSRI) fluvoxamine in patients with mild Covid-19. Based on the trial results, it was observed that, if given early in the course of Covid-19, the drug significantly reduced the likelihood of hospitalisation. CETF founder Steve Kirsch said: “Covid-19 will be with us for a while, so in addition to the vaccine studies, we should be focusing on testing drugs such as fluvoxamine, camostat, GS-441524, and doxazosin.”