CHMP Issues Positive Opinion of Pfizer’s COVID-19 Treatment

February 07, 2022 - The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recently issued a positive opinion of Pfizer’s COVID-19 treatment, Paxlovid.

The CHMP recommended conditional marketing authorization (CMA) of Paxlovid to treat COVID-19 in adults who do not require supplemental oxygen and are at an increased risk of progressing to severe disease.

“This expression of confidence in PAXLOVID comes at a critical moment as Europe addresses the ongoing challenges of the pandemic and as infection rates are on the rise in many countries across the globe,” Albert Bourla, chairman and CEO of Pfizer, said in the announcement.

“We are proud to have a strong manufacturing footprint in Europe, which will help support the production of up to 120 million courses of PAXLOVID globally,” Bourla continued.

The CHMP based its opinion on results from the Phase 2/3 EPIC-HR trial. The trial enrolled hospitalized adults 18 years of age and older with confirmed COVID-19 at an increased risk of progressing to severe illness.

The data showed that Paxlovid reduced the risk of hospitalization or death by 89 percent within three days of symptom onset and 88 percent within five days of symptom onset compared to placebo.

Notably, there were no deaths observed in the treatment group.

Currently, Paxlovid is approved or authorized for emergency use in over ten10 countries across the globe. Pfizer will continue working with EU member state governments to ensure Paxlovid is made available to patients across the country as quickly as possible.

Novavax, Israel Enter Agreement for Supply of COVID-19 Vaccine

Novavax and Israel’s Ministry of Health recently entered into an agreement for the purchase of Novavax’s COVID-19 vaccine, NVX-CoV2373.

Under the terms of the agreement, Novavax will provide an initial five million doses of its recombinant nanoparticle protein-based COVID-19 vaccine candidate, with an option for Israel to purchase an additional five million doses.

The company will work with the Ministry of Health to obtain the necessary authorizations and finalize plans for distribution in Israel, pending regulatory approval.

“Israel has been at the forefront of the fight against COVID-19 and has demonstrated strong leadership throughout the pandemic,” Stanley C. Erck, president and chief executive officer of Novavax, said in the announcement.

“We thank the Israeli Ministry of Health for their commitment to providing a protein-based COVID-19 vaccine option, based on well-understood technology, to the people of Israel,” Erck continued.

Currently, Novavax is conducting two pivotal Phase 3 clinical trials, PREVENT-19, which enrolled 30,000 participants in the US and Mexico, and a trial with almost 15,000 participants in the UK.

The vaccine demonstrated high efficacy and a reassuring safety profile in both trials.

Daiichi Sankyo Initiates Trial for COVID-19 Vaccine Booster in Japan

Daiichi Sankyo recently initiated a trial in Japan to investigate a booster dose of its mRNA COVID-19 vaccine in healthy adults, including an elderly population.

Researchers will study the booster dose of DS-5670 in adults who completed initial vaccination against COVID-19 at least six months prior. 

The first part of the study will determine the recommended booster dose of the vaccine, followed by a controlled study in 4,500 adults comparing DS-6570 to other vaccines approved in Japan.

The current rapid spread of the Omicron variant has imposed an urgent need to develop a booster vaccination program in countries globally.

DS-5670 is an mRNA vaccine using a novel nucleic acid delivery technology. So far, the vaccine induced neutralizing activities against the Omicron variant in animal models.

Daiichi Sankyo stated that it hopes to pursue the development and commercialization of DS-5670 in Japan during 2022.