DUBLIN – Last May, a quartet of Dutch biotech industry veterans gathered for a socially distanced outdoor meeting in a private garden in Leiden to discuss what could be done to prevent the present COVID-19 fiasco from ever occurring on such a scale again. A new startup, Leyden Laboratories BV, emerged from that conversation, and it has just raised €40 million (US$47.3 million) in a series A round to develop broad-spectrum, self-administered, intranasal antiviral drugs to prevent infection.
The continuing politicization of COVID-19 vaccines is undermining medical science and the international response to the pandemic. “Vaccine nationalism is very troubling,” Jeremy Levin, chair of the Biotechnology Innovation Organization’s (BIO) executive committee, told BioWorld.
Now that Johnson & Johnson (J&J), through its Janssen Pharmaceuticals unit, has won the FDA’s nod for Ponvory (ponesimod), market factors will decide how the once-daily oral selective sphingosine-1-phosphate receptor 1 modulator fares against several others already approved in the class.
While World Trade Organization members continue to debate a proposal to waive intellectual property rights for COVID-19 vaccines and therapies, Biolyse Pharma Corp. is threatening to apply for a compulsory license of Johnson & Johnson’s one-dose vaccine through the Canadian Access to Medicines Regime.
With COVID-19 vaccine manufacturing still scaling up and the scarcity of some supplies, most of the vaccine doses available so far have been distributed in 75 countries while 115 countries are still waiting, World Trade Organization (WTO) Director-General Ngozi Okonjo-Iweala said at the March 9 Global C19 Vaccine Supply Chain and Manufacturing Summit.
As the World Trade Organization (WTO) debate intensified this week over a demand to waive patent protections for COVID-19 vaccines and therapies, the group’s new director-general, Ngozi Okonjo-Iweala, urged members to “walk and chew gum” at the same time by working with “companies to open up and license more viable manufacturing sites now in emerging markets and developing countries. We must get them to work with us on know-how and technology transfer now.”
As the World Trade Organization (WTO) debate intensified this week over a demand to waive patent protections for COVID-19 vaccines and therapies, the group’s new director-general, Ngozi Okonjo-Iweala, urged members to “walk and chew gum” at the same time by working with “companies to open up and license more viable manufacturing sites now in emerging markets and developing countries. We must get them to work with us on know-how and technology transfer now.”
Months of talks between Johnson & Johnson (J&J) and Merck & Co. Inc. about a COVID-19 vaccine manufacturing partnership came to fruition March 2 with the Biden administration hailing the deal as an “unprecedented historic” agreement between two long-time rivals.
With the FDA’s granting of emergency use authorization (EUA) to Johnson & Johnson (J&J), there is now a third vaccine – and the first requiring only a single shot – against COVID-19 for adult Americans. Though it packs less of an efficacy punch, the EUA allows J&J’s Ad26.COV2.S to join mRNA vaccines from Moderna Inc. and Pfizer Inc./Biontech SE as protection against the virus.
As expected, the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) looked favorably upon the latest COVID-19 entry: Ad26.COV2.S, a one-shot product that emerged from the same Johnson & Johnson (J&J) platform, AdVac, that let the firm devise an Ebola vaccine cleared in Europe last year.
