Three Firms Announce COVID-19 Vaccine Trials
Moderna, BioNtech/Pfizer and J&J moving ahead
The race to have a COVID-19 vaccine available for clinical trials is rapidly heating up. In the first three days of this week, two US companies and a German biotech in cooperation with a US company have announced they have a candidate, and one already has given a dose to its first patient.
In its Phase 1 trial just kicked off, Moderna plans to enroll 45 healthy adults over a six-week timeframe, with each participant receiving two injections about a month apart in varying doses.
The first phase will try to establish that the vaccine is safe and that it induces a desired response from participants' immune systems. The second phase, which will seek to prove that the vaccine can successful prevent COVID-19 infection, will require months-long follow-up studies involving many more participants.
Moderna’s messenger RNA (mRNA) vaccine candidate was developed in conjunction with the US National Institute of Allergy and Infectious Diseases (NIAID), which is funding the trials run by the Kaiser Permanente Washington Health Research Institute in Seattle.
NIAID the trials could be started quickly, thanks to prior studies on related coronaviruses SARS and MERS. Some vaccines in development for other areas are already being tested against the virus, the agency said.
Two of Moderna’s competitors, BioNtech and healthcare giant Johnson & Johnson, also are not sleeping.
BioNTech extends pact with Pfizer
In cooperation with US drugs giant Pfizer, Germany's BioNTech aims to use its drug development platform to develop a COVID-19 vaccine. In a joint statement, the companies – which have signed a letter of intent for the vaccine's distribution outside China – said they will start work immediately.
Financial terms, manufacturing and possible commercialization options are planned to be worked out over the next few weeks. Research and development will be conducted both in the US and Germany. The two companies already are working together to develop mRNA-based vaccines for influenza.
On Mar.16, BioNtech also signed a deal with Shanghai Fosun Pharmaceutical, outlining rights to its experimental vaccine in China.
The partners aim to start human trials from late April.
J&J aiming to start trials In November
Johnson & Johnson said it plans to designate a COVID-19 vaccine candidate by the end of March with an eye to starting clinical trials in early November.
As it moves into preclinical work and then the trials, J&J’s chief scientific officer, Paul Stoffels, told business broadcaster CNBC the US group will set up processes for widespread production of the vaccine, “in order to have large quantities available early next year.”
Development work will be based on the same vaccine platform used to develop the group’s Ebola vaccine, which will allow it to “go very fast and with very good information,” Stoffels said.
In late January, J&J started work on a COVID-19 vaccine and extended its alliance with the US Biomedical Advanced Research and Development Authority (BARDA), part of the Department of Health and Human Services. Its Janssen unit and the US authority plan to co-fund R&D on the vaccine, and both will make their resources available.
Sanofi Pasteur, the vaccines global business unit of French drugmaker Sanofi is also collaborating with BARDA on finding a COVID-19 vaccine.