Johnson & Johnson announced Monday that it had become the second company to halt its trials on a COVID-19 vaccine due to an “unexplained illness” affecting a trial participant.
We have temporarily paused further dosing in all our COVID-19 vaccine candidate clinical trials, including the Phase 3 ENSEMBLE trial, due to an unexplained illness in a study participant. Following our guidelines, the participant’s illness is being reviewed and evaluated by the ENSEMBLE independent Data Safety Monitoring Board (DSMB) as well as our internal clinical and safety physicians. per Johnson & Johnson.
Why it matters: Covid-19 has changed how we live in the world. Many scientists believe that for life to come back to “normalcy” we will need a certain level of herd immunity.
For a vaccine program to be effective against a common pathogen, a certain percentage of the population usually needs to be inoculated and able to resist infection.
A high level of participation helps create what is called “herd immunity,” which is often necessary to safeguard those who don’t respond well to the vaccine, says Rob Kozak, a clinical microbiologist at Sunnybrook Health Sciences Centre in Toronto.
Clinical trial stages for Vaccines
- Phase I. The drug is given to a small number of healthy people and people with a disease to look for side effects and figure out the best dose.
- Phase II. The drug is given to several hundred people who have the disease, looking to see whether it works and if there are any side effects that weren’t caught during the initial testing.
- Phase III. In this large-scale trial, the drug is given to several hundred or even up to 3,000 people. A similar group of people take a placebo, or inactive compound. The trial is usually randomized and can take 1 to 4 years. This stage provides the best evidence of how the drug works and the most common side effects.
- Phase IV. Drugs that are approved for use undergo continued monitoring to make sure there are no other side effects, especially serious or long-term ones.
Covid-19 Trials that Have been stopped:
- Oxford University has announced that final-stage testing of a coronavirus vaccine it is developing with drug maker AstraZeneca will restart following a pause last week after a serious side effect showed up in a volunteer.
Covid-19 Vaccines By the numbers: There are more than 100 projects centered around Covid-19 vaccines. Experts say the likely timeline for distribution of a vaccine is summer or fall 2021. The World Health Organization said in early September that a vaccine would not be available until mid-2021.
- Scientists at CanSino Biologics in China are also working on a potential vaccine. In late July, they reported that participants in a phase II trial showed a strong immune response when given the vaccine. However, they noted older adults had a weaker response, suggesting two doses might be needed for that segment of the population.
- University of Queensland in Australia. Researchers are developing a vaccine by growing viral proteins in cell cultures. They began preclinical testing stages in early April. The phase I trial in people will begin in early July.
- Moderna. In March, the company began testing its messenger RNA (mRNA) vaccine in a phase I clinical trial in Seattle, Washington. In mid-May, the company announced the vaccine had produced antibodies in all 45 trial participants in this initial clinical phase. The study included 45 healthy volunteers, ages 18 to 55, who are getting two shots 28 days apart.
Trends to Watch: There are currently tens of vaccines worldwide and hundreds more being tested. In what is considered the biggest search for a vaccine in modern history.
- Mexico makes $159 million payment to the World Health Organisation Covax system for Covid-19 vaccine. Mexico’s foreign ministry said that the government had presented the “risk guarantee” paperwork for another $20.6m, which it described as part of the contractually required commitments to access the eventual vaccine supply.
- China joins COVAX to help source and fund vaccines especially in third world countries. The COVID-19 Vaccines Global Access Facility (COVAX) is led by the World Health Organization (WHO), the Coalition for Epidemic Preparedness Innovations (CEPI) and Gavi, the Vaccine Alliance and aims to deliver some two billion doses of vaccine around the world by the end of next year.
Covid-19 Vaccine News in Africa
- Oxford University-developed vaccine to be tested in Kenya. The trials to be carried out by the Kenya Medical Research Institute (Kemri) will recruit 400 health workers in Kilifi and Mombasa counties.
- Kenyans to Benefit from Covid-19 Vaccine at ksh. 300 by 2021. Bill & Melinda Gates foundation to reduce the cost of Covid-19 vaccines to $3 per person
- On Aug 17, 2020, screening began for participants to enrol in the mid-stage study of an experimental COVID-19 vaccine by Novavax, a US drug developer of next-generation vaccines for serious infectious diseases, at Witwatersrand University (Wits) in Johannesburg, South Africa. A US$15 million grant towards the trial was awarded to Novavax by the Bill & Melinda Gates Foundation. 2665 healthy adults and nearly 240 medically stable, HIV-positive adults will be enrolled.
The bottom line: There is an urgency to find the Covid-19 cure or vaccine. Polio may be last time pharma companies worked towards a global solution as they have. However, with the politics involved, one wonders if they are not rushing to please political whims.