Summary of this week’s international SOS findings on the development of COVID immunity and vaccine development:
MODERNA VACCINE SHOWS PROMISING RESULTS IN ELDERLY PATIENTS IN SMALL TRIAL
Immunity in older patients
- Older patients developed similar antibody and T-cell responses to younger patients
- All age groups develop similar neutralising antibody levels to convalescent sera from recovered patients
Dr Doug Quarry, “The results go some way to reducing our concern that “immuno-senescence” – the concept that the immune system becomes less functional with age – will affect vaccines against coronavirus.”
FDA RELEASING HIGHER STANDARDS FOR EUA VACCINE APPROVAL
The Washington Post reports that the FDA (US Food and Drug Administration) will soon release more stringent standard for Emergency Use Authorisation of coronavirus vaccines.
The requirements will include:
- The vaccine needs to be 50% more effective than placebo (prevent 50%of infections)
- The company must follow participants for a median of at least two months from when they receive their second dose of vaccine
- There must be documentation of at least five severe cases of COVID-19 in the placebo group for each trial
- There must be documentation of some cases of the disease in older people
This is a very welcome development which will help to alleviate a growing perception that vaccines may have been approved without sufficient oversight by the FDA.
JOHNSON & JOHNSON START PHASE 3 TRIALS OF SINGLE DOSE VACCINE
Advantages of this vaccine
- One shot
- Only needs refrigeration, not deep freeze
- Already being stockpiled
Phase 1 & 2a results
In a public statement on 23 September 2020, Johnson and Johnson said that the Phase 1 and 2a trials demonstrated a safety profile and immunogenicity supportive of further development. The results have been submitted to MedRix and will be published imminently.
The Washington Post reported that the company’s Chief Medical Officer, Dr Paul Stoffels, said that the vaccine triggered a promising immune response and that side effects of the vaccine were tolerable, including some fevers that resolved within one to two days.
Phase 3 trials
The Phase 3 trials will enroll 60,000 volunteers in the US, South Africa, Argentina, Brazil, Chile, Colombia, Mexico and Peru. The company released its study protocol as have other companies recently.
“The Company aims to achieve representation of populations that have been disproportionately impacted by the pandemic in the implementation of its COVID-19 Phase 3 trial program. In the U.S., this includes significant representation of Black, Hispanic/Latin, American Indian and Alaskan Native participants.”
The Washington Post reported that Dr Stoffels predicted that there may be enough data to have efficacy results by the end of the year. It reported Dr Anthony Fauci saying that once there were 154 cases of COVID-19 in the trial, it would be possible to tell whether the vaccine was effective.
The Phase 3 trials started on Monday, 21 September.
Vaccine details
The vaccine was developed by Janssen, a subsidiary of Johnson and Johnson, and uses the same platform as in their Ebola vaccine and their Zika, RSV and HIV vaccine candidates.
The platform uses Adenovirus 26 as a vector for the coronavirus spike protein. This vector is also used in the coronavirus vaccine from the Russian Gamaleya Institute.
The vaccine will be shipped frozen but can be stored in liquid form at refrigerator temperatures for three months.
Vaccine supply
Johnson and Johnson states that it remains on track to be able to supply one billion doses of vaccine per year with some supply available in 2020.
The New York Times reported that Dr Stoeffels said on 23 September 2020 that the company had begun manufacturing the vaccine on an industrial scale to build up a supply that can be released immediately the vaccine is authorized. He expected to have tens of millions of doses ready by the end of 2020. “We can then ramp up to many more batches”, he said.
US Government investment
The New York Times states that the US Government’s Operation Warp Speed Program has invested about $1.5 billion in the Johnson and Johnson vaccine development. To date, the program has invested over $10 billion in private companies’ coronavirus vaccines.
Other vaccines soon for Phase 3 trials
The Sanofi and Novavax vaccine candidates are likely to start Phase 3 trials soon.
THE COVAX PROGRAM
“NO ONE IS SAFE UNTIL EVERYONE IS SAFE” – WHO
What is the COVAX program?
- It is a WHO-supported program to provide poorer countries with equitable access to COVID-19 vaccines
- It is supporting nine manufacturers to develop and manufacture COVID-19 vaccine
- The 156 nations now committed to COVAX represent about two-thirds of the world’s population
Main principles
· COVAX is a WHO plan in conjunction with CEPI* and GAVI** to support the development and equitable distribution of two billion doses of COVID-19 vaccine before the end of 2021.
· The pooled funding will allow poorer countries to access COVID-19 vaccines they would otherwise have been unlikely to afford.
Supporting vaccine development and manufacture
· CEPI* is leading COVAX research and development and aims to have at least three safe and effective vaccines available for participating countries
· Nine candidates, incorporating a range of technologies and scientific approaches, are currently being supported. These include: Oxford/AstraZeneca, Moderna, University of Queensland/CSL and Clover/GSK. This spreads the risk across vaccine candidates in case some are unsuccessful
· Some of the funding is for vaccine development and some to create a manufacturing capability
Funding
· The program will use funding from 64 higher-income countries to secure vaccine to be shared with 92 lower- and lower-middle-income countries
· Countries were asked to make a binding commitment to participate by 18 September 2020, and to provide funds by early October. These funds will allow COVAX to finalise advance purchase agreements with vaccine manufacturers
· There will be a global coordinated rollout by the WHO from Geneva
Who should get the vaccine first?
The idea is to rapidly vaccinate health-care workers, the elderly, and others at high risk in all countries. On average, this comprises about 20% of a country’s population.
Opting out and bilateral agreements
- The Russia, US and China are not participating in COVAX
- Some countries and regions (including Australia, Canada, US, Japan, and the EU) have bilateral agreements with vaccine manufacturers and all but the US have joined COVAX. This is seen to give them the greatest number of vaccine options
- France is providing funds but will not take supplies from COVAX. France will obtain vaccine via the European Joint Procurement program which has deals with AstraZeneca, and is in talks with Johnson & Johnson, Sanofi, Moderna, and CureVac
*CEPI: The Coalition for Epidemic Preparedness Innovations: a foundation that takes donations from public, private, philanthropic, and civil society organisations, to finance independent research projects to develop vaccines against emerging infectious diseases.
**GAVI: Vaccine Alliance of Governments and Organisations: set up by the Gates Foundation in 1999, with an aim to accelerate access of developing countries to vaccines and support research into health solutions for these countries that are effective, affordable and sustainable.
DR DOUG QUARRY, Group Medical Director, Health Intelligence, internationalsos.com
