Covid Vaccine Development

SOUTHAMPTON MEDICAL SOCIETY

President: Dr Alan Roberts FRCP

A meeting of the Southampton Medical Society was held on Zoom on the 2nd of March 2022. In the absence of the President, Dr Alex Freeman took the chair. The minutes of the previous meeting were approved: Proposed by John Dracass and seconded by David Rowen.

Dr Freeman then introduced our speaker Professor Saul Faust of Southampton University who spoke to the title “ Covid Vaccine Development”.

In January 2020 there were pictures appearing on social media of severely ill Chinese in Wuhan with a new virus. Researchers at Oxford University had already identified the virus, which had similarities to SARS1 and MERS with a spike protein, and started developing a vaccine. Astra Zeneca was not involved at this time. It was yet to be discovered if a vaccine could produce antibodies against the spike protein and also produce a cellular response. They needed to know if it was safe, if it would protect against infection, if there was a risk of enhanced disease and how long the protection would last. Would boosters be needed? Normally the development process takes one to two years before trials are started. On 12th March 2020 Saul said he was approached by the HPA to help set up a phase 1 trial - the first site outside Oxford.  The number of centres was increased to 5, involving 1,077 participants at this stage. By the end of May there were 20 sites and 10,812 volunteers. Saul borrowed the Southampton University sports hall, recruited 67 staff who would be involved in actively monitoring the volunteers.The subjects were swabbed every time they got any symptoms and had to be reviewed in a safe manner by the staff in case the volunteers had Covid. The first volunteer was injected in April 2020. Astra Zeneca ran the Oxford trial. At this point the UK government set up the Vaccine Task Force under Kate Bingham which consisted of scientists and business people with a remit to survey the different vaccines worldwide and invest in different technologies to ascertain which might work. They put a lot of money into a vast number of trials. A National Network was set up for vaccine delivery which would involve more than 100 centres and recruit more volunteers and train more staff. The vaccines surveyed were produced by Astra Zeneca, Imperial College, Novavax, J&J Janssen, Valneva, Medicago and GSK.  Six new trials were launched in 2021. In 2022 Pfizer and Moderna vaccines were added for further assessment in the UK. Sanofi and Moderna are also testing a vaccine against the Omicron variants. Different dose regimes were looked at including spacing between doses to find out which was most efficient. There was not enough information concerning immunocompromised patients. The National Immunisation Schedule Evaluation Consortium looked at mix and match schedules, concomitant influenza and Covid vaccination, choice of 3rd dose vaccine and the 3 month interval [which showed a maximum antibody response by day 7]. Southampton is running the 3rd dose booster study in 35 sites tracking the longevity of immune responses and the need for a 4th dose. They are also at present involved in live viral challenge trials in which young healthy participants with no Covid risk factors who have been fully vaccinated are given Covid 19. Janssen is now restarting work on its viral vector vaccines.

How to accelerate vaccine development is important and UK trials are looking at comparing preclinical and actual trial data, immuno-responses and efficacy, ongoing need and risk for clinical trials of different vaccines. Internationally Professor Faust considered the FDA has behaved very badly and what is despicable is that it has still not recognised the AZ vaccine. At the G7 in Cornwall the EU blocked any agreement on vaccines. The Oxford vaccine has now made 2 billion doses, and is being produced in 15 countries, of which 2/3rds are going to low income countries. Three doses of the Oxford vaccine are, longterm, just as good as 2 doses of Oxford and one of Pfizer.

In all there were 47,646 participants, 25 studies and 123 sites. Important side effects recorded were blood clots with AZ and Janssen vaccines which were rare and an  extremely rare myocarditis. Because of these side effects trials on pregnant women were stopped which resulted in pregnant women not wanting the vaccine and there not being enough information. The UK government were very poor at communicating what was happening. The University of Cambridge put out on social media a comparison of the chances of side effects from the vaccine versus the Covid infection.

Professor Faust said that the MHRA were unbelievably good. This hugely benefitted the research th UK which was not always the case with research in other countries. Ethics committees were excellent as well - very approachable and prompt in their replies. He expressed his thanks to everyone involved in the Covid vaccine development.But what can we do to improve communication with the government?

The media chose not to highlight the needs of children.

Astra Zenica do not deserve the bad press they have received. They have done more than enough.

The global roll out on the whole has been very good. The problem is getting the vaccine into people rather than the supply. The sell by date is a problem and a million out dated doses have been dumped.

Concerning antivaxers one is unable to do anything but one can cure vaccine hesitancy.

Dr Freeman thanked the speaker very much for a marvellous talk and said she looked forward to following his work.