Blueprints and pledges seek to build trust in Covid vaccine

PT Jyothi Datta | Updated on September 25, 2020

Need for transparency Questions abound on the effectiveness of the vaccines under development, their duration of protection   -  Ca-ssis

Biopharma companies’ disclosures will help the public overcome ‘vaccine hesitancy’

Two international actions this month from biopharmaceutical companies involving their bouquet of Covid-19 vaccines under development are being labelled “unprecedented”.

In early September, the chiefs of nine companies pledged to “uphold the integrity of the scientific process”, as some of their vaccine candidates entered the final stretch of clinical trials before regulatory reviews are done and a stamp of approval is got for mass use. In the days that followed, four of these companies went public with “blueprints” of their vaccine candidate under development, ostensibly under pressure from scientific voices for more disclosures.

The political overtones to the pharma chiefs’ pledge are unmistakable. They pretty much indicated that a vaccine would not be rushed before the November elections in the US. But politics aside, looking at both developments through a scientific lens, it is a vote for public trust and transparency.

Regulators and Governments have pulled out all stops to fast-track the process to get a workable vaccine, at the earliest. Many governments have also put big money on the development and production of these vaccines, even committing “at risk” to buy large numbers when trials are under way.

But since public funds are involved, accountability is expected.

The bigger role, though, is on the trust front, as disclosures help shore up confidence in people to take the Covid vaccine when one is indeed available.

Robust design

Vaccine hesitancy involving the Covid vaccine stems from genuine concern over shorter trial periods and speedy regulatory processes. The adverse event reported from one participant in the AstraZeneca-Oxford University vaccine trial, for instance, still has unanswered questions. In fact, the US has not yet given its go-ahead to resume trials on this vaccine, though other regions, including the UK and India, have resumed.

Dr Chirag Trivedi, President, Indian Society for Clinical Research, agrees that data is coming in “at lightning speed” and there are still many unknowns. Results are still to come out from advanced Phase III trials of the different vaccine candidates, data will be reviewed on how much immunity they provide and for how long, when should a booster be given, etc, explains Trivedi, Sanofi’s Senior Director and Clinical study unit cluster head for India and South-East Asia.

However, he adds, the clinical trial “designs are robust”, companies have increased the number of people on late-stage trials from 30,000 to 40,000, even 60,000 in some cases, and they are more inclusive, with more diverse populations.

It is important to build trust, says Trivedi, “as people are anxious that a 15-year development process was being collapsed into 1.5 years or less. But they are also eager to have a vaccine against the virus.”

Agreeing that disclosures are a good move, he adds, “You need to give, to get their trust.”

When clinical trials are registered with regulatory authorities, their protocols, primary end-points, etc, are shared. But in sharing “blueprints”, companies give more granular details, at what point they would stop their trial and other statistical data, for example. “The product coming out of this comes from good science,” he says, adding, however, that the long-term outcome of these vaccines will still need to be watched.

Vaccine expert Dr Vipin M Vashishtha observes, that unlike the West, the Indian public largely have confidence in vaccines. But there are issues with the Covid vaccine. “We still don’t have a vaccine against SARS-COV1. (the virus causing Covid-19 is SARS-COV-2),” and questions abound on the effectiveness of these vaccines, their duration of protection, etc. Vashishtha compares the Covid vaccine’s efficacy at 50-odd per cent to measles at 95 to 97 per cent or oral polio at over 90 per cent. The dengue vaccine failed due to exacerbation of the disease. All these factors play against the Covid vaccine, he says.

Monitoring public attitudes

“It is vital with new and emerging disease threats such as the Covid-19 pandemic that we regularly monitor public attitudes to quickly identify countries and groups with declining confidence, so we can help guide where we need to build trust to optimise uptake of new life-saving vaccines”, says Professor Heidi Larson, from the London school of Hygiene & Tropical Medicine, UK, who led a research on vaccine confidence, recently published in The Lancet.

The next few months and the data coming out will play a key role in whether the average citizen feels confident to take a Covid-19 vaccine.

Published on September 25, 2020

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