Speed, safety, fairness key for vaccine: WHO regional director

“Vaccine Nationalism” must not stop equitable access to a vaccine against the coronavirus disease (Covid-19) when it is eventually discovered, international experts said at an Indian Council of Medical Research (ICMR) conference on novel ideas in science and the ethics of vaccines against the pandemic.India, with its vaccine manufacturing capability, would play an important role in access to a vaccine once it becomes available, US infectious disease expert Dr Antony Fauci said at the event via video conferencingon July 30. Dr Peter Piot, director of the London School of Hygiene and Tropical Medicine, stressed the need to make vaccines both accessible and acceptable to the people.

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Dr Poonam Khetralpal Singh, the World Health Organisation’s regional director for South-East Asia, said in an interview with Anonna Dutt that governments, health agencies and civil society must work together to ensure those who need it the most get vaccinated on a priority basis, irrespective of their nationality, where they live, their education levels, socioeconomic status, or gender. Edited excerpts from the interview:

When do you expect the first vaccines to become available?

Traditionally, it takes 5-10 years, or even more, for a new vaccine to be developed before it can be used in humans. In view of the ongoing Covid-19 pandemic which continues to affect millions of people across the world, timelines are being compressed to develop a vaccine as soon as possible.

However, despite accelerated efforts, the availability of Covid-19 vaccines would depend on the outcome of the clinical trials that are still ongoing. While several candidate vaccines are progressing to phase III trials, it cannot be said with certainty what the results of these trials will be – both in terms of efficacy and safety – and by when we will have a vaccine available for use in populations.

Once developed, a Covid-19 vaccine must be considered a global public good that can be accessed by all of humanity. To facilitate this, WHO co-launched the Access to Covid-19 Tools Accelerator and is supporting the COVAX Facility. Both these mechanisms are expected to help low- and middle-income countries gain rapid and equitable access to safe and effective vaccines.

Speed, safety and fairness are the key principles that should be followed for Covid-19 vaccines.

Will the speed of vaccine development affect acceptability? How can governments increase confidence in the vaccine?

The confidence and trust in the vaccine will be critical. The speed of vaccine development should not affect community trust if scientific and ethical standards are applied during the development of the vaccine.

To increase confidence in the potential vaccines, a transparent communication strategy on the efficacy and safety of the vaccine will be critical and addressing concerns of the people will be equally important. We have lessons from other vaccination programmes such as polio that can be emulated for increasing acceptability of Covid-19 vaccines.

The regulatory authorities will play an important role in building confidence in the vaccine by ensuring that licensure of these vaccines is based on standards laid down for this purpose. Post-marketing surveillance to assess any adverse events would further help enhance confidence in the vaccine.

In the past – as with the H1N1 pandemic – the vaccine was available after the peak of the disease was over. How have things been done differently now?

The speed of Covid-19 vaccine development has been extraordinary. Work on developing vaccines began as soon as Chinese scientists published the sequence on 11 January. First phase 1 trial started 8-10 weeks after that. WHO has been involved in R&D {research and development} efforts since January 2020.

Currently, over 165 candidate vaccines are at some stage of development. Of these, about 26 vaccine candidates are in human trial. We know of at least 3-4 going into phase III. AstraZeneca/Oxford, Moderna and CanSino are in or starting phase III; we also understand that a Russian candidate vaccine is entering this phase. There are several others currently in phase I/II, which will enter phase III in the coming two months.

We have a very robust pipeline – the more candidates, the more opportunities for success.

Should controlled human infection model studies be allowed to speed up human trials for Covid-19 vaccines?

There are benefits and risks associated with controlled human infection studies or “human challenge studies”. However, these studies can be particularly valuable for testing vaccines and can help provide (preliminary) estimates of efficacy and safety.

Such studies can be used to compare the efficacy of multiple vaccine candidates and thus select the most promising vaccines for larger studies. Well-designed challenge studies might thus not only accelerate Covid-19 vaccine development, but also make it more likely that the vaccines ultimately deployed are more effective.

Challenge studies are also used to study infection and immunity. Such findings could significantly improve the overall public health response to the pandemic.

How is ample production and equitable access being ensured?

In April 2020, a global collaboration of governments, global health organizations civil society groups, businesses and philanthropies came together to form the Access to Covid-19 Tools Accelerator, or the ACT Accelerator. The idea is to form a plan for an equitable response to the Covid-19 pandemic. There are four pillars under the ACT Accelerator, of which vaccines is one.

A COVAX Facility has been established recently under the vaccine pillar of the ACT Accelerator to manage the large, diverse portfolio of Covid-19 vaccines that are under development, to ensure a global sharing of risks associated with the development of Covid-19 vaccines and an equitable access based on fair allocation of the available vaccines. The COVAX Facility is a mechanism designed to guarantee rapid, fair and equitable access to Covid-19 vaccines worldwide. By connecting a pool of demand to a pool of supply, it will allow countries access to a broad portfolio of Covid-19 vaccines and provide manufacturers access to a demand-secure market.

All countries are being invited to participate in the facility. The participating countries are expected to receive access to vaccines procured by the Facility at the negotiated price.

WHO is also developing a global allocation framework, for vaccines and other Covid-19 tools, based on fair and equitable access principles. The framework is currently being developed with member-state input.

Along with accelerating research and ensuring manufacturing capacity, WHO is also working with countries to develop regulatory capacity, as well as supportive policies and delivery channels. These will be essential to get a successful vaccine out to people.

WHO is committed to and will continue to advocate to countries to ensure that as medicines and vaccines are developed, they are shared equitably with all countries and people.

Who should receive the vaccines first?

This was discussed extensively at the recent International Symposium on Novel ideas in Science and Ethics of Vaccines against Covid-19 pandemic, in which leading experts from across the globe participated.

It is anticipated that the initial tranche of doses will be made available to all countries to ensure health and other essential frontline workers can be immunized, followed by other high-risk populations.

The allocation framework for Covid-19 vaccines also aims to help countries prioritize at-risk populations as they develop in-country vaccination strategies.



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