Experts say preliminary vaccine results promising but still need time for approval and use  

Younten Tshedup 

If 2020 is known for the disruptions and sufferings caused by the Covid-19 pandemic, the hope is that 2021 would be a turning point.

Over the past few weeks, there has been encouraging news about the Covid-19 vaccines, with some successful trails reported.

Over 45 vaccine candidates have advanced to the development phase and are close to wrapping up phase III testing across centres. Among these, at least four candidates have shown ‘promising’ preliminary results with more than 50 percent efficacy rate, so far.

The front-runners in the vaccine race

The American biotechnological company, Moderna Inc. claims that their vaccine, which makes use of novel mRNA (messenger RNA technology), during the phase III clinical trials in 30,000 volunteers have shown the efficacy of 94.5 percent.

Following the claims, the US Infectious Disease expert, Dr Anthony Fauci, termed the results ‘stunningly impressive’.

Interim results from Pfizer BionTech also claimed their vaccine showed over 90 percent efficacy rate during the clinical trials.

  The highly anticipated Covid-19 vaccine from the University of Oxford/AstraZeneca in their interim results stated that the vaccine provided over 70 percent efficacy and had the potential to deliver a 90 percent efficacy rate if used in a two-dose regime.

And the first Russian Covid-19 vaccine, Sputnik V, claimed an efficacy rate of over 92 percent.

However, with all the promising results, these vaccines remain under the scrutiny of the World Health Organisation (WHO), as the global public health organisation begins analysing the initial data before approving for the general usage.

The preliminary results so far have seen very high efficacy for some of these vaccine candidates. However, efficacy is a measurement made during clinical trials. Effectiveness of a vaccine, on the other hand, is how well a vaccine works in the real-world application.

WHO country representative, Dr Rui Paulo de Jesus, said that the claims made by the manufacturers so far have been ‘promising’. “However, for a full-proof efficacy, it may require more time. But until today, there are no major negative reactions reported from these vaccines.”

Dr Rui said that although the efficacy rate reported was as high as 90 percent, there were many grey areas concerning the virus that required a thorough review. He said that questions such as the duration of protection and if the protection would mean only the suppression of symptoms or complete protection against new infections needed to be answered.

With growing concerns from the economically superior countries already starting to strike deals with the vaccine manufacturers to ensure their pre-orders in billion dosages of the vaccines, Dr Rui said that global solidarity would be of utmost importance to fight the pandemic together.

“The pandemic has taught us that no country can work in isolation. No one will be safe until everyone is safe,” he said, adding that working in isolation would be not only detrimental to the individual country but also the entire world.

He said that the COVAX facility, of which Bhutan is also a member, would help solve the issue of timely and equitable distribution of the vaccine once the global health body approves its usage.

COVAX facility is the vaccine wing of the global collaboration – Access to Covid-19 Tools (ACT) Accelerator initiated in April this year in response to the pandemic. With over 180 participating countries, Dr Rui said that irrespective of the country’s economic status, every member must protect each other to fight the pandemic together.

He said that the facility is working towards reducing the financial burden on countries, particularly those that are developing and least developed. “At this stage, we cannot say how much and when would a country receive the vaccine, but the world leaders have put their commitments to come together to fight the pandemic.”

Dr Rui said that the WHO with help from global experts is carefully analysing the data of the manufacturers. “Although the manufacture of the vaccines has been expedited through various bypasses, the WHO has made sure there are no compromises on the safety and efficacy of vaccines.”

“It is not for us or anyone to abandon the preventive measures that we have been advising so far. While we wait for the good news and the vaccine to be approved, let us all be careful.”

Bhutan’s preparation  

To see if the country was ready to introduce the vaccine, the health ministry with WHO and other relevant agencies recently conducted the vaccine introduction readiness assessment tool (VIRAT) workshop.

Participants discussed the logistical aspect to the vaccine import, including the cold chain arrangements. Issues such as the capacity building of health workers, distribution strategy and priorities, funding, and the need to follow up on the side effects, if any were also discussed.

The health ministry plans to distribute the vaccine in a phase-wise manner.

The first phase will cover high-risk workers in healthcare facilities and active front-liners such as armed personnel and De-Suups. It would also include those above 60 years, and people living with comorbidities.

The second phase of distribution would cover passive front-liners such as individuals who are in constant contact with large groups (like media personnel). Students and staff of functional schools and institutions also fall in the second phase.

Children below 12 years and pregnant women would be vaccinated in the third phase while the rest of the population (age 13 to 60 years) residing in the country and the rest would be reached in the final phase.