Covid-19 vaccines: What is happening right now with their progress

• Britain has announced the approval of Pfizer-BioNTech’s Covid-19 vaccine
• It plans to roll it out from early next week 
• The Health Sciences Authority (HSA) here is in talks with another firm Moderna on its submission plan for its vaccine
• HSA is allowing companies to submit real-time data from ongoing studies while it does a regulatory review at the same time
• This could help speed up the approval process

SINGAPORE — It has been close to a year since Covid-19 was first reported and the number of cases across the globe continues to rise. 

Scientists have been working round the clock to develop vaccines to put an end to the pandemic that has claimed more than 1.48 million lives worldwide — a monumental task that typically takes years to complete.

The New York Times reported in late November that researchers are testing 57 vaccines in clinical trials on humans, and at least 87 preclinical vaccines are under active investigation in animals.

So far, two companies have made promising progress.

WHICH VACCINES ARE AT FRONT OF THE RACE

Reuters reported that both Moderna and Pfizer-BioNTech are in a tight race to launch their Covid-19 vaccines in Europe after both applied for emergency European Union (EU) approval on Tuesday (Dec 1). 

Drug maker Pfizer from the United States is collaborating with German development partner BioNTech. Moderna is an American biotech firm.

Both have reported preliminary findings of more than 90 per cent effectiveness in trials of their vaccines — an unexpectedly high rate.  

On Wednesday, Britain announced that it had approved the Pfizer-BioNTech Covid-19 vaccine for use and said that it will be rolled out from early next week. 

In Singapore, Moderna said on Monday that it is “forging ahead” with the rolling review process for its Covid-19 vaccine candidate with the Health Sciences Authority (HSA).  

HSA did not reply to TODAY’s questions about the latest development from Pfizer-BioNTech, but it did say that it has been in discussions with Moderna on the “rolling submission plan” for its Covid-19 vaccine. 

“Moderna has started submitting initial data and will continue to roll in data as soon as it becomes available as agreed with (us),” HSA said. “To ensure expeditious review, (we have) already started evaluating the available data submitted by Moderna.”

For its part, Singapore intends to secure a portfolio of Covid-19 vaccines, Health Minister Gan Kim Yong said last month. 

The Ministry of Health said then that a broad and diversified portfolio of vaccines would improve Singapore’s chances of securing a suitable vaccine against the coronavirus.

It added that while Singapore has expanded its vaccine portfolio with a number of pharmaceutical firms that use different technologies, and their vaccines are in different phases of clinical trials, not all will succeed or be suitable, safe and efficacious for all segments of the population. 

WHAT HSA HAS BEEN DOING

The authorities here have not yet made public a list of the firms that are in talks to provide vaccines to Singapore.

In the meantime, HSA said that it is allowing companies to submit real-time data from ongoing studies while it conducts a regulatory review at the same time. 

This is to try to speed up the approval process, while ensuring that there is enough scientific evidence to support the quality, safety and efficacy of the product. 

Even though it is possible to reduce the regulatory turnaround time, HSA stressed that there must be no significant adverse events, so relevant studies to support safety and efficacy are to be submitted before the vaccine is ready to be used publicly.  

PROGRESS OF OTHER VACCINES 

British bio-pharmaceutical firm AstraZeneca said on Nov 26 that more research was needed on its Covid-19 vaccine after questions emerged over the protection it offers.

The announcement came days after AstraZeneca and its partner, the University of Oxford, said that they were seeking regulatory approval for the vaccine, which had shown an average 70 per cent effectiveness.

That rate jumped to 90 per cent — similar to that in rival vaccines from Pfizer-BioNTech and Moderna — when an initial half-dose then a full dose was given to a sub-group of trial participants in error.

Interim late-stage trial results for Russia’s Sputnik V vaccine, published on Nov 11, showed a 92 per cent effectiveness.

Russian president Vladimir Putin ordered local authorities on Wednesday to begin mass voluntary vaccinations against Covid-19 next week, after the country recorded 589 new daily deaths from the coronavirus.

To do this, Mr Putin said Russia will have to produce two million vaccine doses within the next few days.  

China has at least three companies, including China National Biotec Group, CanSino Biologics and Sinovac Biotech that have signed deals with various countries to provide vaccines in bulk when ready. 

The Chinese drug makers had to look abroad for places to conduct late-stage trials for their vaccines because they have largely eliminated the coronavirus within their borders, CNN reported. 

In exchange, many of the host countries, such as Mexico and Brazil, have been promised early access to the successful vaccines, and even the technology to manufacture them for some.

CHALLENGES AHEAD

However, even when the vaccines are ready to be rolled out, there will be some logistical matters that need to be addressed.

Chief among them would be preserving the vaccine in the tropical heat for countries within Southeast Asia.

For instance, experts told Reuters that the genetic material used for making Pfizer-BioNTech’s vaccine needs to be at temperatures of -70°C or below.

Such requirements pose a particularly daunting challenge for countries in Asia, as well as in places such as Africa and Latin America, where intense heat is often compounded by poor infrastructure that will make it difficult to keep the "cold chain" intact during deliveries to rural areas and islands.

To help mitigate this problem here, Singapore Airlines has formed a Covid-19 Vaccine Taskforce to handle vaccine carriage.

It has since been awarded with the International Air Transport Association’s Center of Excellence for Independent Validators in Pharmaceutical Logistics (CEIV Pharma) certification to recognise that it has the capacity to ensure the safe transportation of pharmaceutical goods. 

WHY FASTER IS NOT ALWAYS BETTER

Although it may be tempting to think that the end of the pandemic might be in sight, particularly with news that vaccines are close to being available, several health experts have cautioned against hasty approvals.

In response to Britain’s approval of Pfizer-BioNTech, the European Medicines Agency, which is in charge of approving Covid-19 vaccines for the EU, said that a longer procedure to approve vaccines is more appropriate because it would be based on more evidence and checks.

Assistant Professor Hannah Clapham, who researches infectious disease at the Saw Swee Hock School of Public Health in the National University of Singapore, made a similar warning in a commentary for the East Asia Forum in October.

She said that typically, trials take three to five years to complete with a vaccine candidate that is already developed.

For Covid-19, developments have been sped up to a matter of months.

The trouble comes when vaccines are rushed through at the expense of extensive testing, which could produce safety issues that are yet to be determined.

Furthermore, Asst Prof Clapham said that individuals in the final stages of a trial are usually closely monitored and there is no guarantee of this happening in a real-world setting once vaccines are in use. 

Citing an AstraZeneca vaccine trial in the United Kingdom as an example, she said the trial had to be stopped and restarted after a participant had a suspected adverse reaction.

If the vaccines do not work as promised, she said this could lead to individuals feeling reluctant to get vaccinated. 

“Vaccine hesitancy is widespread and the risk of increasing vaccine hesitancy by rolling out a vaccine without adequate testing is not a risk worth taking,” she wrote.