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A ‘science first’ approach to making COVID-19 vaccines, says Singapore pharmaceutical industry body

A ‘science first’ approach to making COVID-19 vaccines, says Singapore pharmaceutical industry body

FILE PHOTO: Small bottles labeled with a "Vaccine COVID-19" sticker and a medical syringe are seen in this illustration taken taken April 10, 2020. REUTERS/Dado Ruvic/File Photo

SINGAPORE: Pharmaceutical firms are committed to a “science first” approach in the development of COVID-19 vaccines even as the pressure piles on amid a global race to end the pandemic, said a representative from an industry body in Singapore.

Vaccine development is traditionally a complex task that can take as long as 20 years, said Mr Ashish Pal, vice-president of the Singapore Association of Pharmaceutical Industries (SAPI).

“You have pre-discovery phase that can last two to four years. Pre-clinical and clinical trials can take anything between five and 15 years and that does not include regulatory approvals and manufacturing," he said.

The industry has made progress about nine months since the COVID-19 outbreak began – with more than 169 vaccine candidates under development, 26 of which are in human trials, according to the World Health Organization (WHO) – but it is also aware of the dangers of haste.

“Typically, vaccine development processes are long, complex and not bereft of risk,” said Mr Pal, who is also the managing director of MSD Singapore and Malaysia, in an interview with CNA.

“Companies that are developing vaccine candidates are now working on multiple elements of the development process … so (it) is in many ways much more risky, given the fact that a lot is happening much faster, but also in tandem.”

He added: “More than ever, there is need for urgency but most importantly, without compromising on safety.”

Mr Pal pointed to the joint pledge made by nine American and European vaccine developers.

These vaccine developers – Pfizer, GlaxoSmithKline, AstraZeneca, Johnson & Johnson, Merck & Co, Moderna, Novavax, Sanofi and BioNTech – said in a statement that they would “uphold the integrity of the scientific process as they work towards potential global regulatory filings and approvals of the first COVID-19 vaccines”.

READ: US, European COVID-19 vaccine developers pledge to uphold testing rigour 

“It’ll be science first and I think that is what people can take a high level of comfort in,” said Mr Pal. 

“Obviously there's a lot out there about timeframes but the whole process as I've outlined is complex,” he added. “It's probably too early at this point in time to speculate when a vaccine candidate would be approved.” 

OTHER CHALLENGES

A vaccine has long been awaited to help immunise the world against a novel coronavirus that has caused more than 900,000 deaths and global economic turmoil.

The WHO said earlier this month that it does not expect widespread vaccinations against COVID-19 until the middle of next year. None of the candidate vaccines in advanced clinical trials so far has demonstrated a “clear signal” of efficacy at the level of at least 50 per cent sought by the WHO, it said.

The challenges were seen when a potential vaccine being developed by British drugmaker AstraZeneca and Oxford University was suspended two weeks ago, following an unexplained illness in a study participant.

The WHO’s chief scientist had called the pause a “wake-up call” of the ups and downs in clinical development but urged researchers not to be discouraged.

The vaccine, seen as one of the most advanced in development, has been given the green light to resume trials in Britain, the company said on Sep 12, although it did not elaborate on when global trials will restart.

READ: AstraZeneca resumes UK trials of COVID-19 vaccine halted by patient illness

But the challenges don’t end after the development of a COVID-19 vaccine.

The manufacturing and distribution of any vaccine successfully created will be key areas where industry and global cooperation are needed, said Mr Pal, adding that there are efforts are under way.

Given how manufacturing will likely have to be done at “an unprecedented scale”, he said: “Companies are probably using a variety of options – from expanding manufacturing sites to either refitting or repurposing their global networks, and identifying additional opportunities to supplement their networks.”

There is also “a very clear focus by companies … to work in close parallel”, he noted.

Asked about the likelihood of industry collaboration given the lucrative nature of a successful vaccine, Mr Pal answered: “We are already seeing many examples of industry and academia, as well as industry and industry coming together so I think there are already some very real examples of unique and relevant collaboration out there today.”

Distribution of the vaccines will be another crucial area and this will have to be based on “an equitable distribution that is agnostic to economic tiers”, said the SAPI vice-president.

The COVID-19 Vaccine Global Access (COVAX) facility – a global COVID-19 vaccine allocation plan led by the WHO, the GAVI vaccine alliance and the Coalition for Epidemic Preparedness Innovations – has this in mind, he added.

READ: Commentary: Vaccine politics could hamper a COVID-19 recovery

Launched in late April, the COVAX facility works with vaccine manufacturers to provide countries worldwide with “equitable access to safe and effective vaccines”, said the WHO. It aims to deliver at least 2 billion doses of approved vaccines by the end of 2021.

For now, it relies on nine experimental vaccines that are across various stages of development and employ a range of different technologies and scientific approaches.

So far, 92 lower-income nations are seeking assistance via the COVAX facility, while another 80 higher-income nations have expressed interest. Singapore is among the countries that have submitted an expression of interest to procure COVID-19 vaccines through the facility.

READ: COVID-19: Singapore to prioritise vaccination of higher-risk groups, those more likely exposed to virus

However, some countries which have secured their own supplies through bilateral deals, including the United States, have said they will not join COVAX.

Last month, WHO chief Tedros Adhanom Ghebreyesus warned that countries putting their own interests ahead of others in trying to ensure supplies of a possible vaccine could make the pandemic worse, and called for an end to “vaccine nationalism”.

On whether the emerging trend of “vaccine nationalism” could impede the effectiveness of the COVAX facility, Mr Pal would only say: “I think what countries choose to do is obviously an individual choice … COVAX is a very important platform at this time more than ever before (because) its intent is in line with how best the world can navigate this global pandemic. 

“From our perspective as SAPI, we encourage all countries to really actively engage with the COVAX facility given the underlying mission of COVAX.”

SINGAPORE’S ROLE

Founded in 1966, SAPI has 34 members and seven associate members, with a majority being multinational firms involved in the research and development of innovative biopharmaceutical medicines. They include the likes of MSD Pharma, Pfizer, AstraZeneca, GlaxoSmithKline, Johnson & Johnson and Eisai.

Mr Pal would not comment specifically if any of the association’s members are carrying out experimentations of COVID-19 vaccines here, but he stressed that Singapore plays an important role in the global biopharmaceutical industry.

He pointed to how the industry, which employs more than 24,000 people, remains a bright spot for the Singapore economy despite the current pandemic-fuelled downturn.

READ: New scheme to help 300 mid-career PMETs enter biomedical science sector over the next year

Official data showed the biomedical manufacturing cluster grew 26.7 per cent in the first half of the year, compared with the same period a year ago, on the back of a sharp increase in worldwide demand for pharmaceutical and healthcare products which accelerated the production of active pharmaceutical ingredients and biological products.

“We have companies that have significant manufacturing and research and development (R&D) presence in Singapore. The range of manufacturing and R&D presence is varied and what each company is choosing to do relative to COVID-19 in Singapore is obviously company proprietary,” said Mr Pal.

“But Singapore is a very important element of the biopharmaceutical industry, both from a regional and global standpoint.”

Citing Singapore’s strengths in having a strong intellectual property rights regime and skilled labour, Mr Pal said: “If you look beyond the pandemic, we remain very confident as an industry of our investments in Singapore.”

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Source: CNA/sk

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