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



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

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

“You have a pre-discovery phase that can last two to four years. Preclinical and clinical trials can take between five and 15 years and that doesn’t include regulatory approvals or manufacturing, “he said.

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

“Typically, vaccine development processes are long, complex and not without risk,” said Pal, who is also the managing director of MSD Pharma Singapore, in an interview with CNA.

“Companies that are developing vaccine candidates are now working on multiple elements of the development process … so (is) in many ways much riskier, given that many things are happening much faster, but also together.” .

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

Pal noted the joint commitment 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 while working on potential global regulatory filings and approvals of the first COVID-19 vaccines ”.

READ: US and Europe COVID-19 Vaccine Developers Commit to Uptake of Testing Rigor

“It will be science first and I think that is what people can be very comfortable with,” Pal said.

“Obviously, there are a lot of things about timing, but the whole process, as I have described, is complex,” he added. “It’s probably too early at this point to speculate when a candidate vaccine would be approved.”

OTHER CHALLENGES

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

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

The challenges were seen when a possible vaccine developed by British pharmaceutical company AstraZeneca and the University of Oxford pressed the pause button last week, following an unexplained illness in a study participant.

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

The vaccine, considered one of the most advanced in development, was given the green light to resume trials in Britain, the company said over the weekend, although it did not give further details on when global trials will resume.

READ: AstraZeneca resumes UK trials of COVID-19 vaccine halted over patient’s illness

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

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

Since manufacturing will likely have to take place at “an unprecedented scale,” he said: “Companies are likely using a variety of options, from expanding manufacturing sites to retrofitting or repurposing their global networks, and identifying additional opportunities to complement their networks “. . “

There is also “a very clear approach on the part of companies … to work in close parallel,” he noted.

When asked about the likelihood of industry collaboration given the lucrative nature of a successful vaccine, Mr. Pal replied, “We are already seeing many examples of industry and academia, as well as industry and industry coming together, so I think that there are already some very real examples of unique and relevant collaboration that exists today. “

The distribution of vaccines will be another crucial area and should be based on “an equitable and agnostic distribution at the economic levels,” said the vice president of SAPI.

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

READ: Comment: Vaccine policy could hamper recovery from COVID-19

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

For now, it is based on nine experimental vaccines that are in various stages of development and employ a variety of different technologies and scientific approaches.

So far, 92 lower-income countries are seeking assistance through the COVAX facility, while another 80 higher-income countries 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 will prioritize vaccination of the highest risk groups, those most likely to be exposed to the virus

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

Last month, the head of the WHO, Tedros Adhanom Ghebreyesus, warned that countries that put their own interests before those of others when trying to guarantee the supply of a possible vaccine could worsen the pandemic and called for an end to “nationalism of vaccines ”.

On whether the emerging trend of “vaccine nationalism” could impede the effectiveness of the COVAX installation, Pal simply said, “I think what countries choose to do is obviously an individual choice … COVAX is a very platform. important right now more than ever before (because) your 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 COVAX facilities given COVAX’s underlying mission.”

THE ROLE OF SINGAPORE

Founded in 1966, SAPI has 41 members, the majority of which are multinational companies involved in the research and development of innovative biopharmaceutical drugs. They include companies like MSD Pharma, Pfizer, AstraZeneca, GlaxoSmithKline, Johnson & Johnson, and Eisai.

Pal declined to comment specifically on whether any of the association’s members are conducting COVID-19 vaccine experiments here, but emphasized that Singapore plays an important role in the global biopharmaceutical industry.

He pointed out how the industry, which employs more than 24,000 people, remains a bright spot for Singapore’s economy despite the current pandemic-driven recession.

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

Official data showed that the biomedical manufacturing cluster grew 26.7 percent in the first half of the year, compared to the same period a year ago, due to a sharp increase in global demand for pharmaceutical and healthcare products that accelerated the production of active pharmaceutical products. organic ingredients and products.

“We have companies that have a significant manufacturing and research and development (R&D) presence in Singapore. The range of R&D and manufacturing presence is varied and what each company chooses to do in relation to COVID-19 in Singapore is obviously owned by the company, ”said Pal.

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

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

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