Could a lift on vaccine patents help Tunisia manufacture the Covid-19 jab itself?

Fewer than 1% of Tunisians have had a single dose of coronavirus vaccine

Medical staff work inside an intensive care department for patients suffering from the coronavirus disease at a hospital in Ariana, Tunisia, April 26, 2021. Reuters

As Covid-19 cases explode across India, North African nations and other developing countries, there are renewed calls in Washington to waive intellectual property rights and force vaccine makers to share their formulas with the world.

While nearly 30 per cent of Americans have been vaccinated, in countries such as Tunisia, less than 1 per cent of the population has received even one dose of the vaccine.

On Tuesday Ro Khanna, a Democratic congressman from California, made a plea on CNN for the administration to pressure Pfizer and Moderna to “share the vaccine recipe with over 100 countries who are willing to do the manufacturing themselves”.

“It is just wrong – morally wrong, strategically wrong – for them not to share the vaccine recipe that was developed with US taxpayer support,” Mr Khanna said.

Research costs 

For decades, battles have been fought around the patents on lifesaving drugs, including those for HIV and cancer.

Drug makers claim that billions of dollars go into research and development of drugs, and they need to recuperate expenses through exclusive manufacturing and sales.

Critics say that kind of approach wreaks havoc on global health and stops developing nations from tending to their sick.

A group of about 60 nations, led by India and South Africa, have drafted a proposal to waive the World Trade Organisation's intellectual property rules, in a bid to make the vaccine locally, and, they say, save millions of lives.

While India boasts a strong pharmaceutical sector, much of the rest of the world lags behind.

Only eight countries in Africa produce or package vaccines, according to the WHO.

There are only three laboratories in North Africa, one of which is the Institut Pasteur in Tunis, where Dr Nizar Laabidi oversees production of the BCG vaccine, used to prevent tuberculosis.

The lab, which began producing the BCG vaccine in 1928, was refitted in 2004 to meet new health and safety standards, and is one of the leading BCG labs in the world.

"It's well known that BCG is one of the most complicated vaccines to produce," Dr Laabidi told The National.

His team of about 50 scientists, researchers and technicians oversee the production of the drug from cultivation to shipment.

Early in the pandemic his team began their own quest for a vaccine for Covid-19.

“We were looking at DNA and mRNA vaccines, as well as other types, but in the end we couldn’t get to clinical trials,” Dr Laabidi said.

Tunisia is suffering a severe second wave of infections, with daily new cases topping 2,000 and hospital intensive-care units almost full.

Yet slightly more than 271,000 Tunisians have been vaccinated since the country received its first doses six weeks ago.

Many Tunisians mistrust the vaccines and are hesitant about side effects.

Dr Laabidi said his lab could make one of the Covid-19 vaccines, in theory. But it would be an uphill battle.

“We’re a publicly funded institution and so we have a lot of problems with the procurement process," he said. "You can’t buy anything.”

Necessary updates to the lab and the raw materials could take months or years to procure.

After the lab was renovated in 2004, it took six years to begin producing vaccines again as they waited for supplies and personnel.

But updates to the facilities or finding qualified technicians are not the main obstacles.

Dr Laabidi says that even if the lab were completely refitted and fully staffed, the vaccine formula alone would not yield enough information for them to produce it.

“It would be very, very difficult and take a long time,” he said. “It would be more like producing a classic vaccine, so maybe 10, 15 years.”

Rachel Silverman, a policy fellow at the Centre for Global Development, said the patent wars drug companies have been fighting for decades are not the same for vaccines.

“There’s a big difference between a drug and a vaccine,” she said.

“A drug is a chemical compound and if you’re a competent generic producer, you can reverse engineer how to make that chemical compound.

"It’s only the patents that keep a producer from making and selling it.

“But you can’t really reverse engineer a vaccine”.

With hundreds of components and various steps and stages to stabilise lipids or extract mRNA, the vaccine production process, which is not included in the patent, would also need to be shared to make new production a success.

“Even the most advanced pharmaceutical companies, even if they have all of the state of the art equipment, they do not necessarily have this knowledge,” Ms Silverman said.

Technology transfers are something Dr Laabidi knows well. His team led a knowledge and technology transfer in Korea to help the country establish its own BCG lab.

The WHO has organised a special technology-transfer pool for Covid-19 vaccines, but thus far none of the makers have contributed to it.

Even if advocates persuade the pharmaceutical companies to share their recipes and technology for the vaccine, it might already be too late from an economic and epidemiological standpoint.

By the end of 2021, Duke University projects that 12 billion doses of vaccine will have been made at current capacity, enough to vaccinate about 70 per cent of the world’s population.

“The big question is, by the time the production line actually starts churning, will there be a market for whatever it's producing or will we already have enough vaccines at current capability?” Ms Silverman said.

Dr Laabidi agreed: “By the time we could make the vaccine, there will be other newer diseases we should be focusing on.”