Whether true or just politically convenient they have blamed the slow ramping of Covid vaccine production on the US banning exports of some necessary equipment and materials:
The two main vaccine manufacturers, SII (which makes the local version of AstraZeneca's vaccine called Covishield) and Bharat Biotech (which makes Covaxin), [theoretically] can together produce around 90 million doses a month.
They have been promised $400m and $210m each from the Indian government to boost production.
[...] Earlier this year, President Biden invoked the US Defense Production Act (DPA), giving US vaccine makers priority access to specialised equipment, such as pumps and filtration units.
India's biggest vaccine maker, the Serum Institute of India, which produces Covishield, complained of shortages of specialised materials from the US.
The firm said it had faced difficulties importing cell culture media, single-use tubing and specialised chemicals from the US. [...]
The Serum Institute of India (SII) said in January it was planning to ramp up production of Covishield and the US-developed Novavax (not yet licensed for use in India) to 100 million doses a month by March.
But the plans have been pushed back to June. [...] The SII was expected to deliver the first 100 million doses between February and May - but Indian government data shows that it has so far delivered only 30 million (this includes 10 million set aside for India itself under Covax).
As with all politically tied blame games, it's probably going to be little difficult to untangle this... AZ itself has had difficulties with production scaling in the EU etc.
AZ subcontractor (CordenPharma) company officials in the EU also mentioned "a need to send some ingredients to foreign plants—including in the U.S.—for purification", so there may be some truth to it... how much of that accounts for the delays it's hard to say.
Regarding patents for Covid-19 therapeutics, this is a somewhat older dispute (that has been reiterated recently though). Basically South Africa, India, and some other low-income countries proposed sometime in October (at the WTO/TRIPS) for IP on Covid-19 therapeutics, including vaccines to be waved. However, the high-income countries (US, UK, and the EU) rejected this proposal. The WHO also mostly sided with the high-income countries on this:
John-Arne Røttingen, who chairs the WHO Solidarity Trial of COVID-19 treatments, agrees that technology transfer is crucial, but says that voluntary mechanisms are a better way to achieve this. The patent waiver, he says, is the “wrong approach” to the problem because COVID-19 therapeutics and vaccines are complex biological products in which the main barriers are production facilities, infrastructure, and know-how. “IP is the least of the barriers”, he says.
It's somewhat harder to say what might have happened in the counterfactual scenario, but India also did not even approve the Pfizer or Moderna vaccines until April 13, 2021:
Pfizer was among the first companies to apply for an emergency use authorisation in India, back in December. At the time, Serum Institute of India’s Covishield, which is essentially the AstraZeneca vaccine, and India’s homegrown Covaxin had also applied for approvals.
A big hurdle in granting Pfizer an approval was the fact that its vaccine needs to be stored at ultracold temperatures, needing a specific cold storage mechanism that had limited availability in India.
At the time, the government had insisted on Pfizer’s bridging study in India, and the pharmaceutical company wanted India to first commit to buying the shots. Eventually, Pfizer withdrew its application in February.
Similarly, India’s subject expert committee had deliberated for several months before granting Sputnik V, an emergency approval, even though the Russian vaccine maker had tied up with India’s Dr Reddy’s Laboratories for local trials. Unlike Covaxin, whose phase III data are yet to be published in a peer-reviewed journal, both Pfizer and Sputnik V have established efficacy of over 90%. [...]
Just days before allowing foreign-made vaccines to be imported, the government had a strong stance against it.
In a letter to prime minister Narendra Modi on April 9, Congress leader Rahul Gandhi had appealed that approvals be granted to all other viable vaccine candidates and that the drive be opened up for younger age groups.
At the time, Ravi Shankar Prasad, India’s minister for law & justice, and communications and information technology, hit out at Gandhi for being a “lobbyist” for pharmaceutical companies.
In four days, though, the government made a complete U-turn and said that it was going to make sure all priority groups receive the vaccine. India has set itself a target of vaccinating 300 million people, including healthcare and frontline workers, by August.
Some in India are indeed still arguing that the price would come down if the mRNA vaccines were produced in India, but I haven't seen concrete figures and even supporters of this idea admit that lead would have been 8-9 months before local production could have started:
“Price of the mRNA vaccine will become quite reasonable (in India) if Moderna comes on board with us and allows our pharma companies to produce the vaccine here. The technology is very simple and we will take 8-9 months to start manufacturing,” the CSIR told ThePrint.
Despite the Indian claim that it's all very simple, some other experts quoted by Nature disagreed with that assessment:
Could other companies pitch in to manufacture more? Making mRNA vaccines has a simplicity about it, but scaling up is tricky, says Zoltán Kis, a chemical engineer at the Future Vaccine Manufacturing Hub at Imperial College London. Because it is a new process, there’s a shortage of trained personnel. “It’s very hard to find these people who are trained and also good at it,” he says.
But the key bottleneck in mRNA-vaccine manufacture is a worldwide shortage of essential components, especially nucleotides, enzymes and lipids. This is because relatively few companies make these products, and not in sufficient numbers for global supply. Moreover, these companies are proving slow to license their manufacturing so that others could do this.
For example, every RNA strand requires a ‘cap’ that prevents the human body from rejecting it as foreign material. It’s the most expensive component, says Kis, and the intellectual-property rights for a popular cap design are held by one company — TriLink Biotechnologies, based in San Diego, California. Similarly, a small number of companies hold the intellectual-property rights for one of the four lipid nanoparticles that form a ‛cage’ around the RNA, Kis adds.
That said, manufacturers of component parts are now expanding their production. TriLink, for example, has built new facilities in California. And Merck, based in Darmstadt, Germany, is expanding its supply of lipids to BioNTech, Pfizer’s collaborator. [...]
“Last February [2020], Pfizer and Moderna were already thinking about how to make more. They started buying GMP [good manufacturing practice] companies,” Weissman says, referring to firms that already fulfil the numerous rigorous requirements for producing safe food, drugs or medical equipment. “They [also] started leasing other companies, but they had no control on the raw materials. Maybe governments could have used their authority to make chemical companies produce more raw materials, but that’s a lot to ask for when the drug hasn’t even been approved,” he adds.
Basically, it's not terribly clear if that if India had started production on mRNA vaccines already they would be that much far ahead in overall Covid-19 vaccines production. From the looks of it, they would have had to build a whole supply chain for these. A bit lesser known is the fact that there is one "independent" effort to make mRNA vaccine (which reminds a bit of the Oxford-AZ collaboration):
the University of Pennsylvania, which owns sufficient intellectual-property rights relating to mRNA vaccines to strike out on its own, is helping Chulalongkorn University in Bangkok to develop a vaccine-making facility.
“If you look at vaccine roll-out right now, it’s going to be two years before Thailand and other lower-income countries get vaccine,” says Weissman, who is collaborating on the project. The country’s government wasn’t willing to wait, he says. “They were willing to put up the money … so that they’ll be ready to treat their people by the end of this year.”
And even in India there's one such vaccine being developed:
An mRNA-based vaccine HGCO 19 developed by Gennova Biopharmaceuticals Ltd., of Pune, India, and HDT Bio Corp., of Seattle, was cleared in December to initiate phase I/II trials.
Now on this angle, Canada perhaps has more a leg to stand on and complain as one of their companies (Biolyse) says they made an offer to J&J to license their Ad26-based vaccine (in view of producing 20 million doses per year), but they were turned down, so now they are asking the Canadian government to compulsorily license to them the J&J-related patents. Something similar was heard from a company in Bangladesh, but regarding a protein-based and even parts of the mRNA vaccine manufacturing process.
Bangladesh’s Incepta Pharmaceuticals Ltd., for example, says it has a production line that could make 350 million doses a year of protein sub-unit vaccines, such as that developed by Novavax Inc. Among the vaccines Incepta, which has 10,000 employees, already makes are shots against cholera and hepatitis B. The company also says it has a “fill-and-finish” facility that could transfer another 500 million doses from bulk containers to final-use vials, saying that it could easily do this for mRNA vaccines.
“We have a tremendous facility here lying idle. It is very frustrating,” said the company’s chairman, Abdul Muktadir, who dismissed safety concerns as “pure nonsense.” Mr. Muktadir said he was ready to pay to use the intellectual property rights, but that his offer of a licensing deal received no response from U.S. manufacturers.
[...]
Pfizer-BioNTech and Moderna haven’t licensed their Covid-19 vaccines to any producers in the developing world so far.
BioNTech’s Mr. Sahin said this week that his company was contemplating potential production in South America and Africa, but offered no details.
A spokesman for Moderna said that actively sharing the know-how with manufacturers in the developing world would have pulled resources away from its own efforts to produce hundreds of millions of doses during the pandemic. He declined to say whether Moderna opposed the Trips waiver proposal.
From the same source (WSJ):
More than 100 members of Congress support a waiver. A recent letter to Mr. Biden from Vermont Sen. Bernie Sanders and nine Democratic senators, including Elizabeth Warren, said that “delaying vaccine deployment in the developing world to lock in profit-boosting patent protections threatens the safety of the American public that financed the vaccines in the first place.”
So there seems to be some political buy-in in the US at the moment at least on the left-most side of the political spectrum. Whether it will or would have actually helped had this been done already... I'm not going to try and speculate.
But interestingly enough though, even some left-wing sources like Jacobin magazine point out that merely forcing the licensing of patents probably wouldn't have helped much; the article in fact accused Moderna of a publicity stunt when Moderna announced they would not be enforcing their patents on Covid-19...
During a media call held in May 2020, the director of the pharmaceutical industry’s global trade association, Thomas Cueni, was asked about the possibility that developing countries might issue compulsory licenses to break patents on COVID-19 vaccines. He shrugged off the question by saying out loud what Moderna’s executives intentionally left unsaid.
“The focus on IP in vaccines shows a lack of understanding, because with vaccines, it’s all about know-how,” said Cueni. “In the history of IP, there’s never been a compulsory license for vaccines. Not for nothing. It really doesn’t solve the problem.”
[...] The vaccines at the center of today’s IP debate illustrate the difference. Unlike HIV/AIDS antiretrovirals [some of which were forced-licensed]— classic “small molecule” drugs easily reverse-engineered and manufactured using existing technology — bio-based medicines and new-generation vaccines are more complex, with the needed technologies and manufacturing specs padlocked by trade secrets, along with biological materials like cell lines. Acquiring this information requires the active and willing participation of the patent owner to share its secrets to show exactly how they work, an aspect of licensing deals known as tech-transfer.
Even for mRNA vaccines which conceptually are simpler to manufacture (no cells or viruses to grow), the trickiest manufacturing step appears to be getting the mRNA into the LNP. And apparently not much has been published about that; there don't seem to be any commercially available machinery that does it, for instance. It's all in-house processes for now.
A peer-reviewed publication however estimated that raw mRNA production itself is actually
the main limiting factor. This study suggests that using self-amplifying RNA (saRNA) vaccines
would have thus be the way to overcome it. Basically, if you can't get academics who are second-guessing what the industry is doing to agree where the manufacturing bottlenecks lie... it's probably fair to say that the RNA-vaccines industry is keeping their trade secrets close enough to their chest...
In today's [May 2021] news, a more rounded assessment from the same Serum Institute CEO:
In a statement on Monday, Poonawalla added: “Vaccine manufacturing is a specialised process. It is therefore not possible to ramp up production overnight. We also need to understand that the population of India is huge and to produce enough doses for all adults is not an easy task.” [...]
Over the past 15 days, the daily rate of vaccinations fell from an average of 3.2m a day to 2.3m a day. If India wants to vaccinate everyone over the age of 18 this year, 7.5m doses will be needed to be administered every day.
Of course, if you ask the opposition in India, it's the government's fault... (from news a couple of weeks ago):
"The Modi government has mismanaged the situation, exported vaccines and allowed a shortage to be created in India," opposition Congress Party president Sonia Gandhi said during a special meeting over the weekend to address the COVID-19 crisis. [...]
Experts say the government failed to anticipate a higher demand for vaccinations when it opened up its first drive. Officials also did not take into account the vaccines that the country had shipped out through its ambitious "Vaccine Maitri," or "vaccine friendship," initiative with other countries. [...]
"The tangible costs of the nonavailability of vaccines at home far outweigh the non-tangible benefits of vaccine diplomacy. We should have ensured better use domestically," the international relations expert Happymon Jacob told DW.
India has shipped more than 60 million doses to 76 nations, delivered either under the World Health Organization-backed COVAX mechanism or as part of commercial deals. Of the countries that received India-made vaccines, at least 37 got them for free — 17 of them through COVAX, under the aegis of the Global Alliance for Vaccines and Immunization (GAVI). Both major vaccine producers in India still have commercial obligations and huge pending orders.
At one point (in mid-March) India had outdone China in terms of the percentage of production exported (65% vs 60%) (although not in raw numbers).
China appears to be implementing a slow domestic rollout of vaccines while sending 60 percent of its production of Sinovac and Sinopharm vaccines as aid to fifty-three countries and exports to twenty-seven, according to government reports.
India, facing logistical problems that have slowed its vaccination effort, has sent 65 percent of its production of Covaxin and Covishield (produced in India under license from Oxford-AstraZeneca) vaccines to other countries, mainly in South Asia. To counter China’s vaccine diplomacy, the leaders of the United States, India, Japan, and Australia announced during their first virtual Quad Summit that they would supply one billion doses of vaccine to Indo-Pacific countries by 2022—by scaling up production in India in an effort financed by the other three members of the bloc.
At the end of March, India has paused exports for (at least) two months.
