mRNA vaccine manufacturers loathe to share know-how

Moderna, which was funded $1 billion for research by the U.S. government, said in October 2020 that it will not enforce COVID-19-related patents against those making vaccines intended to combat the pandemic. But the company has refused to transfer technology to the South African hub to manufacture its mRNA vaccines for distribution to the African Union. Pfizer has been opted to sell another 500 million doses to the U.S. government for supply to LMICs instead of entering into joint ventures to contract manufacture the vaccines.

While many low- and middle-income countries have received by far insufficient supply of vital COVID-19 vaccines so far, vaccine inequity has been most striking in Africa. Of the nearly 6 billion doses administered globally, only 2% of those have been in Africa. And less than 3.5% of people in Africa have been fully vaccinated till date.

In contrast, 54% of the total population in the U.S. is fully vaccinated. After approving booster shots for the immunocompromised people, on September 22, the U.S. FDA greenlighted booster shots for people older than 65 years, adults between 18 and 64 years who are at high risk of severe disease and those at high risk of getting infected and at high risk of serious complications of COVID-19 including severe disease.

With attempts by the African Union to buy vaccines not been successful, the continent has to wait for donations. It is to correct this anomaly so that low- and middle-income countries can have easy access to vaccines to fight the pandemic that in April the WHO and COVAX wanted these countries to produce COVID-19 vaccines themselves. For this, the global health body is facilitating the establishment of technology transfer hubs to transfer necessary technology to manufacture COVID-19 vaccines and provide training to interested manufacturers in these countries.

The initial focus has been on developing vaccines using the mRNA vaccine platform and expanding to other technologies in the future. According to Dr. Gagandeep Kang, Professor of Microbiology at CMC Vellore the reason why WHO zeroed in on mRNA vaccines is because such vaccines have been found to be extremely efficacious in protecting against COVID-19, and protection is maintained to a large degree against variants. Second, the technology needed to manufacture mRNA vaccines is very flexible and allows relatively rapid adaptation of the vaccine to variants, if needed. Third, such vaccines can be produced by manufacturers of medicines and medical active substances, and finally, the availability of several technical features that are free of Intellectual Property Rights in many countries of the world. 

The WHO, a South African consortium — Biovac, Afrigen Biologics and Vaccines, a network of universities and the Africa CDC — and COVAX partners are working to set-up the first technology transfer hub in South Africa. The assumption is that companies such as Pfizer and Moderna will show a “willingness to transfer technologies”.

As early as October last year, Moderna announced that it will not enforce patents related to its mRNA vaccine during the course of the pandemic. “We feel a special obligation under the current circumstances to use our resources to bring this pandemic to an end as quickly as possible. Accordingly, while the pandemic continues, Moderna will not enforce our COVID-19 related patents against those making vaccines intended to combat the pandemic,” Moderna said last year.

However, according to an exclusive Reuters report, the promise made last year by Moderna isn’t translating into reality as the company is yet to reach a deal to transfer the technology to the South African hub. The New York Times quoted Dr. Martin Friede, a WHO official and Charles Gore, who runs a United Nations-backed nonprofit organization, Medicines Patent Pool as saying that they have had “trouble getting Moderna to the negotiating table”.

“We would love to get a discussion with Moderna, about a license to their intellectual property — this would make life so much simpler, but for the moment all attempts have resulted in no reply,” Dr. Friede told The New York Times.

It also reported a Moderna spokeswoman saying that the company was “willing to license its intellectual property for COVID-19 vaccines to others for the post pandemic period.” In effect, contrary to the promise made last year, the company is unwilling to license its mRNA vaccine IP during the pandemic and transfer technology to the South African hub. Vaccination is one sure way to protect people from severe disease and death and end the pandemic.

Incidentally, unlike Pfizer that did not take any funding from the U.S. government to develop its vaccine, Moderna was given $1 billion as part of Operation Warp Speed to specifically fund its research efforts. Moderna’s vaccine was in part developed by NIH.

Dr. Lawrence Gostin, faculty director of the O’Neill Institute for National and Global Health Law and Georgetown University Law Center tweeted on September 22: “LMIC companies are ready & able to produce mRNA vaccines, but Pfizer-BioNTech & Moderna are refusing to share technology & know-how. LMICs are fed-up with going hat-in-hand to rich countries for donations, which never come in time or at the scale needed.” He then added: “Biden can legally compel mRNA manufacturers to sign technology transfer contracts in exchange for reasonable compensation. The DPA [Defense Production Act of 1950] confers vast powers to act for the national defense. The DPA specifically includes “emergency preparedness.”

Under pressure from U.S. President Joe Biden to enter into joint ventures to contract manufacture the vaccines in low- and middle-income countries, Pfizer took an easy route. It entered into an agreement with the U.S. to sell an “additional 500 million doses at a not-for-profit price for donation to low- and lower-middle-income countries and the organisations that support them”, according to a Pfizer release. The company had agreed to sell the first lot of 500 million doses in June. However, deliveries of the initial 500 million doses began only in August 2021 and only 300 million are expected to be shipped this year. The total one billion doses are expected to be delivered only by next September.

In July, Pfizer signed a deal with South Africa’s Biovac Institute to help manufacture around 100 million doses annually of the mRNA vaccine for distribution exclusively to 55 member States of the African Union. However, as per the Pfizer press release, the drug substance will be manufactured in Europe and shipped to Biovac. Clearly, the agreement is for “fill and finish” of the vaccine, which does not require technology transfer. Also, manufacturing of finished doses will commence only next year.

Even as President Biden wants 70% of the global population to be vaccinated by September next year, much of the low- and middle-income countries may not come anywhere close to the target unless companies freely share their technology and know-how.  

“I see no reason why only one or two companies should be considered when there are several companies that work on mRNA products,” Dr. Kang says. “Moderna is not the only company with the technology to transfer — it was just potentially the easiest. I have no idea why Moderna is not willing to participate given that they have set up contract manufacturing on other continents. However, WHO and COVAX have other potential partners with whom engagement is being explored.”

Published in The Hindu on September 25, 2021