A group of leading pharmaceutical industry executives called upon global health leaders to work together to unlock export barriers, open up supply chain bottlenecks, and encourage high-income countries that are hoarding vaccines to redirect their excess doses to the WHO co-sponsored COVAX global vaccine facility – as ways to rapidly scale up equitable vaccine access and beat back the pandemic.

The executives, including the CEO of Moderna and India’s Bharat Biotech, as well as GSK’s head of global vaccines, and the heads of the Developing Countries Vaccine Manufacturers Network (DCVMN) and the Biotechnology Innovation Organization (BIO), were speaking at an event Friday marking a year since the establishment of the WHO co-sponsored Act Accelerator COVAX initiative.

Patents and other IP constraints are not the main obstacle to expanding access to vaccines, they asserted.  And increasing vaccine manufacturing capacity in lower-income countries, while important, will take time to develop – given the complexities of vaccine production, they said, speaking at a forum sponsored by the International Pharmaceutical Manufacturers and Associations (IFPMA).

Rather, the best way out of pandemic lockdowns and losses of life is to make better use of available resources, they stressed, including smoother supply chains and vaccine sharing schemes with COVAX.

“We are on track to make a billion doses this year, and potentially to have up to 1.4 billion doses for 2022,” said Moderna CEO, Stephane Bancel, at the press briefing, adding that the company is also “in the final stretch to get an agreement with COVAX,” for distribution of the mRNA vaccine through the global vaccine equity pool.  But he stressed that expanding manufacturing capacity further, and in more locations, would sap efforts to produce doses this year – and could ultimately even cost lives.

“We need to focus on delivering as many vaccines as we can this year,” he said, while trying to add more manufacturing capacity risks “being a distraction limiting what we can do in 2021… and by next year there is going to be way too many vaccines for people on the planet.” 

United States Raw Inputs Are Key To Global Vaccine Manufacturing Supply Chains

Added Michelle McMurry-Heath, a former US Food and Drug Administration expert, unlocking supplies of key raw products and vaccine dose sharing are important low-hanging fruit in the battle against the virus:

“We need to recognise that there are only a handful of manufacturers across the globe who have that expertise on hand, and we need to focus on getting them the materials that they need to produce as many doses, as quickly as possible, and to release backlogs,” said Heath, who is now CEO of BIO, a global trade association organisation that represents biotech researchers in government, the private sector, and academic institutions.

This this includes items as basic as single-use plastics and filters for the vaccine manufacturing process, some of which can only be supplied from in the United States. Currently the US Defense Production Act (DPA) restrictions are holding up release of many of those raw inputs, she stressed, adding that: “the US has to take a hard look at itself…. This Defense Protection Act, which was really designed to withhold capacity, expertise, doses and raw materials to the US, customer was well intentioned – but somewhat misguided at this stage –  we need to get those raw materials, out to the limited manufacturing capacity that exists around the globe.”

In addition, she added, high income countries need to be encouraged to start dose-sharing with the COVAX initiative – following on the example of France’s announcement only today that it will share 500,000 vaccine doses.

“The US is projected to have as many as 200 million excess doses on hand by the spring, we need to focus on getting those doses to COVAX,” said Heath. 

Vaccine Companies Can be Counted In ‘Double Digits’

Vaccine quality, which require adherence to strict biosafety requirements as well as to sterile conditions, is also a critical issue, she underlined. And quality control failures in manufacturing plants, such as ones seen recently in the case of a Johnson & Johnson vaccine plan, can undermine already shaky public confidence in the quality of brand-new COVID-19 vaccines.

Added Sai Prasad, CEO of Bharat Biotech, which has developed the first indigenous Indian COVID-19 vaccine, “Vaccine companies you can probably count in double digits so we need to be careful about whom we are transferring technology to, and whether they can receive it as well.  Technology transfer cannot be done with an entity that has no experience.”

“I think that as industry, we need to increase the partnerships between innovators and vaccine manufacturers…. We need to be agnostic as to whether these companies are US, Europe, India, China or Brazil, for example. And I think there is [already] a good track record of that,” he added, noting that over 200 partnerships between big pharma innovators and developing country manufacturers have been formed already.

At the same time, he said, supply chain bottlenecks and export barriers are a big threat to scale up: “Some of the vaccines take 150 to 200 little components that come from different parts of the world. “So interruptions in just one component, can slow production significantly, he pointed out, referring to the Serum Institute of India’s recent problems securing certain inputs from the United States.

“We’ve had reports from the Serum Institute having problems with certain single use materials that are supposed to come from the United States… plastic bags for example which we think is a mundane consumable, because maybe a decade ago industry, as such, we were all thinking about going into single use systems, which involved a lot of single use consumables – but now this unfortunately has become an impediment, and a bottleneck.”

Rajinder Suri, CEO of the Developing Countries Vaccine Manufacturing Network (DCVMN), echoed that saying:  “We are on the verge of expanding and ramping up the capacities, which are really required to meet the global demand…..and we are certainty facing some of the bottlenecks, from cell culture mediums and serum adjuvant filters, and single use plastic bags, to bio reactors.

“Most of these materials are coming from the US – so if the DPA is not handled properly, then the supply chain will get impacted, and building the global capacity will adversely get impacted.” 

COVAX Distributions Should Accelerate – With Stronger US Support

On the brighter side, meanwhile, Heath said she was confident that with stronger support for COVAX from the new US administration of President Joe Biden, the global vaccine facility can make up for its comparatively slow start in the second quarter of the year.

“COVAX didn’t have full support of all the developed countries. Now that this is up to speed…. we need to focus on great efforts like COVAX which are just beginning to fully ramp up, and can deliver very affordable vaccines around the globe. I is the fastest way to get high quality doses to developing countries, and that speed is so critical,” she said. 

Added Bancel, “we are focused on working with COVAX to provide vaccine, right now.  COVAX is the way for us to get maximum access on the planet.” 

See entire press briefing: