FDA OKs third dose for Pfizer and Moderna Covid-19 vaccines
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FDA OKs third dose for Pfizer and Moderna Covid-19 vaccines

By GlobalData Healthcare 27 Aug 2021 (Last Updated August 27th, 2021 15:09)

Third doses of Covid-19 vaccines will aid public health and require more contract manufacturing.

The US Centres for Disease Control and Prevention (CDC) and Food and Drug Administration (FDA) have announced a plan to offer the US general public a third shot of either Pfizer/BioNTech’s or Moderna’s Covid-19 vaccines from 20 September. The switch from previous guidance comes after a rise in the highly transmissible Delta variant. The US is already administering a third dose to immunocompromised people, with Israel also rolling out a third dose. Many European countries plan to offer a third dose to vulnerable groups.

These extra doses will bring more highly specialised work making these novel molecules to contract manufacturing organisations (CMOs) (see BIO 2021: mRNA Vaccine Booster Shots for Covid-19 and Increasing Uptake Will Offer CMOs Lucrative Opportunities, B/POR, July 2021), as well as putting pressure on the world’s supply chains. Other developments could push volumes even higher. Companies are trialling vaccinations in children, and it is also probable that one or more vaccines or therapies currently in clinical development will be approved (see the forthcoming GlobalData report Covid-19: Contract Pharmaceutical Development and Manufacturing Relationships (Q3 2021)). If one or more of these candidates is found to be safe and efficacious, we can expect a flurry of contract manufacturing agreements.

Under the FDA’s plan, third shots of the Pfizer/BioNTech or Moderna vaccines will be given eight months after the second dose. The agency says it is also likely that people who received the one-shot Johnson and Johnson (New Brunswick, New Jersey) vaccine will need a second shot. It is possible that these extra doses will not be the last as if future data support a regular, seasonal immunisation program in response to the Delta or future variants, this would further increase manufacturing demand. But the rate of manufacturing and distribution is limited. The World Health Organisation (WHO) has called for a moratorium on ‘boosters’ until at least the end of September, so that at least 10% of the population of low-income countries can receive a first dose.

“We Underestimated the Crunch on Suppliers”

These developments will greatly aid public health and will require more contract manufacturing, expanding the volume of existing agreements and leading to new contracts. But they will also put pressure on supply chains. Looking back on the response so far to Covid-19, Janssen supply chain vice-president Remo Colarusso stated during the 13 July Data Catalogue Vocabulary (DCAT) webinar Manufacturing and Supply – Lessons Learned from the Pandemic that the pharma industry “underestimated the crunch on the suppliers”.

Also speaking at the webinar, Gilead Sciences (Foster City, California) chemical development and manufacturing operations senior vice-president Ken Kent agreed: “Every component product that touches your product, every disposable consumable, they were all under pressure. Things that you would never even anticipate early on in the pandemic. For example, carbon dioxide was in shortage because it’s a byproduct of the fuel industry, and we use that in processing. So simple things like that could trip you up and it really made us look a lot deeper into our supply chains.”

Mr Colarusso added that single-use disposable bioprocessing items, and even ink for labels, came into shortage: “It was a real lesson that it only takes one small mistake in the supply chain to really cause huge damage.” The result, he said, is that “people are going to revisit their supply chains and mitigate the risks much more.”

Vaccine Contracts Growing

The forthcoming GlobalData report Covid-19: Contract Pharmaceutical Development and Manufacturing Relationships (Q3 2021) analyses 230 publicly disclosed contract service agreements for Covid-19 vaccines and therapies. The report shows that there are more than 1,000 vaccines and therapies in development for Covid-19 and that 30 vaccines and therapies have been granted full or emergency use authorisation for Covid-19.

At the beginning of the pandemic, slightly more than half of these agreements were for vaccines. This proportion has risen and continues to rise, as several vaccines have proven their safety and efficacy, received approval and are being ordered in billions of doses by numerous governments.

The scale of required vaccine doses means sponsor companies are turning to CMOs to fulfil orders. This is true even for the largest multinationals, which ordinarily might choose to manufacture some of their innovative drugs in-house. Some of these contracts are for a huge number of doses and can span a decade, but nonetheless, Covid-19 manufacturing contracts are spread between a great number of CMOs, with more than 150 CMOs involved in publicly disclosed contract manufacturing agreements. Other CMOs may also be contracted to manufacture these products without making the arrangements public.

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