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mRNA vaccines: manufacturing challenges for CDMOs

By The Editor - 02 July 2020

As the pandemic still accelerates in several parts of the world (mainly the United States and Latin America, but also in China), vaccine makers face biggest medical challenges for several reasons.

Firstly, time to discover, test and bring to the market a vaccine-candidate is rather long. The World Health Organization is not certain that scientists will be able to create an effective Covid-19 vaccine. According to it, the main problem is that there has never been a vaccine for a coronavirus. If discovered, it will be the first one and obviously, it will take time. The estimate of the World Health Organization is "within one year".

Secondly, vaccine makers face their biggest medical manufacturing challenge in history, as several trials are developed at the same time and enough capacity doesn't exist yet.

It is the case with mRNA vaccines, that need extreme cold storage conditions
(-80 degrees Celcius). Plastic vials manufacturers must ramp up their production capacity to meet the demand of developers. In the meantime, mRNA vaccines developers (Moderna, Translate Bio) are working to make candidates stable at higher temperatures.

Collaborations to secure fill-finish manufacturing capacity are being signed between CDMOs and drug manufacturers. It was the case, end of June, between Catalent and Moderna for large-scale, commercial fill-finish manufacturing in Indiana.

Catalent will provide vials filling and packaging capacity, as well as additional staffing to support production of an initial 100 million doses of the vaccine candidate intended to supply the US market starting in the third quarter of 2020. Catalent will also provide clinical supply services from its facilities in Philadelphia, including packaging and labeling, as well as storage and distribution to support Moderna's Phase 3 clinical study for this candidate.

Separately, the FDA issued several guidelines this week, for approving a Covid-19 vaccine. Any vaccine must be at least 50 % more effective than placebo in preventing the disease. The agency also said it would not approve, or give emergency-use authorization, to any coronavirus vaccine unless the maker had clearly demonstrated proof of its safety and effectiveness in a clinical study. Moreover, the FDA noted it would not clear a vaccine simply if it leads to antibodies in patients' bloodstreams as it remains unknown what level of antibodies confers protection. After any approval, the agency will require further safety monitoring and vaccine recipients be followed for a year after treatment.

These guidelines were issued at the time when Pfizer and Germany's BioNTech revealed positive trial results on a coronavirus vaccine candidate. The product is one of several using messenger RNA technology. Based on this initial trial result, the two companies hope to progress to a larger US trial involving 30 000 participants within weeks. BioNTech and Pfizer expect to be able to manufacture up to 100 million doses of the vaccine by the end of 2020, and more than 1.2 billion doses by the end of netx year.

PHARMAnetwork magazine - Edition NO45 - May 2020: "mRNA IN THE FOREFRONT FOR VACCINE CANDIDATE"| Read...
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