05 Oct 2021
Posted in Pharma
Pharma industry needs to outsource manufacturing for COVID-19 vaccine boosters and children’s doses, says GlobalData
The pharmaceutical industry will need to outsource even more pharmaceutical manufacturing to keep up the pace with the expected developments of the COVID-19 vaccines and drugs, says GlobalData, a leading data and analytics company.
GlobalData’s report, ‘COVID-19: Contract Pharmaceutical Development and Manufacturing Relationships’, reveals that the coming changes, like the approval of COVID-19 vaccines in paediatric populations, and giving extra (or ‘booster’) doses, will raise the manufacturing demand above billions of doses that are already contracted. To produce these high volumes, the pharmaceutical world will have to turn again to Contract Manufacturing Organizations (CMOs), increasing the size of existing vaccine contracts and creating new ones.
There are more than 1,000 vaccines and therapies in development for COVID-19, and over 30 have been approved (or granted Emergency Use Authorization) for COVID-19. According to GlobalData, hundreds of manufacturing agreements have been publicly disclosed to date between COVID-19 vaccine and therapy developers and CMOs.
Fiona Barry, Associate Editor of GlobalData PharmSource, comments: “This is just the tip of the iceberg, as many more contract manufacturing agreements for COVID-19 vaccines and drugs exist and will be disclosed retrospectively.”
Since 20 September 2021, the US public has been offered a third shot of either Pfizer/BioNTech’s or Moderna’s COVID-19 vaccines, eight months after the second dose which could be shortened to five months, President Biden has said. Israel is also rolling out a third dose. The UK is offering a third shot to over 50s, vulnerable groups, and frontline health workers. The US Food and Drug Administration (FDA) says that it is also likely that people who received the one-shot Johnson & Johnson vaccine will need a second shot. In September, Johnson & Johnson announced positive data from its Phase III booster study, ‘ENSEMBLE 2’.
Ms. Barry continues: “It is possible that these extra doses will not be the last. If future data support a regular, seasonal immunization program in response to the Delta COVID-19 variant or future variants, this will further increase manufacturing demand. However, the rate of manufacturing and distribution is limited. The World Health Organization (WHO) has called for a moratorium on ‘booster’ shots until at least the end of the year, so that at least 40% of the population of low-income countries can be vaccinated.”
Many of these contracts are for messenger ribonucleic acid (mRNA)-based or recombinant vector vaccines, both of which are novel molecule types. Relatively, few service providers are capable of certain steps in their production, such as viral vector production or mRNA production, which requires specialist equipment. This work requires highly specialized CMOs. The CMOs benefiting most from COVID-19 vaccine development so far, by number of contracts that have been disclosed, are Catalent (based in New Jersey, US), Lonza (Basel, Switzerland), and Emergent BioSolutions (Maryland, US).