COVID : Booster doses , paediatric vaccines & drug breakthroughs
Fiona Barry , associate editor at GlobalData PharmSource , believes there are more COVID-19 deals ahead for contract manufacturers
This article is a part of the ninth edition of the CPhI Annual Report – a comprehensive report analysing key trends and innovations in pharma – was commissioned by Informa Markets and will be released at CPhI Worldwide at Fiera Milano , Italy , on 9-11 November .
More than 1,000 vaccines and therapies are in development for COVID-19 and more than 30 have been approved or granted Emergency Use Authorisation . The GlobalData Pharma Intelligence Centre shows that 230 contract manufacturing agreements for COVID-19 vaccines and therapies have been publicly disclosed to date . This is just the tip of the iceberg , as many more exist and will be disclosed retrospectively . The scale of COVID-19 vaccine doses needed means that sponsor companies - even the largest multinationals , who ordinarily might have chosen to manufacture some of their innovative drugs in-house - are turning to CMOs to fulfill orders . At the beginning of the pandemic , slightly more than half of these agreements were for vaccines and this proportion has risen recently . 1 It will continue to rise , as several vaccines have proven their safety and efficacy , received approval and are being ordered in billions of doses by numerous governments . Some of these manufacturing contracts are for a huge number of doses and can span a decade . Nonetheless , they are spread between a great number of CMOs . Specifically , more than 150 CMOs are involved in publicly disclosed contract manufacturing agreements . Many of these contracts are for 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 . Near- and long-term developments will increase the size of existing vaccine manufacturing contracts and create new ones . The prospect of administering the vaccine in paediatric populations or administering one or more extra vaccine doses to all populations , both of which are currently under study , will further raise manufacturing volumes and bring CMOs more highly specialised work making these novel molecules . 2 On 18 August , the US Centres for Disease Control and Prevention ( CDC ) and the FDA announced a plan to offer the US general public a third shot of either Pfizer / BioNTech ’ s or Moderna ’ s COVID-19 vaccines , beginning on 20 September . 3 Depsite WHO criticism , the US is already administering a third dose to immunocompromised people ; Israel is also rolling out a third dose ; and many European countries will offer a third
Barry - Over 150 CMOs in disclosed vaccine agreements
dose to vulnerable groups . Under the FDA ’ s plan , a third shot of the Pfizer / BioNTech or Moderna vaccines will be given eight months after the second dose . The agency said that it is also likely that people who received the one-shot Johnson & Johnson ( J & J ) vaccine will need a second shot . It is possible that these extra doses will not be the last . If future data support a regular , seasonal immunisation program in response to the Delta variant or future variants , this will further increase manufacturing demand . However , the rate of manufacturing and distribution is limited . It is also probable that one or more vaccines currently in clinical development will be approved .
20 SPECIALITY CHEMICALS MAGAZINE ESTABLISHED 1981