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COVID-19 Tracker – Status of the Top 6 vaccines candidates after a busy summer period 

Avertim has had a long experience working in the pharmaceutical and especially vaccines industry.
We are therefore closely watching the development of COVID-19 candidates and working with some of the leading companies to plan activities such as manufacturing ramp-ups.  

In this article, find out more about the latest development of the most advanced vaccines projects, often lead by partnerships of leading pharmaceutical development and manufacturing companies.

 

180+ vaccine candidates

The WHO tracks the global research efforts against COVID-19 and continuously reports on their progress.
As of September 2020, there are more than 180 vaccine candidates against COVID-19 in different stages of pre-clinical and clinical development (see Figure 1 or read our previous article). Scientists and companies are currently testing 35 vaccines in clinical trials (Phase I, II and III) and hoping to develop a safe and effective vaccine by next year.

Figure 1: Number of currently developed vaccines worldwide1

 

 

The most advanced vaccine projects worldwide in clinical development

 

BioNTech-Pfizer-Fosun Pharma with BNT162 RNA Vaccines

 

The German biotechnology company BioNTech is working in cooperation with Pfizer and Fosun Pharma on developing its RNA vaccines BNT162, which entered a combined phase I/II clinical trial in early May and is currently in a phase II/III trial. What happened lately?

  • At the start of July, they shared the clinical results and found that their vaccine candidates BNT162b1 and BNT167b2 both produce neutralizing antibodies against COVID19 virus. Furthermore, their clinical data revealed that the vaccine candidate BNT162b2 showed higher tolerability and caused significantly fewer side effects such as fatigue, headache and fevers. Therefore, they chose to proceed with a phase III trial.
  • On July 27, they launched a phase III trial in the United States and other countries including Argentina, Brazil and Germany, where around 23000 participants have been enrolled.
  • In the same month, BioNTech and Pfizer announced  an agreement with the U.S. government to provide 100 million doses of their vaccines at the price of $1.95 billion and ensure provision of 500 million additional doses.
  • Meanwhile, the companies have committed to supply the United Kingdom with 30 million doses and Japan with 120 million doses.
  • On August 5, they agreed to supply Canada with their vaccines if phase III clinical trials are successful. Should the clinical trials yield positive results, the two companies aim to submit a request for Biologics License Application (BLA) as early as October 2020.  
  • In September, BioNTech and Pfizer launched a 5th vaccine candidate named BNT162c2 in a phase I/II clinic trial after it showed promising results in preclinical studies.
  • On September 9, they  concluded exploratory talks with the European Commission (EU) for a proposed supply of 200 million doses of their investigational BNT162 mRNAbased vaccine candidate to EU Member States, with an option for further 100 million doses 

 

AstraZeneca-Oxford University with ChAdOx1-S vaccine (another name AZD1222)

 

The British-Swedish company AstraZeneca and the University of Oxford are developing a vaccine called ChAdOx1-S using viral vector technology.

  • In May, the U.S government invested $1.2 billion in AstraZeneca to support its vaccine development efforts and get access to 300 million doses.
  • On July 20, the company published clinical results from the phase I/II trial and showed that the vaccine was safe, triggered immune responses and caused no severe side effects. Its combined phase II/III trials launched in May and currently concerns 17000 participants across Brazil, the U.K. and South Africa.
  • On August 31, the company started a phase III clinical trial in the United States with 30000 volunteers to assess the effectiveness and rare side effects of this vaccine.
  • On August 14, AstraZeneca is the only company that already secured a  supply deal of 400 million doses of ChAdOx1S vaccine with the European Union if the trials obtain positive results.
  • On September 3, AstraZeneca has signed a manufacturing deal with New Yorkbased Albany Molecular Research Inc for sterile fill-finish duties of millions doses of this vaccine at the Albuquerque, New Mexico site.
  • On September 8, AstraZeneca paused clinical development of its COVID19 vaccine in response to an adverse event. One of the volunteers, a U.K. participant, suffered transverse myelitis and inflammation of the spinal cord that can be triggered by infections.
  • The clinical development has restarted around midSeptember, following confirmation by the Medicines Health Regulatory Authority (MHRA) that it was safe to do so.

 

Moderna-NIAD with mRNA1273 vaccine

 

 

The U.S. biotechnology company Moderna is developing RNA vaccines in cooperation with NIAD and moved the first COVID-19 vaccine into a human clinical trial in March.

  • By the end of July, the company had received nearly $1 billion from the U.S. government for its efforts on development of COVID19 vaccines. In the same month, the company launched its phase III trial of mRNA-1273 with 30000 participants and expects to complete it in late 2021.
  • On August 11, Moderna agreed to supply the United States with 100 million doses for $1.525 billion as well as access to an additional 400 million doses of the vaccine.

 

CureVac with CVnCoV vaccine

 

CureVac is a leading German   clinical stage biotechnology company in the field of mRNA technology. It is backed by Hopp BioTech Holding and the Bill & Melinda Gates Foundation. Here are some of the latest developments:

  • On  July 6, the European Investment Bank and CureVac signed a €75 million loan agreement for the development and largescale production of vaccines against COVID-19.
  • On July 15, the German Federal Ministry of Economics and Energy announced its commitment to invest €300 million, representing 23% of shares in CureVac through the Kreditanstalt für Wiederaufbau (KfW).
  • On July 20, GSK announced an equity investment in CureVac of €150 million, close to a 10% stake. GSK also paid an upfront cash of €120 million and a onetime reimbursable payment of €30 million for manufacturing capacity reservation, upon certification of CureVac’s commercial scale manufacturing facility currently under construction in Germany. The CVnCoV vaccine candidate developed by using self-amplifying mRNA (SAM) vaccine technology platform entered in a phase I clinical trial in mid-June.
  • On August 20, European Union conducted talks with CureVac about a supply deal of 225 million doses and an option of 180 million more doses.2 After approval by health authorities in August, a stage II clinical trial is planned to start in autumn 2020.
  • CureVac is expected to receive up to €252 million from the German Federal Ministry of Education and Research (BMBF) to support the development of its COVID19 vaccine candidate. The grant will be used for further development of the vaccine candidate as well as the rapid expansion of the vaccine production. CureVac expects funding of up to €103 million in 2020 and up to €149 million in 2021.

 

Johnson & Johnson and its Ad26.COV2.S vaccine

 

 

Johnson & Johnson is developing vaccines using viral vector technology and the clinical testing is currently in a combined phase I/II trial launched in July.

  • On August 5, the company committed to supply the U.S. with 100 million doses of this vaccine for $1 billon if clinical trials succeed.4
  • On August 13, the European Union has launched advanced talks about the envisaged contract with the company to purchase 200 million doses.5
  • The company announced on August 31 to supply Canada with 38 million doses of the vaccine.
  • The latestage vaccine trial is expected to start in September with up to 60000 people

 

Sanofi-GSK and their recombinant protein vaccine in combination with adjuvants

 

Sanofi is working on recombinant protein vaccines in combination with adjuvants developed by GSK to stimulate the immune system.

  • On July 29, the partners reached an agreement with the British government to provide up to 60 million doses if the vaccine succeeds in trials.
  • At the end of July, the United States agreed to pay the companies $2.1 billion for 100 million doses
  • On July 31, the European Union negotiated with the companies to purchase 300 million doses.6
  • On September 3, the companies kicked off a phase I/II clinical trial for their candidate vaccine.7

 

 

References
  1. WHO. Draft landscape of COVID-19 candidate vaccines. https://www.who.int/publications/m/item/draft-landscape-of-covid-19-cand....
  2. Coronavirus: Commission continues expanding future vaccines portfolio with new talks. https://ec.europa.eu/commission/presscorner/detail/en/IP_20_1494.
  3. A Dose-Confirmation Study to Evaluate the Safety, Reactogenicity and Immunogenicity of Vaccine CVnCoV in Healthy Adults. https://clinicaltrials.gov/ct2/show/NCT04515147?term=vaccine&cond=covid-....
  4. Johnson & Johnson Announces Agreement with U.S. Government for 100 Million Doses of Investigational COVID-19 Vaccine. https://www.jnj.com/johnson-johnson-announces-agreement-with-u-s-governm....
  5. Coronavirus: Commission concludes further talks to secure future vaccine. https://ec.europa.eu/commission/presscorner/detail/en/ip_20_1481.
  6. Coronavirus: Commission concludes talks to secure future coronavirus vaccine for Europeans. https://ec.europa.eu/commission/presscorner/detail/en/ip_20_1439.
  7. Sanofi and GSK initiate Phase 1/2 clinical trial of COVID-19 adjuvanted recombinant protein-based vaccine candidate. https://www.sanofi.com/en/media-room/press-releases/2020/2020-09-03-07-0....