Reporting on COVID vaccines during the first stages of the pandemic, back in August '20, a few challengers to the global pharmaceutical firms stood out
Next to Australia's CSL
Our comment, at the time, suggested so much
Niche vaccine specialist Valneva of France
Adopting a traditional approach, the vaccine is 'grown' on a sample of the actual disease that has been inactivated and used to simulate an immune response with creating infection, one of the oldest ways to make vaccines
The vaccine is produced via a vero-cell platform, which leverages the manufacturing technology of the company’s licensed Japanese encephalitis vaccine Ixiaro
The company stated that its COVID vaccine 'VLA2001 is currently the only whole virus, inactivated, adjuvanted vaccine candidate against COVID-19 in clinical trials in Europe."
Investment opportunity beckoning... or picking pennies in front of a steamroller....?
In a singular sequence of events, the UK government served notice to terminate the € 1.4 billion ($1.98 billion) contract for 100 million doses to be manufactured in Scotland on Sept. 13, 2021 over allegations of unspecified breach of the agreement
A month later, on Oct. 18, 2021, the company announced the positive results of a stage 3 trial
With a trial involving more than 4 000 participants aged 18 and older, Valneva touted higher levels of neutralizing antibodies when compared with AstraZeneca’s shots
In a quick reversal of fortunes, the company's shares
However, analysts were quick to point out that
- it will be hard for Valneva to manufacture the billions of doses that producers of the mRNA vaccines (such as the Pfizer-BioNTech) and adenoviral vaccines (such as AstraZeneca) can produce, because of the need to grow large quantities of live samples of the disease
- if novel variants require new vaccines, the traditional approach taken by Valneva will not have the flexibility of the mRNA process and take longer to deliver
- in the 'traditional' cell culture, mutations which are not representative of the original virus cannot be excluded
Valneva's vaccine is likely to be filed in the countries where AstraZeneca's vaccine was approved (which could exclude the U.S.)
Its traditional approach, tried and trusted for the polio vaccine since the 1950's, may actually answer concerns of the anti-vaccine doubters
Target markets could be the UK, although reactivation of the original contract remains in doubt, European countries and, most probably, less advanced countries
A major advance purchase agreement with the European Union could be difficult on the back of its mega deal with Pfizer and BioNTech worth a total of 1.8 billion doses
Developing nations, however, are dramatically short on the vaccine supply targets of more than 2 billion doses by the end of 2022
The international consortium program COVAX, underwritten by advanced countries, has been downsizing its commitments by more than 1 billion doses because of production issues of a key U.S.. supplier, assumed to be Novavax
Scaling of the complex vaccine production process will be key to the credibility of Valneva's promising vaccine with the world's large sponsors, and especially with COVAX
By outsourcing its Covid-19 vaccine to a contract manufacturing organization, Valneva could respond to demand for additional capacity of its Covid-19 vaccine, according to the firm's chief medical officer Dr Juan Carlos Jaramillo
The challenges of Valneva are real on many fronts and its inactivated virus vaccine could be expected to compete with vaccines of this technology catering to China (Sinopharm
An investment opportunity to be weighed