Pfizer says it is relatively simple to rejig the formulation and manufacturing infrastructure for its approved mRNA vaccine in the case of COVID-19 variants.
Following a year that saw Pfizer bring to the US and Europe the first vaccine against COVID-19, the firm has raised its production targets for 2021 from 1.3 billion doses to 2 billion doses, and expects to deliver 200 million doses to the US by end of May.
“Because of the dire need to vaccinate more people, we have explored innovative plants to increase the number of doses we are able to produce globally by the end of 2021,” CEO Albert Bourla told stakeholders yesterday.
Image: iStock/Jakub Rupa
While he did not elaborate on this during the conference call, the firm has expanded its manufacturing network. Recently, it struck deals with fellow Big Pharma companies Novartis and Sanofi to help scale up production. Meanwhile, Pfizer is modifying production processes at a major manufacturing site in Puurs, Belgium to help increase volume, and a facility acquired from Novartis by partner BioNTech in Marburg, Germany will further aid scale up.
Variants
But with the threat of virus mutations – such as those already seen with the South Africa variant and UK variant spikes – the efficacy of the vaccine could be affected and therefore such scale up could end up being futile.
However, Bourla did not appear phased. Pfizer is carrying out studies on the vaccine against variants and is awaiting data on neutralization of an engineered SARS-CoV-2 with a full set of mutations from the spike of the South African variant.
And in the worst-case scenario, he remained confident the vaccine could be quickly adapted to deal with variants due to the nature of the vaccine’s platform – messenger RNA (mRNA).
“One of the reasons Pfizer and BioNTech chose to utilize an mRNA platform is because of the potential for the flexibility of the technology in comparison to traditional vaccine technologies. This flexibility includes the ability to alter the RNA sequence in the vaccine to potentially address new strains of the virus if one were to emerge, but is not covered by the current vaccine,” he said.
While he admitted “nothing is simple in biology, when you speak about highly complicated processes,” he said relatively it “is really a very, very simple process in terms of manufacturing and in terms of actually developing it,” if needs be.
While this would require additional development work and regulatory submissions and approvals, Pfizer and BioNTech are already “preparing for such a possible scenario by working closely with regulatory agencies as well as relevant scientific bodies to enable vaccine technical committees to review data and make appropriate updates to recommendation.”
Bourla is not the first to cite the relative simplicity of manufacturing mRNA compared with traditional vaccines. Moderna Therapeutics, which has also received regulatory approval for an mRNA vaccine against COVID-19, has previously described the scale of production for its vaccine as quite small because its manufacturing is an aqueous, cell-free phase enzymatic reaction.
“Traditional biotechnology requires these massive bioreactors, because there’s a limited space into which you can crowd cells before they get really, really unhappy. But enzymatic reactions actually like to be dense – in fact, they become more efficient,” Tal Zaks, chief medical officer at Moderna, said last September.