European Union’s drug regulators approved storage of Pfizer/BioNTech's coronavirus vaccine at normal freezer temperatures for a short period of time. This is based on data showing the stability at the recommended temperatures in standard pharmaceutical freezers. According to a press release by Pfizer, “The new data is a testament to the companies’ ongoing commitment to developing this vaccine further and collecting data in order to support broader and more flexible vaccine distribution and inoculation”.
Ugur Sahin, CEO and Co-founder of BioNTech said, “From the beginning our goal was to make our vaccine broadly available to people around the world. This approval by the EMA will enable us to access important additional channels to distribute and administer our vaccine. It comes at an important point in time, as governments now have more flexibility to move from inoculations in vaccination centers to a more decentralized vaccine roll-out through local doctors and general practitioners to accelerate our path out of the pandemic”.
The Pfizer-BioNTech vaccine, which uses mRNA technology, was first approved in the UK. Its inability has been a major hurdle for distribution efforts. Vaccine doses are shipped in specially-designed containers that must be topped up with dry ice every five days and once it arrives at a clinic, it can be kept in a fridge for only five days. These stringent requirements have complicated vaccine rollout.
Albert Bourla, Chairman and Chief Executive Officer, Pfizer said, “We appreciate the collaboration with the EMA and other regulatory agencies around the world as we work to ensure our vaccine can be shipped and stored under increasingly flexible conditions”. He added, “This new storage option in Europe will help make the vaccine even more accessible to people across the continent, another important step as we continue our global fight against this virus”.
In another significant development, Pfizer has initiated the Phase I trial of an anti-COVID-19 pill that could be given to patients showing early signs of illness. According to Pfizer, the pill could be used in the early treatment of COVID-19 disease and to address future coronavirus threats. Pfizer has said that the oral candidate PF-07321332 has shown positive signs in lab tests against SARS-CoV-2. Pfizer has said that the potential oral therapy will complement vaccines and could be used on patients who have been inoculated but become COVID-19 positive.
As per Pfizer, the Phase I trial of the potential oral candidate PF-07321332 is being conducted in the United States. The preclinical studies have demonstrated that the drug holds the potential to stop the virus from replicating and developing into a more serious infection. The structure of PF-07321332, together with the preclinical data, will be shared in a COVID-19 session of the Spring American Chemical Society meeting on April 6, Pfizer said.