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July 29, 2020: A promising vaccine candidate is being developed in partnership with Pfizer (USA) and BioNTech (Germany). This particular vaccine candidate targets the full length of the “spike” glycoprotein S (the part of the virus that attaches to cells enabling viral entry and eventual replication), which is the target of virus neutralizing antibodies generated by the immune response. This vaccine has a mechanism of action that is different than any human vaccine to date. The vaccine introduces a piece of genetic material (messenger RNA (mRNA)) into host cells whereby the host cells use that material to make a protein (in this case the SARS-CoV-2 spike protein) and then display that protein on their surface. This triggers an immune response to the protein which mimics the effective (or neutralizing) immune response that an infected person should mount. Recent results showed that the vaccine caused the production of protective IgG antibodies in increased concentrations both when given higher doses and after a second dose, all with a mild side effect profile.

Given their early clinical success, the two companies have announced they are proceeding to Phase II/III trials with 30,000 subjects worldwide set to receive two doses 4 weeks apart. If this larger study shows equal efficacy and safety, the U.S. Food and Drug Administration (FDA) has already given this vaccine Fast Track designation for approval, and the Trump administration has awarded Pfizer a $1.9 Billion contract to purchase up to 100 million doses of the vaccine. Furthermore, Pfizer estimates that they can produce over 1 billion doses for worldwide use by the end of 2021.

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