Their COVID-19 vaccine, Covaxin, which has already been approved under emergency use authorization from the Indian drug regulator, is now under tests in COVID-19 patients infected with variants B.1.1.7 (n=2), B.1.351(n=2), B.1.1.28.2(n=2), and B1 (n=11). The results showed that the vaccine had the potential to neutralize the B.1.617. The findings are promising and may pave the way for the vaccine to the US healthcare market.
Why are uniQure Shares Shooting Up Today?
After the USFDA had put a clinical hold on the clinical trial investigating uniQure’s gene therapy for Hemophilia B, the company began the comprehensive investigation to prove the innocence of its therapy.
During the trials, a patient who had received the investigation gene therapy AMT-061 in the HOPE-B (NCT03569891) trial was diagnosed with hepatocellular carcinoma (HCC), however, the company announced that the diagnosis was in no way the consequence of gene therapy.
As per the announcement, the patient had multiple risk factors associated with HCC, such as a 25-year history of hepatitis C and hepatitis B, which have been associated with approximately 80% of HCC cases.
Thus, after all the issues were addressed by the company, it was concluded that the adeno-associated virus (AAV) vector used in the gene therapy did not lead to that case of liver cell cancer the FDA gave the company to continue the Hope-B trial.
Finally, the USFDA and CDC have lifted the restriction they had put on Johnson & Johnson COVID-19 vaccine announcing that the benefits outweighed the risks.
Owing to the cases of “rare and severe” type of blood clot known as cerebral venous sinus thrombosis (CVST) in combination with low levels of blood platelets (thrombocytopenia), the distribution of the vaccine was put on pause.
Initially, the vaccine had an advantage over the other two vaccines namely by Pfizer and Moderna, due to its logistics advantage as it needs not be frozen and requires only one dose. Although, the snags did halt its speedy journey, however, it seems the road is clear now.
Sanofi Shakes Hands with Moderna to Make COVID-19 Vaccines for the US
As the global demand for the COVID-19 vaccine continues, pharmaceutical companies are expanding their manufacturing capacities to accommodate and fulfill the demand. Following the course, Sanofi announced a collaboration with Moderna to bolster the number of authorized vaccines while simultaneously propelling its R&D towards the development of its own preventative medicines.
The tie-up between the companies marks the third such kind of vaccine manufacturing deal Sanofi has struck. The company is already in similar kinds of collaborations with J&J and BioNtech.
A Sanofi plant in Frankfurt, Germany, is set to provide 125 million doses of the Pfizer-BioNTech vaccine that will be supplied to the European Union, while another of its site in France, will produce 12 million doses per month of the Johnson & Johnson COVID-19 vaccine.
