In a Feb. 17 update to its guidance on managing clinical trials during the COVID-19 pandemic, the U.K.’s Medicines and Healthcare Products Regulatory Agency (MHRA) said all sponsors of ongoing clinical trials for indications other than treatment or prevention of COVID-19 are required to evaluate the impact a COVID-19 vaccine may have on the trial.
LONDON – The EU is taking concerted action to detect new variants of SARS-CoV-2, investing €225 million (US$270 million) to increase viral genome sequencing to 5% of positive cases across Europe, and to carry out research on their evolution and transmissibility.
PERTH, Australia – With the first COVID-19 vaccine ready to be launched in Australia, the Therapeutic Goods Administration has released guidance on its pharmacovigilance plan to track real-world safety data and adverse events following immunization.
The U.S. House Energy and Commerce Committee needed two days of hearings to get through a spending measure that provided the FDA with $500 million for its part in the government response. The CDC would receive $7.5 billion for vaccine distribution and tracking, all developments that ran parallel to an announcement that another 200 million doses of vaccine will be delivered by the end of July at a cost of $3.7 billion.
Limited manufacturing capacity, supply chain disruptions and a dearth of personnel with specialized skills are all challenges vaccine makers are facing as they race to produce contracted quotas of COVID-19 vaccines that were developed and authorized in record time.
LONDON – The EMA has requested all COVID-19 vaccine developers to investigate if their products offer protection against new variants of SARS-CoV-2 and to submit the relevant data.
DUBLIN – Spybiotech Ltd. raised $32.5 million to move into clinical trials its first in-house vaccine program based on its Spycatcher/Spytag protein conjugation technology. The company is gearing up to start a phase I trial of a vaccine directed against cytomegalovirus (CMV) early next year.
Under threat of emerging variants, the EU is taking to heart lessons learned so far in the global COVID-19 pandemic to accelerate the review of vaccines, improve data sharing from clinical trials and address the difficulties inherent in the mass production of vaccines that may contain up to 400 components.
HONG KONG – Sinovac Biotech Ltd.’s COVID-19 vaccine, Coronavac, received conditional approval for use by the general public from China’s National Medical Productions Administration (NMPA), two days after filing for conditional market authorization.
The Biden administration said it will use the U.S. Defense Production Act to grapple with the COVID-19 pandemic in a plan that includes a large increase in vaccine purchases. Also on tap is an increase in production of at-home test by six companies in addition to Ellume Ltd., of Perth, Australia, which will ship more than 8 million of their tests to the U.S. by the end of the year.