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.
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, two days after filing for conditional market authorization.
LONDON – South Africa has decided against using the 1 million doses of Astrazeneca plc’s COVID-19 vaccine already in the country to start the rollout of its national vaccination program, in favor of opening a phase IIIb study of Johnson & Johnson’s single shot product. “Over the next few days, we expect to announce a plan to expedite vaccination using [J&J’s] investigational vaccine in health care professionals in South Africa,” said Glenda Gray, CEO of the South African Medical Research Council and chair of the country’s research committee on COVID-19.
LONDON – A follow-up study of participants in the phase II/III U.K. trial of Astrazeneca plc’s COVID-19 vaccine has shown it remains effective against the new B.1.1.7 variant of SARS-CoV-2.
LONDON – The U.K has started the world’s first trial alternating an adenoviral vectored COVID-19 vaccine with one that delivers the virus spike protein instructions encoded in messenger RNA. The heterologous prime boost trial will recruit 820 participants into an eight-arm study comparing different combinations of the Astrazeneca plc/Oxford University and Pfizer Inc./Biontech SE vaccines, administered in a different order and at different intervals.
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