White House Has Promised To Deliver A Vaccine ASAP, But What Happens If One Isn’t Proven Safe?
Some experts worry that the intense political pressure for a vaccine by the end of the year might lead the Trump administration to rewrite safety rules. In other vaccine news: trials, supply agreements, costs and more.
White House Pressure For A Vaccine Raises Risk The U.S. Will Approve One That Doesn’t Work
President Donald Trump has promised that there will be a coronavirus vaccine before the year is out. But public health experts are growing increasingly worried that the White House will pressure regulators to approve the first vaccine candidate to show promise — without proof that it provides effective, reliable protection against the virus. Drugmakers and health agencies have already begun rewriting the rules of vaccine research, launching candidates into clinical trials at record speed in search of a pandemic-ending shot. Data on the vaccines’ safety is already trickling in. But no candidate is yet ready for the final step of the development process: a months-long trial in tens of thousands of volunteers to prove once and for all whether the shot works. (Owermohle, 6/15)
The New York Times:
Guaranteed Ingredient In Any Coronavirus Vaccine? Thousands Of Volunteers
Not long after researchers completed their work with mice, guinea pigs, ferrets and monkeys, Human Subject 8, an art director for a software company in Missouri, received an injection. Four days later, her sister, a schoolteacher, became Subject 14. Together, the sisters make up about 5 percent of the first ever clinical trial of a DNA vaccine for the novel coronavirus. How they respond to it will help determine the future of the vaccine. If it proves safe in this trial and effective in future trials, it could become not only one of the first coronavirus vaccines, but also the first DNA vaccine ever approved for commercial use against a human disease. (Murphy, 6/13)
Moderna COVID-19 Vaccine Appears To Clear Safety Hurdle In Mouse Study
A series of studies in mice of Moderna Inc’s COVID-19 lent some assurance that it may not increase the risk of more severe disease, and that one dose may provide protection against the novel coronavirus, according to preliminary data released on Friday. Prior studies on a vaccine for SARS - a close cousin to the new virus that causes COVID-19 - suggests vaccines against this type of virus might have the unintended effect of causing more severe disease when the vaccinated person is later exposed to the pathogen, especially in individuals who do not produce an adequately strong immune response. (Steenhuysen, 6/12)
AstraZeneca Agrees To Supply Europe With 400 Million Doses Of COVID-19 Vaccine
AstraZeneca Plc has signed a contract with European governments to supply the region with its potential vaccine against the coronavirus, the British drugmaker’s latest deal to pledge its drug to help combat the pandemic. The contract is for up to 400 million doses of the vaccine, developed by the University of Oxford, the company said on Saturday, adding that it was looking to expand manufacturing of the vaccine, which it said it would provide for no profit during the pandemic. The vaccine is still in clinical trials. If the trial results convince regulators the vaccine is safe and effective, deliveries would be expected to start by the end of 2020. (6/13)
What’s At Stake For Pharma In Its Space Race For A Covid-19 Vaccine
The Trump administration’s move to pick five companies as finalists in the quest to develop a vaccine for the novel coronavirus has set off a pharmaceutical Space Race in the industry. And for each of the five firms involved, there’s a lot at stake: reputation, a boon to national pride, maybe even a rebuke to voluble skeptics. (Garde, 6/15)
Sinovac Says Its Covid-19 Vaccine Generated Immune Responses
Sinovac Biotech announced preliminary study results on Saturday showing its experimental Covid-19 vaccine generated immune responses in patients and was safe — early data that suggest it might protect people against infections with the novel coronavirus. The Beijing-based drug maker’s vaccine, called CoronaVac, induced neutralizing antibodies in “above 90%” of people who were tested 14 days after receiving two injections, two weeks apart. There were no severe side effects reported, the company said in a statement. (Feuerstein, 6/14)