NIH’s Collins Lauds AstraZeneca’s COVID Vaccine Trial Halt

In a Senate hearing yesterday, National Institutes of Health Director Francis Collins applauded AstraZeneca’s decision to halt its phase 3 COVID-19 vaccine trial due to an unexplained illness — and said the incident should reassure the public that companies are not compromising when it comes to the safety of their vaccine candidates.

The drugmaker suspended trials of AZD1222 on Tuesday because of an “unexplained illness” that occurred in the UK trial (DID, Sept. 9).

Collins told the Senate Committee on Health, Education, Labor and Pensions that the incident serves as “exhibit A” for not compromising on the safety of a COVID-19 vaccine.  He noted that clinical holds in large-scale trials are “not at all unprecedented,” and that AstraZeneca took “the best approach” in handling the trial.

If the illness is found to be a consequence of the vaccine, the doses that have already been manufactured will be thrown away, he told the lawmakers.

Although the hearing’s agenda included all vaccines and public health, Collins and Surgeon General Jerome Adams used the opportunity to ease concerns about COVID-19 vaccines and to address concerns from committee members about distribution and political pressure to accelerate the review process.

President Trump has accused federal officials of deliberate delays aimed at slowing a decision on a vaccine until after the Presidential election on Nov. 3 (DID, Aug. 31). Sen. Bernie Sanders (I-Vt.) urged Collins and Adams to tell Trump to “get out of science” and let scientists ensure that any vaccine is safe. Collins assured Sanders that “science and science alone” will guide decisions on COVID-19 vaccines, “otherwise I’ll have no part in it.”

Adams added that “no shortcuts” are being taken to approve a vaccine, and that he and his family will be “the first in line” to get one when its available.

Collins expressed “cautious optimism” that one of the six vaccines being tested in trials under Operation Warp Speed may emerge as safe and effective by the end of the year, but he emphasized that no vaccine will be reviewed by the FDA until an independent data and safety monitoring board reviews data from ongoing trials.

He also noted that the nine leading COVID-19 vaccine makers have pledged not to file for approval of a vaccine until it meets certain safety and efficacy standards (DID, Sept. 8).

Sen Maggie Hassan (D-N.H.) questioned why the companies would take the unprecedented step of issuing a pledge.  Adams did not respond directly to her question, but he did note that he and Collins had been on the phone to the companies to reassure them about the independence of the review process.

Adams also noted that HHS is working with states and advisory committees on how to distribute COVID-19 vaccines, which he said will likely be “logistically the most difficult vaccine we’ve ever deployed.”

Adams did not elaborate, but Collins noted that the challenges include how to store the vaccines, since many of them require ultra-cold temperatures. For example, he noted that Pfizer’s vaccine would need to be stored at -70 degrees Celsius. There likely would be a shortage of freezers that would be needed for a large-scale, nationwide distribution.

Adams also told the panel that the department is working with the National Academy of Sciences and other advisory groups on who should be vaccinated first. While no final recommendations have been made, he said it is agreed that healthcare workers should get the vaccine first, followed by those who are considered most vulnerable to the virus. — Jordan Williams