Covid-19 roundup: CDC advisory committee delays priority distribution vote; EU reportedly indemnifying vaccine makers
A federal committee that advises the CDC was expected to hold a vote Tuesday on a plan regarding the distribution for initial doses of approved Covid-19 vaccines. But that vote has been scrapped.
The Advisory Committee on Immunization Practices, or ACIP, won’t be voting until the committee members learn more about which vaccines become available first, the Wall Street Journal reported. The vote could potentially wait until a specific vaccine is authorized before recommending how to dole out the first doses.
Usual procedure dictates that the committee vote only after vaccine candidates have been cleared by regulators. A CDC spokesperson confirmed to the Journal that no vote was scheduled despite prioritization for early dosing appearing on the committee’s agenda online.
Likely candidates for the first individuals to receive Covid-19 vaccines are high-risk populations, healthcare workers and employees in industries such as food and agriculture.
Any prioritization plan could assist states crafting their own distribution programs. Late last month, CDC director Robert Redfield wrote a letter to governors telling states to be ready for potential vaccine distribution by Nov. 1.
Distributors are facing several challenges, not only regarding the actual handing out of vaccines but finding proper storage facilities. Some mRNA candidates, like the ones being developed by Moderna and Pfizer, must be stored at temperatures well below freezing — potentially at minus-80 degrees Celsius.
Europe to reportedly provide some liability shields to drugmakers
After seeking protection from liability in Europe while producing Covid-19 vaccine candidates, several big drugmakers will now reportedly be compensated should their vaccines cause unexpected side effects.
The European Commission is providing confidential liability clauses in its contracts with pharma companies, Reuters reported Tuesday morning, and has already included such provisions in deals with AstraZeneca and Sanofi. The bloc is still negotiating similar conditions with other vaccine makers for advance purchase of their vaccine candidates.
A spokesperson for the commission told the wire service that advance purchase deals “provide for Member States to indemnify the manufacturer for certain liabilities incurred under specific and strict conditions,” but “liability still remains with the companies.”
Vaccine producers have been pushing the EU to provide full liability protection, something the union has been reluctant to do. Last month, the European pharma industry’s vaccines lobby, Vaccines Europe, circulated a memo among its members citing the “inevitable” risks that come with accelerated vaccine development.
Also on Tuesday, the Russian government claimed it will be taking on some of the liability for its companies’ vaccine candidates itself rather than requiring buyers to take on the full risk, per a separate Reuters report. That approach differs from how the US is tackling things, as liability has been shifted fully to the government.
China-backed Sinovac starts PhIII in Turkey
Sinovac has started a new Phase III trial for its Covid-19 vaccine candidate in Turkey, the company announced Tuesday.
The announcement did not specify exactly when the trial began, only that it has “recently commenced” evaluating whether the Chinese company’s CoronaVac product is safe and effective. Sinovac’s trial will be randomized, double-blinded and placebo-controlled, seeking to enroll 1,300 healthcare workers and 12,000 members of the general Turkish population.
In the company’s Phase I/II trials that were conducted in China earlier this year, the vaccine candidate showed immune responses in more than 90% of its 600 volunteers, Sinovac said.
Back in July, the Chinese government approved CoronaVac for emergency use, giving doses to some medical professionals and border officers. That information didn’t become public, however, until late August, when a government health official disclosed the authorization in an interview with state-owned media. Reuters later confirmed that one of the products mentioned in the interview was Sinovac’s candidate.