After a six-month review, the Food and Drug Administration said on Thursday that it needed more information on a Zika vaccine, but did not object to its use for prevention of the mosquito-borne virus.
The drug, called Covid-19, was developed by Mydicar (Frontera Abrilaria Yubico), the pharmaceutical unit of Abbot Laboratories, which is now exploring its strategy for seeking FDA approval of the vaccine. Mydicar was granted a license to market the vaccine for five diseases in 2012: Zika, dengue, West Nile virus, Yellow fever and yellow fever virus.
Peter Marks, the deputy commissioner for biologics, said in a release that Covid-19 was given a priority review, and that he planned to meet with Mydicar in December to discuss how the vaccine was tested.
When asked if Covid-19 should require a second round of trials, he said, “I’m not making recommendations as a scientist at the agency, but it would be worth considering a second trial if there were additional questions that needed to be clarified.”
The review team at the FDA, which is known for taking a cautious approach to new products, concluded that the vaccine would not cause hypersensitivity, but it also asked that further safety data be gathered from clinical trials.
“We also are looking at what additional Phase 2 clinical trial information is needed to meet our standards, so that all the parties understand the package that is being prepared,” he said.
Although Covid-19 does not provide immunity to disease, scientists at Mydicar’s factory in Puerto Rico who met with the FDA team agreed that the vaccine could work as a preventive measure.
Dr. Lloyd Schwartz, a senior biologics scientist at Mydicar, said the company had made antibodies from the virus that would be functional in the vaccine, which he characterized as “a very novel approach.”
The Biotechnology Industry Organization, which represents drugmakers, had in August voiced concerns that the company was not adequately testing the vaccine for it to be recommended for human use.