THE FOOD AND DRUG Administration on Monday told vaccine makers that large clinical trials for authorized shots that are modified to address coronavirus variants are not necessary. Instead of lengthy trials where the vaccine would be compared to a placebo, new guidance from the FDA suggests smaller trials that “compare a recipient’s immune response to virus variants induced by the modified vaccine against the immune response to the authorized vaccine.” Several companies have announced they will work on shots to address the new coronavirus variants. The FDA’s guidelines would shorten the process from getting a vaccine developed to getting it into people’s arms.
“We know the country is eager to return to a new normal and the emergence of the virus variants raises new concerns about the performance of these products,” FDA acting Commissioner Janet Woodcock said in a statement. “By issuing these guidances, we want the American public to know that we are using every tool in our toolbox to fight this pandemic, including pivoting as the virus adapts.” Woodcock said that the change does not necessarily mean updates to vaccines are needed to address the variants. Preliminary data has suggested that current vaccines work against the variant first found in the U.K., but efficacy is reduced when up against the variant first found in South Africa, though antibody levels could still be high enough to offer protection.
2nd Case of Virus Variant Found on Long Island, Though Positivity Rate is Falling
A second case of the South African variant of COVID-19 has been confirmed in Nassau County, Gov. Andrew M. Cuomo said Tuesday, though overall positivity levels in tests for the virus continued to decline statewide. Health officials also confirmed 18 new cases of the U.K. variant statewide, bringing the total to 154, he said. The state reported Long Island’s first case of the South African variant on Sunday, with Nassau County confirming that an individual living in Glen Head contracted it.
While some experts believe the new variants spread more rapidly than the dominant COVID-19 strain, more research is needed to determine whether they are more deadly or less responsive to the vaccines. Dr. Bruce Polsky, chairman of Medicine at NYU Langone Hospital-Long Island and an infectious disease specialist, said he is “very worried” about the second confirmed case of the South African variant.