With new vaccines, US racing against coronavirus mutations

A new coronavirus vaccine from Johnson & Johnson appears to be another promising tool in the fight against COVID-19, but the U.S. is racing against problematic virus mutations that could throw a wrench into the system.

Johnson & Johnson on Friday announced its vaccine candidate offered strong protection against severe COVID-19 and prevented hospitalization and death, which could provide a major boost to the country’s overwhelmed health system. 

The company is expected to file for emergency use authorization with the Food and Drug Administration (FDA) next week, potentially giving the U.S. a third vaccination to use against the virus. 

Vaccine experts praised the results, and cautioned against comparing them head-to-head with the current Moderna and Pfizer vaccines already in use.

“The goal of this vaccine, it’s to keep you out of the hospital, keep you out of the ICU and keep you out of the morgue. Obviously it’s not fun having a mild infection, but it’s not a burden to the health care system,” said Paul Offit, director of the Vaccine Education Center at Children’s Hospital of Philadelphia.

Anthony Fauci, the country’s top infectious diseases expert, said during a White House briefing Friday that the Johnson & Johnson results had “important potential and real implications.”

“This is a single-shot vaccine in which you start to see efficacy anywhere from seven to 10 days following the first and only shot,” Fauci said. “It is very, very good with regard to cold chain requirements … it is inexpensive and the company is capable of making doses in the billions.”

Experts say the best way to prevent further mutations and more potentially dangerous variants is for people to get vaccinated as quickly as possible, because more immune people means less chance for the virus to spread and evolve. 

With its relatively easy storage requirements and ease of administration, the Johnson & Johnson vaccine could be a real help, if it is given to enough people fast enough. 

But its efficacy was limited against different strains, dropping from 72 percent in the U.S. to 66 percent in Latin America, all the way down to 57 percent in South Africa, where a new coronavirus variant is prevalent.

The gap in efficacy is important. Novavax, a Maryland-based vaccine manufacturer, said Thursday that its vaccine was nearly 90 percent effective in the U.K. but just 49 percent effective in South Africa. 

The company is still gathering data in clinical trials though, and is not ready to file for authorization. 

Vaccines can be updated to specifically address that variant, and mRNA vaccines — which include the Pfizer and Moderna products — are particularly suitable for updating. 

However, the process for rolling out an updated vaccine or even a booster can take time, a valuable commodity in the middle of a raging pandemic. There would need to be more clinical trials and regulatory approval.

For example, Novavax said Thursday it is developing “new constructs against the emerging strains,” including possible booster shots, but it won’t begin clinical trials until the second quarter of this year.

Jesse Goodman, a professor of medicine and infectious diseases at Georgetown University and former FDA chief scientist in the Obama administration, said he thinks drug companies might only need a “few months” to shift production once the decision is made.

Goodman said he is aware a new variant could become the dominant strain in the time it takes a company to even start producing a vaccine against it, so it’s important to begin preparations now.

“You don’t want to shift production unless you’ve got a strong compelling reason. We can’t say if this will be required for this South African variant yet, but I think what we can say is we need to be prepared for that or other eventualities,” Goodman said.

Fauci on Friday noted the different mutations have “clinical consequences” that will need to be addressed.

The strain first found in the U.K. is projected to be the dominant one in the U.S. by March, but Fauci said it’s not clear what will happen with the South African strain.

“This is a wake-up call to all of us,” Fauci said. “We will continue to see the evolution of mutants so we … will have to be nimble to be able to just adjust readily to make versions of the vaccine that actually are specifically directed towards whatever mutation is actually traveling at any given time.”