No ‘guarantee’ vaccine will be ready this year

Emergent Biosolutions CEO Robert Kramer told CNBC Monday it is uncertain that a coronavirus vaccine can be available by the end of the year to fulfill President Donald Trump’s wishes.

The specialty biopharmaceutical company is collaborating with drug giant Johnson & Johnson on a Covid-19 vaccine candidate, which Johnson & Johnson hopes will receive emergency use authorization in 2021.

“Nobody can guarantee anything,” Kramer said in a “Mad Money” interview with Jim Cramer. “We’re here, as well as all of our partners and collaborators, doing everything we can to make sure that a vaccine and treatments are available as soon as possible.”

Trump said during a Fox town hall on Sunday that he was confident a vaccine for the deadly disease would be developed by the end of 2020. While it typically can take as many as 10 years to develop a vaccine, health experts, including officials a part of the White House’s coronavirus task force, have said that it will take between 12 to 18 months to have a solution ready for public use. 

“We are very confident that we are going to have a vaccine at the end of the year, by the end of the year,” Trump said at the town hall. “We think we are going to have a vaccine by the end of this year, and we are pushing very hard.”

Kramer said it is possible to cut down the timeline to develop a solution, echoing the words of Dr. Anthony Fauci, the director of the National Institute of Allergy and Infectious Diseases and lead health official on Trump’s coronavirus task force.

While the timetable to have a vaccine may take up to 18 months, Fauci told CBC News in April that it’s possible to “shave a couple months off that,” but said it’s best not to “over-promise.”

The U.S. Food and Drug Administration must play a role in speeding up the process, Kramer said. Emergent Biosolutions could begin producing millions of doses of vaccine “at risk” during Phase 2 of clinical trials when preparing to do a data read out, he said.

“When that data is read and the FDA can get comfortable with the safety and efficacy of that data, those doses can be released to the public under some type of emergency use authorization,” he explained.”That’s where the shortening of the timeline could happen.”

As of April, 70 coronavirus vaccine candidates were under development as companies rush to find a solution to slow the global spread of the virus. Just three of the dozens of potential preemptive remedies are currently going through human tests.

Johnson & Johnson plans to begin the Phase 1 clinical trial for its vaccine candidate in September. The partnership with Emergent Biosoutions, worth about $135 million, calls for Emergent Biosolutions to mass produce the countermeasure. Johnson & Johnson’s goal is to manufacturer 1 billion doses of vaccine.

“We are all in this together to literally accelerate wherever we can the development and the clinical timeline,” Kramer said. “The hope is that we can look at this creatively. We can look for ways to shorten that time frame and make significant number of doses available to the public as soon as possible.”

Johnson & Johnson, however, is not the only vaccine developer that Emergent Biosolutions is working with. The Gaithersburg, Maryland-based manufacturer also has development and manufacturing agreements with Vaxart and Novavax for their experimental vaccine candidates.

“We’re here, Jim, to support any number of vaccine candidates with the overall objective or goal of making sure that we get at least one — if not several — of these vaccine candidates through a phase 1 [and]  through a phase 2,” Kramer said. “We have the capability to manufacture those candidates at a scale where we could potentially make hundreds of millions of doses of those available to the public as soon as possible.”

Disclosure: Cramer’s charitable trust owns shares of Johnson & Johnson.