With winter around the corner, you might be wondering just where we stand in regard to the COVID-19 pandemic. On Monday, a former U.S. Food and Drug Administration commissioner warned that we are in the middle of the seventh inning, but this is no game and we have no time for a stretch.

Dr. Scott Gottlieb told CNBC’s “Squawk Box” that the increases in coronavirus cases probably will continue this fall without a vaccine or other treatments. Many experts also have warned of a third surge coming this winter as the annual flu virus also spreads.

The world tally reached 40 million coronavirus cases on Monday, Johns Hopkins University reported. The World Health Organization tally was at 39.9 million on Monday.

“We’re going to get through it,” said Gottlieb, who left the FDA in April 2019. “We’re probably in the seventh inning of the acute phase of this pandemic right now, but the hardest part is probably ahead.”

The U.S. reported its highest number of new coronavirus cases (69,000) since July on Monday, with the death toll reaching at least 218,600, according to Johns Hopkins. “There’s really no backstop here,” Gottlieb said.

Gottlieb, a Pfizer board member, said any vaccine in development would not have an impact until 2021, especially with a process that requires application for emergency use. Even if that happened by late November, he told CNBC, the review would take two to four weeks and then reach only “a very select population: people who are elderly and high risk.” Even then, protective immunity would not take effect until February or March, he said.

In recent weeks, there have been 40,000 to 50,000 new coronaviruses daily. That is concerning to medical experts, considering that the cooling weather will send people indoors where they will be around others more often.

“We need to pay more attention to this,” Emory University professor and infectious disease specialist Dr. Carlos del Rio told CNBC. “We seem to forget that we’re making progress, we’re doing better, and then we kind of let go and we go back again.”

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