A vaccine for COVID-19 is said to be close, but questions, challenges remain

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HUNTSVILLE, Ala. — Health officials say returning to a normal way of life will require a vaccine.    

The Centers for Disease Control recently notified states to begin initial planning for a vaccine. News 19 asked the Alabama Department of Public Health Tuesday about the timing and possible distribution of a vaccine. An ADPH spokeswoman said they have had discussions — but details are still fluid.

President Donald Trump said Tuesday the U.S. could have a vaccine in a matter of weeks, maybe 4 to 8 weeks. The president stressed he has sped up the approval process amid the pandemic.

But it is still not a simple task as researchers are still trying to understand the virus.

“The challenge with COVID-19 is that it is a brand-new infectious syndrome. It was first described in November of last year,” said Dr. Richard Spera, an infectious disease specialist and chief medical officer for Alimetrix in Huntsville.

CDC documents urge states to prepare for two possible vaccines that are administered twice, 21 or 28 days apart. The documents suggest there could be 3 million dosages by the end of October, 30 million by the end of November and 35 to 45 million by the end of December.

The CDC also advises that state’s prioritize health workers and people working and living in nursing homes. Then government advisors will help prioritize who’s next — likely physically vulnerable populations.

Vaccine trials normally take years.

“In order for something to be approved for use in our country by the FDA, it has to be shown it is effective,” Spera said, “in other words does it work and secondly does it hurt anything?”

Spera said vaccine testing has to show a statistically significant benefit to the patient or, measure significantly significant harm to the patient.

How long does that take?  

 “A clinical trial is an experiment and you don’t know what’s going to happen until you do it,” he said.

Spera said the companies leading the vaccine development have long experience with testing and developing methods to determine how many people are needed to determine a vaccine’s effectiveness.

The CDC says its expects the Food and Drug Administration will either license the vaccine, or, give it an emergency use authorization.

How do they make that call, amid a pandemic?

We decide this as a society, what is an acceptable level of risk vs. the benefit.

Spera said even if a vaccine is ready today, there are production and distribution challenges to resolve. He said there isn’t one single health system in the U.S., but different systems in every state and territory. Large states with rural populations will present challenges for distribution, while larger urban hospitals like Huntsville Hospital and UAB, should be well-equipped to handle the task, Spera said.

“So, it’s going to be based on how efficiently each state or territory can organize things,” he said.

We asked Gov. Kay Ivey’s office Tuesday about vaccine preparations.

“Conversations regarding a possible vaccine have already begun on our end. We are continuing to receive federal guidance, and as we have updates, we will certainly share that,” the governor’s spokeswoman told News 19.

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