Development Of COVID-19 Vaccine And Treatment 'Have To Happen Side By Side' –

The FDA has granted emergency approval to Eli Lilly’s antibody treatment for COVID-19. The news comes as biopharmaceutical companies Pfizer and Moderna have announced that preliminary data from late stage clinical trials show their respective vaccines are at or nearly 95 percent effective. GBH Morning Edition host Joe Mathieu spoke with Northeastern University pharmaceutical sciences and chemical engineering professor Dr. Mansoor Amiji about what the latest developments mean for the world’s fight against the coronavirus. The transcript below has been edited for clarity.

Joe Mathieu: Is Eli Lilly’s treatment similar to the cocktail that President Trump was given? How effective is it?

Dr. Mansoor Amiji: No, it’s slightly different than what President Trump was given. He was given an antibody cocktail made by a company called Regeneron. The Lilly drug is a one, or a monoclonal, antibody. So it’s just a single antibody that recognizes the spike segment of the virus and ultimately neutralizes the virus from entering the cell.

Mathieu: So how capable are we now of treating COVID? I’m already hearing about shortages.

Dr. Amiji: The shortages and concerns in terms of making sure that distribution is going to be effective certainly raises some alarms. The production cycles are obviously moving very fast [and] the number of infections continues to increase both in the U.S. and around the world. Right now, [the] FDA is allowing emergency authorization use of this antibody from Eli Lilly, so it’s very specifically designated to a certain segment of the population, not certainly mandated for everyone.

Mathieu: So this is for high risk patients. When would the general public be able to get this type of treatment?

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Dr. Amiji: So this is specifically designated for individuals who are not in hospitals, who are infected [and] symptomatic, but clearly not admitted yet to the hospital [and] do not require a ventilator or other emergency procedures. It is specifically designated to prevent the infection from progressing to become a severe disease in those who are at high risk. So it’s a very specific population segment that it’s designated for. For the general use, the studies are still ongoing, so we don’t have all the data yet from Eli Lilly. So clearly, there is still a need to make sure that it is safe and efficacious in a wider range of population with different demographics, and be able to then show that it has effectiveness in that broad segment of the population. Subsequently, it will be approved for use in the larger, wider market.

Mathieu: How soon after infection must it be taken, Professor?

Dr. Amiji: The study that was done and published in the New England Journal of Medicine showed that within about 10 days post-infection and then, subsequently, once the patients start to experience symptoms, this antibody can be administered. The data showed that it had reduced the length of the infection period significantly, and that’s why the FDA is approving this for emergency use authorization, this particular antibody from Eli Lilly.

Mathieu: I know the vaccine is the holy grail here — that’s certainly how we treat it. But shouldn’t we be spending more time, more money [and] putting more urgency behind treatments for COVID?

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Dr. Amiji: Certainly. I think there are obviously a lot of different companies that are also working on other treatment strategies: the antibody therapeutics, such as what we are discussing is one approach; Dexamethasone, as you may have heard, is a drug that’s a corticosteroid that is already approved in the United States and other parts of the world. That also has been used in treating COVID patients, including those who suffer from the different immune reactions that occur post infection. But the encouraging news from both Pfizer and Moderna more recently, and [from] companies like AstraZeneca and others that are actually doing clinical trials in vaccines also shows a lot of promise. So I think the excitement around vaccines is clearly meant to look at the future as a way to prevent the infection, in addition to also creating therapeutics, such as what we are discussing, that will treat the infection. So I think both have to happen side by side.

Mathieu: Are we going to get to the point, Professor, whether it’s a treatment or a vaccine, [where] people are out there shopping for the brand or the version that they prefer?

Dr. Amiji: Yes, I think at some point we will have multiple types of vaccines that would be available. We are also going to then have some understanding of which ones work best in what type of patient population. So there may be some specificity of vaccines that would be applicable for the type of person — for example, someone who’s just recently infected versus somebody who’s been infected but may be asymptomatic, and to individuals who are potentially highly symptomatic and may develop severe disease. So we may have those gradations in the patient populations that may benefit from these individualized vaccines. For example, the Moderna vaccine, one of the interesting data points there is that it was actually found to be effective even in those who were severely ill, and so that clearly shows that the vaccine efficacy can be, in some way, titered according to the patient’s own profile, what level of infection they have and how severe the disease they have.

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Mathieu: We’re living through an incredible time here, Professor, aren’t we?

Dr. Amiji: We are. This is an unfortunate time, but at the same time, I think we are seeing science — really [the] development of vaccines and therapeutics — stepping up. And the timeline to how fast this has occurred, at least in my lifetime, I haven’t seen anything like this before. Then, of course, the public health measures that we are all advocating: wearing the mask, making sure that you’re social distancing and taking all the necessary precautions that are mandated by the public health professionals.



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