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Vaccines and Variants: Omicron, FDA Approval & Looking Forward | Ask An Expert

Vaccines and Variants: Omicron, FDA Approval & Looking Forward | Ask An Expert

With SMH Infectious Disease Specialist Manuel Gordillo, MD

** NOTE: This content was published Feb. 8, 2022. Information related to the COVID-19, vaccines and treatments is continually evolving. For the most up to date info, we recommend visiting the CDC’s website and the FDA website.

With the Omicron surge driving case numbers up in Sarasota and Manatee counties, Dr. Gordillo returns to Healthe-Matters for another update on the state of the surge, the latest in vaccine research and authorizations, and what the future may hold in the ongoing fight against COVID-19.

What is “Stealth Omicron”?

Some people call it “Stealth Omicron” because it cannot be detected with one test that they use to find Omicron. But that is not its main feature. The main feature is that it's very contagious—more contagious than traditional Omicron. The good thing is that it is not more lethal, and the vaccine protects you just as well.

What does this mean for the current surge?

Over time, it will probably replace traditional Omicron. I would not be surprised if, in a month or a month and a half, it becomes the most prevalent. And instead of having a fast decrease in the Omicron surge, it's going to be a slower decrease with a longer tail. But because our vaccines are so good, we don't see as many people coming into the hospital with severe disease as we saw with previous surges.

What would you say to people who are still reluctant to get the vaccine?

I would say it’s one of the safest vaccines ever made. Three doses protect you about 99% from death, which is amazing, and 90% from hospitalization, which is also amazing. To people who are reluctant, those are the two numbers that I would give them. Worldwide, they have given 10 billion vaccines already, and it's tremendously, tremendously safe.

Questions about booster eligibility, timing and which booster to get?

View the official CDC guidelines here.

View the official FDA guidelines here.

Are boosters necessary? Are two shots not enough?

A complete series of the Pfizer or Moderna vaccines is now three doses, including what traditionally has been called a booster or a third dose. If you got two doses, it’s incomplete, and Omicron has shown that. There's very little protection from infection and mild disease from getting two shots of one of the mRNA vaccines. Two doses still provide incredibly effective protection against severe disease and death. But you really need the third shot to get more significant protection.

Update: On March 29, 2022, the U.S. Food and Drug Administration authorized and the Centers for Disease Control recommended a second booster dose of the Pfizer-Biontech or Moderna COVID-19 vaccines for older and immunocompromised individuals.

Click here to read the FDA release. Click here to read the CDC release.

What about a fourth shot?

We still lack data. The Israelis published their initial experience with fourth doses. There seemed to be a decrease about threefold compared to three doses. This still needs to be published widely and needs to be peer-reviewed.

What about natural immunity? People who already had COVID and don’t want the vaccine?

I would recommend getting the vaccine. Getting immunity by getting infected is a crapshoot.

What does a vaccine for the youngest population (under 5) mean?

Even though these kids tend not to get severe disease, we still don't know whether they’re going to have long COVID or are going to be transmitting it to somebody else who is older, who is immunocompromised, who can develop more severe disease. For the kids themselves, and for society in general, there are distinct benefits. This is the only age group that has not had a vaccine approved, and they've been waiting for so long. Parents and grandparents are waiting for this to get some sense of normalcy in their lives.

Update: On February 11, 2022, the U.S. Food and Drug Administration announced that consideration of Pfizer's 2-dose COVID-19 vaccine for infants and children between six months and five years of age will be delayed until at least April, while it waits on more data evaluating the safety and effectiveness of a third dose. Click here to read the FDA release. 

Moderna got full approval for their vaccine. Will this give people more confidence to get this vaccine?

You would think that would be the case, but remember that the Pfizer vaccine was fully approved several months ago. For the 15-20% of folks who don't want to get vaccinated, I doubt that's going to make any impact. What will be allowed is more liberty for doctors to prescribe the vaccine when patients are outside the rigid cutoffs. For example, the emergency use authorization says you cannot get a vaccine before five months from the second one, but, if it's approved, a doctor can override that by saying, "You don't need to wait five months. There's a bad surge coming. Let's vaccinate you three and a half months after the last one." It gives the physicians and the prescribers more liberty to prescribe.

For people who have gotten sick with COVID before getting their booster, how long should they wait and recover before getting their booster?

The majority of the scientists will tell you to get the vaccine somewhere between two to three months after you recover from the disease, because that's when your immune system has recovered, and you get the new challenge from the vaccine. Some other scientists say if you do it earlier, like two weeks after, you may not get that full boost, but you get an extra advantage, which is it might attenuate long COVID symptoms. It appears that getting an early vaccine decreases the symptoms from long COVID or persistent COVID symptoms by about 20% to 30%.

Are we expecting more variants?

I think the majority of people who study this, virologists and evolutionary virologists, predict that there will be more variants in the future, just like what happens with influenza and other respiratory viruses, including the ones in the coronavirus family. Whether it will become more contagious or more severe, we don't know and we cannot predict.

Going forward, what do you think we really need in order to help fight whatever's coming next?

Testing. As we saw during this surge, the testing production can only grow in a linear way. The virus grows exponentially. At some point, the demand for tests will exceed the supply of tests. For the future, the government needs to buy and stockpile tests for distribution. Companies are not going to.

Why is access to testing so important?

Not only for diagnosis, but because we are also going to need tests for the therapeutics. For example, the Pfizer anti-viral drug, Paxlovid, is excellent. It decreases your hospitalization by 80%, but only if you take it within five days of your onset of symptoms. If it takes you more than five days to get the test, it's too late.

What’s next for battling COVID?

Going forward, there are going to be second-generation vaccines—vaccines protecting against all variants currently available or to come in the future, so-called pan-coronavirus vaccines. Many groups throughout the world are studying those type of vaccines. The other important vaccine in development will be intranasal vaccine to prevent you from getting infected to begin with, because the virus enters through the nose and the mouth. So you get your primary series and then your boosters would be with intranasal vaccines, if we can develop some that are effective. I think the future looks bright.

This interview has been condensed and edited for length and clarity. To watch the full interview with Dr. Gordillo, click here.

More Resources

Dr. Gordillo and SMH Critical Care Pulmonologist Joseph Seaman, MD, on COVID Treatments and Testing
COVID-19 Treatment & Recovery at Home, with SMH Critical Care Pulmonologist Joseph Seaman

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Posted: Feb 8, 2022,
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