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How easy is it to update the COVID vaccine and work on a new variant?




The ongoing battle between the COVID variants Delta and Omicron highlights how fast the virus mutates and what it means for public health. How quickly can the COVID-19 vaccine be changed to address new variants that emerge?

There were also questions about rapid testing to detect COVID-19 and why it is so difficult for people to get test kits.

To learn more about both of these subjects, we Jennifer Pancorbo, Vaccine Manufacturing Expert and Director of Industry Programs and Research at North Carolina State University’s Biomanufacturing Training and Education Center.

This post is part of A series of Q & A North Carolina State University experts are working on questions related to COVID-19.

wrap up: You know that you are familiar with the manufacture of influenza vaccines. Influenza vaccines are changed each year to take into account the influenza strains that experts believe will be prevalent next year. However, we also know that the COVID-19 vaccine is an mRNA vaccine and an adenovirus vaccine, but not the influenza vaccine. How difficult is it for a COVID-19 vaccine maker to change vaccines to account for new strains of SARS-CoV-2, such as the Omicron variant?

Jennifer Pancorbo: Differences in vaccine platform technology should not undermine the manufacturer’s ability to respond to new strains of the virus. If anything, mRNA technology provides a platform for faster responses. Unfortunately, responding to the annual changes in the predominant viral strain faces other challenges in addition to manufacturing capacity.

TA: Can you explain what those other challenges are?

Pancorbo: One is the highly established global network for influenza virus monitoring. There is no equivalent to COVID-19. For influenza, there are centers around the world that collect data on strain circulation. Experts then use the data to make informed guesses about which strains are most likely to pose a major health threat to the public. These strains are then incorporated into seasonal vaccine formulations.

In the case of COVID-19, such strict monitoring has not yet been performed. Therefore, it is difficult to predict the formulation.

In addition, we have a complex supply chain network of influenza vaccine manufacturing components that are ready months before production begins and use previous year’s forecasts to estimate demand. Without these systems in place, it seems difficult to respond quickly to new coronavirus strains.

And there is a risk. The decision on which formulation to manufacture each year for influenza is a risk calculated based on years of experience. Without experience backing, companies may be reluctant to accept the risk of producing a new COVID-19 vaccine that targets a particular strain.

TA: When do you think you will see a new COVID-19 vaccine that describes the new strain of SARS-CoV-2?

Pancorbo: It’s hard to predict. The virus is mutating very quickly and new strains appear to emerge daily. There is no monitoring yet. And the test needs to be ready to support such monitoring. This is because we are facing a testing crisis and all these systems can slow down even further. The best alternative at this time is to slow the spread of COVID-19, reduce the number of hosts for the virus, and limit its ability to mutate to new strains.

TA: Will the new vaccine effectively be a single dose booster, or will it require two doses, as it was when the Pfizer and Moderna vaccines were first vaccinated?

Pancorbo: It depends on the efficacy of the new vaccine and the risks posed by the new strain. For example, if the new strain does not cause many mortality rates, it can be less effective. However, if this is not the case, a higher immune response needs to be elicited, which may result in the need for two doses again.

TA: How will the development of the COVID-19 vaccine, which describes the new variant, affect our ability to vaccinate people around the world who have not yet been vaccinated?

Pancorbo: Regulations require the facility to clear the old product from the manufacturing floor before starting production of the new product. Therefore, in order to produce a new COVID-19 vaccine, it is necessary to stop the production of the previous vaccine. As a result, older vaccine formulations may be less available to those who have not yet been vaccinated.

TA: Also, I would like to ask some questions about the rapid test of COVID-19. First, how do they work? And how effective is it in detecting COVID-19?

Pancorbo: The quickest test is, in principle, similar to a pregnancy test. It detects the presence of the analyte in the sample, but the minimum threshold must be met for the detection to occur. Rapid testing is as reliable as any other pregnancy test. If the test is too early, there will not be enough analyte to be positive for the sample. This does not mean that the test is bad or inaccurate, it just means that there is a minimum detection limit that the test must meet for it to work.

If a rapid test gives a negative result, it can be concluded that there is not enough viral load to detect at the time of the test, either because it is negative or because the infection has not yet progressed sufficiently. increase.

Is it possible to have false negatives? Yes, but the reason is less likely than the two I have already mentioned.

TA: Why are people so struggling to get a quick test right now?

Pancorbo: Several reasons: supply chain limitations, limited workforce due to COVID infection of oneself or family, extensive inspection due to new proliferation of Omicron strains, and lack of planning by local and federal governments. Approval and development of commercial COVID-19 test.




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