COVID-19: Trends that will define 2022

It’s 2022. What can we expect?

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We sat down with Bill Dreitlein, Pharm.D., BCPS, Senior Director, OptumRx Pipeline and Drug Surveillance for an insider’s look at what’s coming, what’s important on the COVID-19 scene.

1. The last part of 2021 saw a flurry of activity around the COVID-19 vaccine. Can you give us a sense of what to expect in the coming year regarding vaccines?

Clearly things are moving very fast in this space. When I look out at 2022, I think we will see four broad developments:

First, we will see the existing Emergency Use Authorizations (EUAs) begin to convert to full FDA authorizations. Actually, and I realize it may be a little confusing, this process is already underway.

The Pfizer-BioNTech COVID-19 vaccine received FDA authorization last summer for individuals ages 16 years and older. Once vaccines are approved by the FDA, companies can market the vaccines under brand names, so this vaccine is now called Comirnaty^® – but just for this age group. For people 5 to 15 years old, it is still referred to as the “Pfizer-BioNTech COVID-19 vaccine.”

Second, I expect to see vaccination recommendations being extended to children under age five. Right now, the Pfizer-BioNTech vaccine is the only one recommended for people aged 5 to 12 years and older. The Johnson & Johnson and Moderna vaccines are still EUA authorized only for adults aged 18 and older.

Third, we can probably expect to see booster shots recommended for children, just as for adults. We know that immunity begins to wane in adults who have received their COVID-19 vaccinations after about six months. If children follow the same pattern, they will also need a booster shot to maintain their protection. But we will have to accrue enough post-vaccination data to make an informed decision.

The fourth development I see for 2022 regarding vaccines is the possibility of additional booster shots in adults. These would be in addition to the ones currently authorized. This is a bit speculative since it depends on a couple variables. One is how long does a booster shot remain effective? Will it be the same as the initial immunization? Or will they last longer, or shorter? We don’t know. The other variable is how long will the pandemic last? This will turn on the rate of transmission in the general population, based on vaccination rates and new variants.

That last idea about variants is certainly top-of-mind right now, with the recent news on the new variant (initially found in South Africa) called omicron. Early indications are that omicron seems to be much more transmissible than previous variants. The good news is that disease severity may be less severe, and that the vaccines we have now appear to still be effective.

But let’s say it turns out the vaccines really aren’t as effective against a new variant as they need to be. In that case the manufacturers have been actively preparing for just this kind of situation. They have been working on new versions of their existing vaccines, and in general getting ready to quickly produce more effective versions if that becomes necessary. It’s helpful that the mRNA technology is especially flexible in this regard. For example, Pfizer-BioNTech predicts they will be able to launch an updated mRNA vaccine within 100 days.

2. What have we learned about the risk/reward factors for different vaccines among various population groups?

Worldwide nearly nine billion doses of the vaccine have already been administered, including second shots and boosters. Side effects are extremely rare. Studies have shown that all of the vaccines used in the U.S. protect very well. This includes the earlier Delta variant but also, so far, they seem to be effective against omicron. Unvaccinated people have a 5 times greater risk of infection and more than 10 times greater risk of hospitalization or death compared with vaccinated people.

That said, there is some evidence that certain groups may be at slightly increased risk of side effects from some vaccines. For example, some males under age 30 have experienced myocarditis, which is an inflammation of the heart muscle, after receiving the Pfizer-BioNTech or Moderna coronavirus vaccines.

The vast majority of cases are mild and resolve quickly. Again, these reports are very rare: approximately 1 of 26,000 men. In any case, health authorities stress that the known and potential benefits of COVID-19 vaccination far outweigh their known or potential risks. In fact, myocarditis is more likely to occur as a result of COVID-19 infection than as a side effect of the vaccines. The CDC estimates that this happens in approximately 1 in 667 infections.

3. Still on the topic of vaccines, right now the Federal government is paying for shots. What happens when that stops?

This is a pretty interesting area. As you say, right now governments have been the only purchasers of the COVID-19 vaccines, so the prices have been set by government contracts. That’s just for the vaccine itself. Insurers and plan sponsors are paying for the cost of administering those shots, without cost to members.

Eventually the government won’t be paying for the vaccines anymore, at which point insurers and plan sponsors will have to start. But in order for insurers and plan sponsors to cover any drug, it has to be approved for use by the FDA. So that’s step one.

Actually, there are already coverage rules that make it mandatory for most plans to include recommended vaccinations as part of their preventive care, at no cost to the member. Annual flu shots are an example here. We might see COVID-19 vaccination added to that recommended list if the pandemic continues.

Let’s go back to prices. In the U.S. the Pfizer-BioNTech vaccine costs the government just under $20 per dose, while the Moderna vaccine costs about $15 per dose. For comparison, the usual price for a dose of flu vaccine costs around $20.

Unfortunately, that per-dose price might go higher once the pandemic is over. The CEO of Pfizer has said that the current price reflects what he calls “pandemic pricing,” meaning they consider it to be underpriced. Both Pfizer and Moderna have talked about raising prices significantly once the pandemic phase is past.

We don’t know how this will play out, but naturally this is an area everyone is going to be watching closely.

4. Some new oral antiviral treatments are in the news. Can you comment on where things stand with respect to treatments for patients who have contracted COVID-19?

For sure these oral treatments are big news. There are two main players right now: molnupiravir from Merck and Ridgeback Biotherapeutics, and Paxlovid™ from Pfizer. Both received emergency use authorization from the FDA in December to treat mild-to-moderate COVID-19 in adults 18 and older.

The drugs work somewhat differently, but basically both prevent the COVID-19 virus from reproducing in the body. Both drugs need to be given within 3-5 days after infection to be effective.

Early trials for both drugs were very encouraging. In people with mild or moderate forms of COVID-19, molnupiravir reduced the risk of hospitalization by 50%, while Paxlovid reduced hospitalizations by 89%. However, after the initial announcement, Merck issued a correction. Their new analysis based on a larger group of individuals indicated that molnupiravir only reduced the risk of hospitalization by 30%, not 50%. Still, the FDA authorized both drugs for use.

It’s also notable that molnupiravir and Paxlovid are small molecules, which means they should be relatively easy to manufacture, and, hopefully more affordable. In the press we’ve seen estimates of $700 for a 5-day course of molnupiravir, with Paxlovid priced even lower, at $530 per course. If true, this would help increase access. Even better, they can be taken at home, which would help reduce the pressure on the health care system.

We can imagine a number of ways these new drugs could be used, for example, as an alternative for those who for some reason cannot take the vaccine. Or, they could play a role in helping to address new variants, like omicron.

Distribution for these drugs should parallel what we saw with the early phase of the vaccines. In other words, the government will take the lead role in prioritizing who will get them based on demographic risk and regional hot spots. Health care providers will be able to order doses within caps set for each state.

We can also expect quantity limits at first, in order to discourage hoarding.

Pharmacies could easily play a role in distribution. Also, since initiating treatment early is so important, we may also see pharmacies helping with testing and diagnosis.

Aside from the two new orals, there are several products that have received emergency use authorizations to treat mild to moderate COVID-19. These include the antiviral agent remdesivir, and three monoclonal antibodies.

These have been shown to shorten hospital stays for some patients. But they are expensive, and especially for the monoclonals, hard to make, which limits the supply. Also, they must be given intravenously in a hospital.

5. Following up on treatments, do you foresee these as significant cost drivers?

As far as the cost of the drugs themselves, the situation is similar to vaccines: the government is paying these costs, at least for now. Again, plan sponsors are paying the cost of dispensing and administration.  

Also like the vaccines, we’ll have to see what happens to prices once the government ends its subsidy. As we noted above, these are small molecule drugs, not complex biologics, and the intended treatment population is very large. So hopefully the prices will stay reasonable.

But costs will also depend on how many people might need to be treated. In some cases, previously vaccinated people might also need antivirals, for example if a new variant evolves that escapes the immunity provided by existing vaccines. But more likely demand will be driven by the overall vaccination rate: maintaining immune protection through boosters, responding to new variants, and the ongoing need to get everyone vaccinated.

Over the short to mid-term, the actual costs to plan sponsors for these new treatments may well be limited by supply. At least for now, the ability of the drug makers to produce these drugs is limited. The government has contracted with Merck for enough molnupiravir to treat just under two million Americans. The government has also signed a deal to secure up to 20 million courses of Paxlovid for $5.3 billion.

Looking into next year, Merck says they will be able to produce around 20 million courses of treatment in 2022, while Pfizer's estimates is will produce 80-120 million courses of Paxlovid in 2022 – but in each case that’s for the whole world.