REGIONAL- June is turning into a watershed month for COVID vaccine producers as two already approved producers are on the verge of approval for use on the youngest Americans and another seeks approval for a fourth vaccine choice for adults.
But all three share a common concern: How much demand is there for what they have to sell in a country that wants to put the pandemic largely in the rear-view mirror?
Novavax, the latest entrant into the adult-approved vaccine world, has been available internationally since last November and is currently approved for use in 41 countries including the United Kingdom, Germany, Australia, and India. The U.S. could be the 42nd after a U.S. Food and Drug Administration (FDA) advisory panel recommended its approval on June 7.
Unlike Pfizer, Moderna, and Johnson & Johnsons vaccines, however, the FDA hasn’t immediately acted on the recommendation for the Centers for Disease Control to issue the necessary approval and guidance to begin using Novavax. The FDA has said it is considering additional information from Novavax provided after the June 7 meeting had already been scheduled.
But vaccine industry consultant Manon Cox suggested in a widely cited quote from Kaiser Health News that perhaps there’s no reason to rush.
“They are applying for an emergency authorization,” Cox said. “What’s the emergency?”
Indeed, in Minnesota and elsewhere, demand for COVID vaccinations has dropped significantly. Weekly vaccinations in Minnesota had tapered off to under 18,000 in mid-March from an Omicron -wave high of 133,000 weekly doses in January.
Some unvaccinated people in Minnesota have been changing their minds – 33,000 first doses of COVID vaccines were administered in the past three months.
Specifically, for Novavax, about 13 million doses of the vaccine were distributed in European Union countries by mid-April, but less than 200,000 of those doses were actually administered. The problem with vaccine availability in 2022 has been one of inequitable distribution, with poorer countries suffering disproportionately as a result. Still, even in those countries, the push for vaccinations has been losing steam as the severity of the pandemic has declined.
Novavax, which has demonstrated its vaccine is 90-percent effective in clinical trials, is banking on picking up a large swath of unvaccinated Americans who have previously avoided vaccination because they were skeptical of the mRNA process used to develop them. Novavax uses a more traditional protein-based approach in which a non-disease-causing portion of the coronavirus spike protein is injected to stimulate the production of antibodies.
Children’s vaccines
On Tuesday, the FDA advisory committee recommended emergency use authorization of the Moderna vaccine for children ages six to 17. The action comes about eight months after the Pfizer vaccine was approved for children five and older. Children 12 to 17 will receive adult-sized shots of Moderna, while younger children will receive smaller doses.
A more significant development was likely to occur on Wednesday when the advisory committee was scheduled to consider use of both Pfizer and Moderna for children as young as six months old. The panel gave its thumbs up and a subsequent CDC review on Friday and Saturday did likewise, shots for these youngsters could begin as soon as Tuesday, June 21.
However, the companies could find parental skepticism a tough nut to crack. An April survey by the Kaiser Family Foundation, the latest of more than a year of such monthly surveys, showed that less than one in five parents would get their children vaccinated right away. By contrast, almost a third of all parents remain steadfastly opposed to getting their children vaccinated, and two-thirds say they don’t have enough information to decide. Somewhat mirroring that, four out of ten parents said they would take a “wait and see” approach before making a decision.
New variants
Omicron variants BA.4 and BA.5 are no longer an anomaly in Minnesota, they’re a significantly increasing share of the caseload in Minnesota, accounting for a about one-fourth of all new cases when combined. BA.2.12.1 still accounts for the majority of cases, which continued their overall downward trend this past week. Monday’s reported statewide total of about 1,500 new cases was about a thousand fewer than the week prior.
BA.4 and BA.5 appear to be the most highly contagious variants to date, with the ability to more effectively elude immunity induced by vaccination or prior COVID illness. However, it is becoming more evident that the symptoms caused by the pair are no more severe than those of BA.2.12.1, a fact reflected in the state’s relatively low hospitalization and death rates.
But with the science surrounding these and other variants new and evolving, noted University of Minnesota epidemiology expert Michael Osterholm said in a podcast last week the future is hard to predict.
“It is very difficult to predict things about the future when your crystal ball that you use every day has five inches of caked mud on it,” he said. “As I told someone in an interview this past week, I’m starting to feel like a COVID meteorologist. I can give you an idea about the forecast for the next two or three days. Beyond that, I really can’t tell you what’s going to happen, and I feel very much the same way with this situation here.”
However, he’s certain that the pandemic will be with us for the foreseeable future.
“I’m convinced, particularly with what we’ve seen in Europe, that we will see BA.4 and BA.5 becoming the dominant sub-variants within the next several weeks,” he said. “I can tell you that this pandemic is not over and trying to declare it as such would be a huge mistake. It’s deja vu all over again for me. Remember a year ago right now, some of you on this podcast know I got hammered pretty hard when I said in mid-June that I thought that some of the darkest days of the pandemic could still be ahead of us because of the unknown impact of the variants.”
And indeed, after most of the country celebrated the demise of the pandemic by lifting COVID restrictions last summer, what followed in the winter and fall were two of the largest waves of the entire pandemic.
Test-to-treat
The three major state-operated testing centers, including the Duluth Entertainment and Convention Center, changed over this past week to what are being called “test-to-treat sites.”
Those who go to the DECC and test positive for COVID now have the option to be evaluated on site and given a prescription for the antiviral medication Paxlovid if it is deemed appropriate. Clinical trials found that a five-day course of Paxlovid cut a patient’s risk of hospitalization and death by 89 percent. However, the antiviral has generally been underutilized.
Only patients deemed “high risk” will receive a Paxlovid prescription, which can be filled at a pharmacy of the patient’s choice. Both the test and medication, if necessary, are administered at no cost to the patient.