Moderna’s Spikevax Scores Full FDA Approval while Omicron BA.2 Picture Emerges

News that a subvariant of the Omicron variant has appeared in the U.S. and parts of Europe doesn’t seem like good news. The latest data suggest it’s 1.5 times more transmissible than the original Omicron variant, but not necessarily deadlier.

News that a subvariant of the Omicron variant has appeared in the U.S. and parts of Europe doesn’t seem like good news. The latest data suggest it’s 1.5 times more transmissible than the original Omicron variant, but not necessarily deadlier. Moderna‘s COVID-19 vaccine finally receives full U.S. Food and Drug Administration approval, and Novavax finally submits its emergency use authorization (EUA) request to the U.S regulator.

FDA Fully Approves Moderna’s COVID-19 Vaccine

Becoming only the second mRNA-based vaccine or therapy to ever be fully approved, the FDA signed off on Moderna’s COVID-19 vaccine for people over the age of 18. The brand name of the vaccine is Spikevax. People have been receiving it for over a year under EUA.

“The public can be assured that Spikevax meets the FDA’s high standards for safety, effectiveness and manufacturing quality required of any vaccine approved for use in the United States,” stated Acting FDA Commissioner Janet Woodcock.

Novavax Submits EUA Request to FDA for its COVID-19 Vaccine

In what seems to be a very long time coming, Maryland-based Novavax submitted a request to the FDA for EUA for NVX-COV2373, its protein-based COVID-19 vaccine candidate against COVID-19. The company ran two pivotal Phase III trials in which the vaccine demonstrated efficacy and a reassuring safety profile. The vaccine has been authorized with its manufacturing partner the Serum Institute of India in several other countries, including Europe. It is also listed for emergency use by the World Health Organization and is available in more than 170 countries.

Originally Novavax planned to request EUA by May 2021, but put off the request over several development and manufacturing roadblocks.

Omicron Subvariant BA.2 1.5 Times More Contagious Than Omicron

Although not widespread in the U.S.—yet—the subvariant of the Omicron variant known as BA.2 is reportedly 1.5 times more transmissible than Omicron. As of Friday, January 28, 127 cases had been identified across the country. It doesn’t seem to be any more lethal than Omicron, which is generally as less severe than earlier variants. Nor does BA.2 seem to evade vaccines and immunity more than Omicron.

However, it is of concern because, in Denmark, as the Omicron surge was waning, BA.2 surged again. There is some evidence BA.2 is also beginning to spread in England and Germany.

Preliminary evaluations suggest a booster dose of vaccines was 70% effective at preventing symptomatic COVID-19 from BA.2 two weeks after the shot compared to 63% for the original Omicron strain.

“The next variant of concern will be more fit, and what we mean by that is it will be more transmissible because it will have to overtake what is currently circulating,” said Dr. Maria Van Kerkhove, the World Health Organization’s technical lead. “The big question is whether or not future variants will be more or less severe.”

What isn’t known is how well exposure to the Omicron variant—and original variants—will protect against BA.2 and any other emerging variants. Generally, there is an assumption that the broader the exposure to SARS-CoV-2 via infections and immunity provided by vaccines will create high levels of population immunity. If so, there may continue to be infections but much lower rates of hospitalizations and deaths. For example, in Denmark, although the infection rate is high for BA.2, there are not many reported hospitalizations.

COVID-19 May Have Seasonal Spikes

When COVID-19 first emerged two years ago, one of the questions was whether or not it would be seasonal, more common in cold winter months and less common in warm summer months. It didn’t exactly seem like it was. However, new research published in the American Journal of Tropical Medicine and Hygiene suggests it is. The study suggests that colder areas, such as the U.S. northeast, may have more cases during the winter, while warmer areas, such as the southern U.S., may see more transmissions in the summer. Temperate zones might have two seasonal peaks.

“We think COVID may be becoming endemic, meaning that it will stay within the human population, but we will see spikes based on where we are in a particular geographic point,” said Dr. Antarpreet Jutla, a hydrologist at the University of Florida and senior author of the study. “The severity of peaks will be defined by how colder the temperature is and how warmer the temperature is.”

Essentially, in analyzing 19 hot spots worldwide, the researchers found cases spiked when air temperatures dropped below 62 degrees F or above 75 degrees F. It also appears to last longer in drier environments compared to humid ones.

COVID-19 Mutations Develop in HIV and Immunosuppressed Patients

A study from South Africa found that SARS-CoV-2 mutates quickly when harbored in immunosuppressed people, such as those with HIV not taking medications. This, in turn, can lead to new variants. The researchers describe a case of a 22-year-old South African woman with inadequately treated HIV who harbored COVID-19 for nine months. In that period, the virus developed at least 21 mutations. Once given anti-retroviral drugs for HIV and her immune system recovered, she beat back COVID-19 in six to nine weeks.

“This case, like others before, describes a potential pathway for the emergence of novel variants,” the researchers wrote, although they emphasized that this was hypothetical. “Our experience reinforces previous reports that effective antiretroviral treatment is the key to controlling such events.”

Is Long COVID Driving the Great Resignation?

Much has been made of the so-called “Great Resignation,” with companies unable to find workers and people leaving their jobs in droves. A new research from the Brookings Institutes suggests that one factor to this wave of resignations might be Long COVID. The study found that the equivalent of 1.6 million people is out of the workforce in the U.S. because of Long COVID. Long COVID has up to 50 different symptoms, including fatigue, “brain fog,” headaches, memory loss and heart palpitations.

Katie Bach, a nonresident senior fellow at the Brookings Institution, was caught off guard by her research, saying she was “floored” when she began calculating the numbers of people in the workforce who aren’t in the job market because of Long COVID.

“It was so much bigger than I thought it would be,” Bach told CBS MoneyWatch. “Then it was like, ‘Why is no one talking about this?’”

The labor shortage appears to be approximately 2.2 million people compared to its size pre-pandemic.

Some Experts Have Thrown Up Their Hands at Predicting COVID-19 Behavior

Most experts agree that COVID-19 has been peculiar and unpredictable. Yet they continued to make predictions—often inaccurately—for the last two years. Although many researchers are continuing to churn out predictive models and projections, some are starting to admit their predictions have often been wrong.

“There are various scenarios and they vary between rosy and gloomy,” said Dr. John Moore, a virologist and professor at Weill Cornell Medicine in New York. He emphasized that anyone saying they knew for certain what would happen next was full of “it.”

Dr. Joshua Schiffer, a virologist and mathematical modeler at the Fred Hutchinson Cancer Research Center in Seattle, less colorfully said, “I have just been so humbled and surprised by these variants of concern and the number of unanswered questions we have about them, where they came from, why they arise.”

Dr. Schiffer added, “It’s difficult to project whether one of the viruses will permanently displace another or whether they’ll coexist in the population or whether a new variant will displace both of them. Unfortunately, I don’t think it’s possible to really know yet.”

MORE ON THIS TOPIC