1 of 5 | Increased availability of vaccines and treatments globally could help end the pandemic in 2022, experts say. File Photo by Abhishek/UPI | License Photo
Dec. 28 (UPI) -- The recent approval of two new treatments for COVID-19 means that 2021 ends on a bit of a high note, at least in terms of the pandemic, even as cases rise in many parts of the country.
On Dec. 23, the Food and Drug Administration granted an emergency use authorization for Merck's antiviral pill, molnupiravir, "for the treatment of mild-to-moderate" COVID-19 in adults.
Molnupiravir, which is sold under the brand Lagevrio, joins Pfizer's combination pill, sold under the brand name Paxlovid, as treatments those with the virus can take at home before they get sick enough to need hospital care, officials said.
The FDA granted similar emergency approval to Paxlovid, which combines the antiviral drugs nirmatrelvir and ritonavir, only 24 hours earlier.
Both medications were found to lower a person's risk for hospitalization and death due to COVID-19 in clinical trials.
The new drugs should "take down Omicron in its tracks," Eric Topol, founder and director of the Scripps Research Translational Institute in La Jolla, Calif., told UPI in an email.
He was referring to the new, more transmissible, variant of COVID-19 that emerged in late November.
But will they, along with the three vaccines against the virus that became available earlier this year, be enough to bring about an end to the pandemic in 2022?
The past year began with a lot of optimism, thanks to the availability of multiple vaccines that, safely, offered protection against the virus, and it ended with these new treatments in the pipeline.
However, the middle of the year saw a relaxation in masking and social distancing restrictions that marked much of 2020 in many parts of the country, and with it came surges of new infections, first with the Delta variant and then with Omicron.
The latter is now responsible for most of the new COVID-19 cases nationally, and it may not respond as well to currently available vaccines and treatments, according to experts.
Still, there is reason for cautious optimism as the calendar flips to 2022. Once the ongoing winter surge in cases ends, the vaccines and treatments should allow the country to at least cope with the virus, if not bring an end to the pandemic.
"You can always look at glasses half-full or half-empty, but we were in a far worse situation a year ago than we are today because the vaccines are quite effective," Dr. Reynold A. Panettieri, who has expertise in diseases of the airway and immunology, told UPI in a phone interview.
"We all are experiencing COVID-19 fatigue, and we just want it to be gone but, frankly, we're powerless in determining its extinction, and it will likely never go away," said Panettieri, a professor of medicine at Rutgers University's Robert Wood Johnson Medical School.
"I think we are closer to an end of the pandemic, but that does not mean that this disease will disappear," Dr. Tony Moody, an associate professor of pediatric infectious diseases and immunology at Duke University Medical Center, told UPI by email.
"It will shift from being pandemic to endemic, something that sits in the background of our lives, like influenza or the common cold, which means we will probably have periods or years where it is worse or better, but it will stop dominating the news cycles," he said.
Here's what's known now, as the world enters year three of the COVID-19 pandemic, about what the virus is and how it affects people and the mitigation methods that could be effective against spread, with or without widespread vaccination.
Where we started
Once the Food and Drug Administration approved COVID-19 vaccines in late 2020, the priority became ensuring the nation's most vulnerable to severe illness from the virus were inoculated.
This included the elderly and those with chronic health conditions that placed them at increased risk, such as diabetes, heart disease and the lung disorders asthma and chronic obstructive pulmonary disease, according to the Centers for Disease Control and Prevention.
Although the initial rollout of the vaccines last spring was successful, the numbers of those seeking to get the shots began to slow as the summer approached.
Now, nearly one year after they first became available, roughly 60% of people eligible for the vaccines in the United States -- essentially everyone age 5 years and older -- are fully vaccinated, the CDC reports.
This means they have received both doses of the Moderna and Pfizer-BioNTech vaccines or the one-shot Johnson & Johnson jab, based on agency guidelines.
That's well below the level needed for "herd immunity," or widespread protection against infection within the general population, experts say.
In addition, the emergence of the more lethal Delta variant hit the unvaccinated particularly hard, leading to a surge in hospitalization and deaths that has continued well into the fall and winter in many parts of the country.
That at least partially explains why more than 450,000 people in the United States country died of COVID-19 this year, even with vaccines available, compared to about 350,000 in 2020, based on data from Johns Hopkins University.
The deaths also may be linked to the decision by many state and local governments nationally to relax masking and social distancing restrictions after vaccine availability just as the new variant began to spread, infectious disease epidemiologist Dr. Chris Beyrer said.
"There is a lot of variation in how these non-vaccine interventions were handled, but there is no question that they became politicized [and] were applied unevenly," said Beyrer, a professor of public health and human rights at Johns Hopkins Bloomberg School of Public Health in Baltimore.
"Now, they are becoming harder to impose as resistance to them is rising in many countries as people tire of restrictions," he said.
To boost vaccination rates, President Joe Biden in July issued mandates that required all federal employees, as well as those who work for companies with 100 or more employees, to be fully inoculated.
Many state and local governments, including those in New York and California, followed suit.
However, the mandates are unpopular with some and have been challenged in the courts, though they did help push vaccination rates higher.
Delta variant becomes dominant
All viruses genetically mutate as they circulate so they can survive, and the one that causes COVID-19 is no exception, as each new case provides a "host" -- or platform -- for the virus to mutate, Rutgers' Panettieri said.
The Delta strain has seven genetic mutations in the COVID-19 spike protein, which is targeted by the vaccines from Johnson & Johnson, Moderna and Pfizer-BioNTech.
The variant, which first emerged in India in early 2021, had been the predominant one in the United States since the spring.
Between early May and late July, the Delta variant grew from less than 2% of new cases to more than 80% nationally, according to the CDC.
The mutations found in the variant are sufficient to make it less susceptible to the vaccines, research published earlier in December found.
That study confirmed findings from the CDC, released in August, which indicated that the currently available vaccines were up to 80% effective at preventing new infections from the Delta variant, down from more than 90% with earlier strains.
This is because genetic mutations in new variants effectively change the shape of the COVID-19 spike protein, which limits the ability of antibodies, or proteins created by the immune system to fight off viruses, from recognizing them.
The newly emerging Omicron variant has 32 genetic mutations to the spike protein, experts say, which may further limit the effectiveness of the vaccine.
Because of these mutations, the United States will likely see a winter surge in COVID-19 cases fueled by both variants that will stretch into 2022, said Scripps' Topol.
"Delta and now Omicron have definitely prolonged the pandemic," said Topol, who is also a professor of molecular medicine at Scripps.
"The virus has mutated quite substantially in its second year, when it was fairly stable for the first and this has made it far more contagious," and possibly resistant to vaccine, he said.
However, the data suggests that the currently available vaccines still prevent serious illness from COVID-19, even with the new variants, according to Duke's Moody.
"Vaccines clearly have a benefit because they drastically reduce hospitalization, severe disease and death," Moody said.
"Although there is a narrative about how the variants resist the vaccines, it's important to understand that the measurements only look at one narrow aspect of the immune response and they likely underestimate the efficacy of vaccines," he said.
Plus, any declines in immunity from the vaccines can be overcome through booster doses, he added.
The past year has also seen advancements made in effective treatments against COVID-19 once people get infected, Moody said.
Some of the most promising treatments for the virus are hardly "new." These include convalescent plasma, or blood transfused from people who have recovered from the virus to those who are newly infected.
Plasma, which has been used to treat infections for more than 100 years, contains antibodies -- proteins produced by the immune system to fight off viruses -- and can boost the body's immune response, research suggests.
Monoclonal antibodies, or those created in a lab that are modeled on the human-made proteins, have also shown promises, though the currently available formulas do not work as well against the newer variants, as they were based older ones, according to Moody.
Another older treatment that seems to work well, at least in hospitalized patients with severe COVID-19, is corticosteroids, particularly dexamethasone, though they are reserved for those with serious, life-threatening symptoms.
Repurposed drugs that do not work well for COVID-19 include the anti-malarial hydroxychloroquine and ivermectin, which is used to treat several viruses in animals and may be effective at managing the symptoms of river blindness in humans.
In addition, remdesivir, originally developed to treat Ebola, has produced mixed results in studies when used in hospitalized COVID-19 patients.
Indeed, of any of the COVID-19 treatments that have emerged as 2021 draws to a close, molnupiravir and Paxlovid show the most promise, Scripps' Topol said, and the latter has been cleared for use in those age 12 years and older.
In clinical trials, Paxlovid reduced infected patients' risk for hospitalization and death by up to 90%, while molnupiravir lowered them by 30%.
However, questions remain as to their availability and cost, according to Moody.
The Biden administration has ordered enough of Pfizer's Paxlovid to treat 10 million people, at a cost of about $530 per course of treatment, but the supply will be limited at first, officials and the company acknowledged.
Pfizer has promised to provide less than 300,000 courses of the new drug by the end of January, while Merck has committed to delivering 3 million of its product, which costs $700 per course, within the same time frame.
There have been indications that President Biden may use the National Defense Act to boost production, but no announcement has been made as yet.
Currently, COVID-19 vaccines and treatments are free in the United States, though how long that will remain the case is unclear, as is whether private insurance companies will step in to cover them, Rutgers' Panettieri said.
Boosters and the future
Still, the primary objective is to keep people from getting sick with COVID-19, so the emphasis remains on vaccines.
Booster doses for all three vaccines in the United States have been recommended -- and available -- since September.
Recipients of the two-dose vaccines from Moderna and Pfizer-BioNTech have been advised to get booster shots six months or more after their second dose, according to the CDC.
Johnson & Johnson vaccine recipients get a booster dose in as little as two months after their first shot, the agency says.
These boosters will likely be needed for the foreseeable future, as COVID-19 is likely going to remain in circulation like the common cold, Beyrer, of Johns Hopkins, said.
However, it is possible vaccines will evolve into annual boosters similar to the flu shot as manufacturers revise their formulations to combat new variants, according to Panettieri.
He believes vaccine modifications, and widespread uptake of the booster shots, eventually could create herd immunity.
"I think refinement of our boosters to meet the challenge of Omicron, and maybe the next variant, will make them more effective," Panettieri said. "We're going to get over this, though it may not be in the time frame we want."
How quickly the country, and the world, emerges from the pandemic most likely will depend, at least in part, on widespread access to vaccines and virus treatments, Panettieri said.
Access to these important advances remains limited in many parts of the world, particularly in Africa and parts of Asia, he added.
In addition to modified versions of the current vaccines, researchers are working on a "pan-coronavirus" shot that will, ideally, work against all variants of the virus that causes COVID-19, Scripps' Topol said.
This new vaccine is expected to begin clinical trials early in 2022, he said.
However, even with new, better shots, Topol wants to see more regions in the United States develop what he calls a "Vaccine Plus strategy" that includes vaccination, booster doses and "additional mitigation measures that we know work."
This includes masks and some limits on large, indoor gatherings, he said.
"That approach has worked quite well in many countries, such as Japan," Topol said.
"When Norway and Denmark stopped all mitigation many weeks ago, Delta surged, and now they are dealing with Omicron on top of that," he said.
Now almost two years into the pandemic, scientists and public health experts have a much better idea of how COVID-19 spreads, and that is through airborne transmission of respiratory droplets from the noses and mouths of those infected, said Duke's Moody.
Understanding how the virus spreads has also enabled those on the frontlines of the pandemic to better predict when, and potentially where, new variants will emerge, he said.
"We have been able to watch this virus evolve in real time, so we have been able to tie changes in the virus to epidemiology, meaning we can track new viruses emerging and more accurately predict which strains would become dominant or replace earlier strains," Moody said.
"It's just like weather forecasting and it's gotten more accurate over time," he said.
Only time will tell whether the enhanced ability to track the virus and its evolution will enable the world to finally fully emerge from the pandemic in 2022, he added.