With expectations that the U.S. FDA will announce a decision about booster shots for the Moderna and Johnson & Johnson vaccines this week, there is plenty of COVID-19-related news. Here’s a look.
With expectations that the U.S. Food and Drug Administration (FDA) will announce a decision about booster shots for the Moderna and Johnson & Johnson vaccines this week, there is plenty of COVID-19-related news. Here’s a look.
Why are Moderna and Pfizer-BioNTech Using Original COVID-19 Formulations?
One of the selling points of the mRNA COVID-19 vaccines produced by Moderna and Pfizer-BioNTech is that they are easily adjusted. Which begs the question, once the delta variant became the dominant strain, why didn’t they modify their vaccine formulations? Why push for boosters of the original formulation? It’s a question that even the FDA’s vaccines advisory committee has raised.
“I don’t quite understand why this is not delta because that’s what we’re facing right now,” Patrick Moore of the University of Pittsburgh, a member of the advisory committee, asked when they were evaluating the Moderna booster shots last week.
The answer seems that the FDA approved boosters of Pfizer-BioNTech’s original formulation after studies showed it worked well enough against the delta variant and there would be no delay while they reformulated.
“It’s less churn and burn on the manufacturing,” said Peter Marks, the FDA’s vaccine boss.
Nonetheless, Pfizer-BioNTech and Moderna are testing formulations targeting delta and another variant. At least one immunologist, John Wherry with the University of Pennsylvania, wonders if a reformulation would even work better against delta. Mutations in the virus’s spike protein make the delta variant more contagious, but it doesn’t make a big difference in the immune system’s ability to recognize the virus. However, an argument for an update is that although delta is the dominant strain globally, if there’s another variant that rises to the top, it will probably mutate out of delta.
J&J’s COVID-19 Vaccine Brought in $502 Million in Q3
Although the Johnson & Johnson vaccine lags behind the Moderna and Pfizer-BioNTech COVID-19 vaccines, it’s still profitable for the corporation. The company issued its third-quarter earnings report and cited $502 million in COVID-19 vaccine sales. Its sales outlook for the year is $2.5 billion. Otherwise, it reported better-than-expected profits overall, driven by its consumer health, pharmaceutical and medical devices units. The pharmaceutical business, which handles the COVID-19 vaccine, reported $12.9 billion in revenue for the quarter, a 13.8% year-over-year increase.
Interferon No Help with COVID-19 Pneumonia
A National Institute of Allergy & Infectious Diseases (NIAID) trial reported no faster recovery in hospitalized patients with COVID-19 pneumonia when treated with interferon beta-1a and Gilead Sciences’ Veklury (remdesivir) compared to Veklury alone. The ACTT-3 trial found no significant difference in mortality rates in either group, with a 5% mortality rate in the interferon group compared to 3% with Veklury alone. Some studies have suggested that interferon might improve COVID-19 outcomes, but the WHO SOLIDARITY study showed no survival benefit.
Will FDA Approve Mix-and-Match COVID-19 Vaccines?
The U.S. FDA is expected to make an announcement on Wednesday, October 20, regarding whether to authorize boosters for the Moderna and Johnson & Johnson vaccines. Insiders think the agency will also make a recommendation on whether people can get booster shots that are different from their primary doses.
The two federal officials who discussed the subject with The Washington Post noted that it was possible the FDA would say the public should, for the most part, just take boosters that are the same as their initial shots. However, in some situations, such as nursing homes that might not have access to the original vaccine or people who had adverse reactions to mRNA vaccines, taking a different shot might expedite boosters and minimize the risks of side effects.
The Science Behind Breakthrough Infections
So-called breakthrough infections are when fully vaccinated people still get COVID-19. In rare cases, such as former Secretary of State Colin Powell, who died of complications from COVID-19 yesterday, even fully vaccinated deaths can occur. In the case of General Powell, he was 84 and had multiple myeloma and Parkinson’s disease. Multiple myeloma is a blood cancer that attacks the white blood cells that produce antibodies, so even though he was fully vaccinated, he was undoubtedly immunocompromised, which undermined the ability of the vaccines to train his immune system to recognize the virus.
A recent study, which has yet to be peer-reviewed, looked at breakthrough infections in the immunocompromised, particularly people on active immunosuppressive treatment. Earlier research demonstrated that the immunocompromised have a lower vaccine efficacy, ranging from 63% to 90%. That was partly why the FDA granted authorization for a third booster shot to this population first.
The new research found that in about 1.2 million people who are fully vaccinated, 18% were immunocompromised. They had a median age of 58 years compared to 45 years in the non-immunocompromised cohort. And almost 63% of the immunocompromised cohort had more than one comorbidity or condition that put them at high risk of severe COVID-19. The biggest group were people who had organ transplants, rheumatologic or other inflammatory diseases. The incidence of breakthrough infection is about 0.9 per 100 person-years in immunocompromised people compared to 0.34 per 100 person-years in people non-immunocompromised, or about 2.4-fold higher risk.
WHO Program Plans to Buy Antivirals for as Low as $10 Per Course for Poorer Countries
A program led by the World Health Organization plans to secure antiviral drugs against COVID-19 for poorer countries. The program expects to pay as little as $10 per course, according to a draft document. Merck’s new therapy, molnupiravir, will probably be one of the drugs. The program is dubbed Access to COVID-19 Tools Accelerator (ACG-A) and hopes to deliver 1 billion COVID-19 tests to poorer countries and drugs to treat up to 120 million people worldwide.
The program is still in the planning phases. It will be sent to global leaders ahead of the G20 summit to be held in Rome at the end of October. The ACT-A will request the G20 and other donors for another $22.8 billion in funding until September 2022, which will support the program. To date donors have pledged $18.5 billion.
