BA.5 Update: Caseloads, Public Health Policies, and Vaccines and Therapies

The BA.5 sub-lineage of Omicron is quickly spreading internationally and nationally in the United States.

“Among #Omicron lineages, #BA5 & BA4 continue to rise globally. BA.5 has been detected in 83 countries, with prevalence from 37% to 52% from 19 to 25 June. The rate of BA4 is not as high as BA5,” Maria Van Kerkhove, PhD, World Health Organization (WHO) COVID-19 technical lead, emerging diseases and zoonoses lead, WHO Health Emergencies Program tweeted earlier this week.

Here in the United States, BA.5 has become the predominant strain and is estimated to make up 65.0% of the variants as of last week, Centers for Disease Control and Prevention (CDC) Director Rochelle Walensky, MD, MPH, said in a press conference on Tuesday. She said the BA.5 and BA.4 variants together accounted for more than 80.0% of circulating variants, with BA.4 making up 16.3%. The other subvariants, BA.2.12.1, makes up 17.3% of the cases, and BA.2 is 1.4% of the cases in the most recent reporting week (ending July 9).

National Plan
On Tuesday, the White House released a statement discussing its response to BA.5. “To confront BA.5, the Administration will continue mobilizing the full strength and capabilities of the federal government and working with state and local leaders, health care workers, the private sector, and community- and faith-based organizations to ensure that the American people have easy and convenient access to and use vaccines, tests, and treatments,” The White House statement read.

Specifically, the Biden Administration has 7 specific areas they are looking to focus on, and they include:

• Making it easy for people to get vaccines and boosters
• Making it easy to access COVID-19 treatments and boost provider and patient awareness
• Making free COVID-19 testing, including at-home tests, widely available
• Making free high-quality masks widely available and communicate clear recommendations about when people should consider masking
• Prioritizing protections for immunocompromised individuals
• Encouraging all building owners to improve indoor ventilation
• Empowering people with the latest information on COVID-19 and where to access vaccines, treatments, tests, and masks at COVID.Gov

COVID-19 Vaccine and Therapy
The Food and Drug Administration (FDA) authorized the Novavax COVID-19 vaccine late yesterday. The vaccine is indicated as a two-dose primary series to prevent the virus in individuals 18 years of age and over.

This vaccine is protein-based and made up of genetic original SARS-CoV-2 strain sequencing, with antigen derived from the Spike protein and formulated with a proprietary Novavax adjuvant designed to improve immune response and increase neutralizing antibody levels.

This vaccine can serve as an alternative to the mRNA vaccines, which some people may be reluctant to get.

The federal government secured an initial 3.2 million doses of the Novavax vaccine earlier this week, with plans to make them available for free to the public.

Today is the Prescription Drug User Fee Act (PDUFA) date for Regeneron’s casirivimab and imdevimab (Regen-Cov) antibody therapy. Regen-Cov was initially given an Emergency Use Authorization (EUA) in 2020 and the authorization was amended last year as post-exposure prophylaxis for COVID-19 in adults and pediatric individuals (12 years of age and older weighing at least 40 kg) who are at high risk for progression to severe COVID-19, including hospitalization or death.

In January of this year, the FDA amended the EUA again, “ to exclude its use in geographic regions where, based on available information including variant susceptibility and regional variant frequency, infection or exposure is likely due to a variant such as Omicron (B.1.1.529) that is not susceptible to the treatment.” With that EUA revision, Regen-Cov was not authorized for use in the US.

In studies prior to the Omicron predominance, the therapy was efficacious. In one trial it reduced the risk of contracting symptomatic COVID-19 by 81.4% during the first month after administration and 81.6% during the 2-8 months following the injections.