New Developments in COVID-19 Vaccine, Testing, and Treatment Review

The US Has Administered Over 220 Million COVID-19 Vaccine Shots

In his address to a Joint Session of Congress, on April 28, 2021, President Biden announced that the US had administered over 220 million COVID-19 vaccines in his first 100 days in office. The President noted that vaccines had been distributed to nearly 40,000 pharmacies and over 700 community health centers.

The US vaccination campaign, among the world’s largest against COVID-19, has resulted in almost 70% of US seniors being fully vaccinated and, as noted by the President, 90% of Americans now live within 5 miles of a vaccine site. Additionally, all US adults over the age of 18 have been eligible for COVID-19 vaccines since April 19, 2021, and, per data from the Centers for Disease Control and Prevention (CDC), the US had fully vaccinated 30% of its population and given at least one dose to 43.3% percent of its population (38.4% and 54.9%, respectively, among US adults over the age of 18) as of April 29, 2021.

Pfizer Obtained EUA for Its Vaccine in Adolescents Aged 12-15 Years

In one of the first trials of a COVID-19 on adolescents, Pfizer, on March 31, 2021, announced that its COVID-19 vaccine was both well-tolerated and 100% effective against symptomatic COVID-19 infection, for adolescents aged 12-15. The Phase 3 clinical trial of Pfizer’s very successful COVID-19 vaccine (95% efficacy in adults) revealed no adverse side effects in the adolescents and zero cases of symptomatic COVID-19 among the vaccine recipients in the trial. Pfizer immediately went to work with the Food and Drug Administration (FDA) to amend its Emergency Use Authorization (EUA), to get its vaccine authorized for adolescents aged 12-15 years and the EUA for this age group was granted on May 10, 2021.

GSK and Vir Biotechnology Submitting EUA for Early COVID Treatment

On March 26, 2021, GlaxoSmithKline plc (GSK) and Vir Biotechnology, Inc. announced the submission of an application for an EUA from the FDA for VIR-7831 (GSK4182136), a monoclonal antibody treatment for early-stage COVID-19. GSK and Vir applied for the EUA after interim analysis from a Phase 3 trial, which showed that VIR-7831 was 85% effective at reducing hospitalization or death, compared to a placebo. VIR-7831 is primarily designed for adults and adolescents over 12, who have a high risk of hospitalization or death from COVID-19 and currently have mild-to-moderate COVID-19 symptoms. The drug also showed efficacy, in vitro, against the UK, South African, and Brazilian variants of the virus.

FDA Approves Over-the-Counter, Take Home COVID-19 Tests for Asymptomatic Infection

On March 31, 2021, the FDA announced that it had authorized, through EUAs, multiple over-the-counter, non-prescription, COVID-19 tests for serial screening. Some of these tests were also authorized for use in point-of-care settings. The FDA noted that:

“Screening testing, especially with the over-the-counter tests authorized today, is an important part of the country’s pandemic response—many schools, workplaces, communities, and other entities are setting up testing programs to quickly screen for COVID-19.”

In announcing the EUAs, the FDA noted the rigorous standards the tests from Quidel, Abbott, and BD Veritor went through, with Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health, stating “[a]s we’ve said all along, if it’s a good test, we’ll authorize it.”

15 Million Doses of Johnson & Johnson COVID-19 Vaccine Ruined

On March 31, 2021, The New York Times broke the story that the ingredients for 15 million doses of the Johnson & Johnson (J&J) COVID-19 vaccine had been contaminated at the J&J plant run by Emergent BioSolutions in Baltimore. The FDA, in the process of certifying the plant for COVID-19 vaccine production (J&J also has a plant in the Netherlands, where all its vaccine has come from so far), discovered that some of the ingredients for J&J’s vaccine had been contaminated with ingredients for AstraZeneca’s vaccine, who shares the facility with J&J.
 
While the mistake was attributed by the FDA to human error, it delayed authorization of the plant for the production of J&J’s vaccine and 15 million doses of J&J’s vaccine were lost in the process. In a statement the night of March 31, J&J reiterated its production commitment of 100 million doses to the US Government by the end of May, noting that the problems discovered by the FDA were part of the standard quality control process for its vaccine.

FDA Paused and Then Resumed Use of J&J Vaccine

On April 13, 2021, the FDA recommended that US states pause the use and administration of the J&J COVID-19 vaccine, due to the risk of a very rare blood clot disorder, affecting six women and resulting in one death at the time. The FDA “out of an abundance of caution” recommended pausing the use of the J&J vaccine, so it and the CDC had time to investigate the symptoms, affecting approximately one in a million recipients of the vaccine in the US. The pause was also partially due to the interaction with the drug heparin, which is commonly used to treat blood clots, but in this instance, could be dangerous for patients experiencing such clots.

On April 23, 2021, after a 10-day pause in the administration of the J&J vaccine, the FDA and the CDC’s Advisory Committee on Immunization Practices lifted the pause. The FDA and CDC expressed “confidence that this vaccine is safe and effective in preventing COVID-19” and the FDA determined “that the available data show that the vaccine’s known and potential benefits outweigh its known and potential risks in individuals 18 years of age and older.” Such complications, the FDA and CDC noted, are very low, had only affected women between the ages of 18-59, and were now included in the fact sheets provided to caregivers regarding the vaccine. It is too early to determine how the pause affected administration and uptake of the J&J vaccine in the US; although, it is important to note that the J&J vaccine only made up less than 5% of US vaccinations, prior to its pause on April 13.

Moderna Meeting its Shipping Target to US for March and On Pace for May/July

On March 29, 2021, Moderna announced that its shipped the 100 millionth dose of its COVID-19 vaccine (over 94% efficacy in adults) to the US. Government. In its announcement, Moderna noted that, per the Centers for Disease Control and Prevention, over 67 million doses of the Moderna vaccine had been administered in the US. Also, Moderna confirmed its forward-looking guidance on vaccine production, stating that it expected to meet its commitment to the US Government of an additional 100 million doses by the end of May and another 100 million doses by the end of July. Moderna is expecting to ship 40-50 million doses a month to the US Government.

GSK Helping to Manufacture 60 Million Does of Novavax’s Vaccine in UK

GSK announced on March 29, 2021, that it had reached an agreement with Novavax, to manufacture up to 60 million doses of Novavax’s COVID-19 vaccine, at its UK facility in Barnard Castle, for use in the UK GSK plans to provide fill and finish capability for the Novavax vaccine starting in May, with the companies beginning an intellectual property transfer immediately. This partnership will help Novavax meet its commitment of 60 million doses to the UK Government since GSK’s facility in Barnard Castle is already equipped to provide fill and finish capability for vaccines. The Novavax vaccine has shown in Phase 3 clinical trials to be effective against the UK variant of COVID-19.