January 29, 2021

COVID-19 Weekly Newsletter: New Vaccines on the Horizon as COVID-19 Variants Pose Continued Challenges

As we approach the one-year mark of COVID-19’s widespread presence in the United States, vaccines are being distributed, manufacturing is increased to meet demand and news of new vaccines all looks promising. While the world continues to battle against the pandemic, new variants of COVID-19 are cropping up, raising concerns about the efficacy of these vaccines. As scientists continue to learn more about the variants, the uptick in strains prompts new travel restrictions in the U.S.

Moderna to Test Booster on New Variant

With the new COVID-19 variants being identified, Moderna has planned to conduct human studies of a booster shot for its already two-dose vaccine that was authorized for emergency use in the United States at the end of December. From tests conducted at the National Institutes of Health (NIH), Moderna says its vaccine produced six-fold lower levels of neutralizing antibodies against the South Africa variant called B.1.351 than it did against the original COVID-19 strain, but the study results suggested the immunity may wane more quickly. Meanwhile, Moderna said there was no reduction in antibodies against the rapidly spreading U.K. variant called B.1.1.7. That variant is widespread in the U.K. and is expected the become the dominant strain.

Travel Bans due to New Strain Variant

January marked the deadliest month from COVID-19 in the United States and marked the introduction of variant strains seen in numerous countries. In response to this, President Biden announced a ban on travel from South Africa, Brazil, United Kingdom, Iran, China and many European countries went into effect.

More Vaccines to States

Per Centers of Disease and Control and Prevention’s data, West Virginia and North Dakota have been incredibly efficient in using 75% of their supply of vaccines that they have gotten from the federal government. President Biden hopes 100 million vaccines will be administered by April, promising to provide states with more doses. President Biden is targeting to increase vaccine production capacity in order to inoculate 300 million Americans by the end of summer/early fall.

Merck to Suspend COVID Vaccine Development

This week, Merck officially called it quits on developing its two COVID-19 vaccines after seeing poor results from their Phase 1 clinical trials. However, they will continue to develop two investigational therapeutics to aid in the pandemic response.

Novavax Vaccine Effective Against UK and South African Variant

Novavax reported this week that their protein-based vaccine has a combined 89.3% efficacy in its United Kingdom Phase 3 clinical trial — 95.6% against the original COVID-19 strain and 85.6% against the U.K. variant strain. In addition, Novavax reported 60% efficacy in its Phase 2b clinical trial in South Africa; while this number may seem low (but still above the WHO 50% threshold), it is important to note that preliminary sequencing from the COVID-19 cases from the placebo and vaccine groups showed that over 90% were caused by the new South African variant strain. Novavax is already developing candidates to target these emerging strains as a booster or combination vaccine and will begin clinical testing later this year.

Single-Dose Johnson & Johnson Vaccine 66% Effective

Johnson & Johnson (J&J) announced today that their single-dose vaccine was 66% effective overall in preventing moderate to severe COVID-19. Like the other vaccines, the J&J vaccine displayed lower efficacy against the South African variant of COVID-19. It was noted that none of the COVID-19 cases reported in the study after 28 days post-vaccination required hospitalization or resulted in death.

Online Neurological Symptoms Databases and Vaccine Trackers

The NIH has launched a database to track neurological symptoms of COVID-19, capturing blinded information from clinicians as well as bio-specimens. The information will help increase understanding of COVID-19 related neurological problems, from which many have suffered.

The CDC and Johns Hopkins University have set up vaccine trackers that provide information on the number of vaccinations per state, county, and other regions. These resource pages also information on how vaccines are developed, the different types of vaccines, and how safety and efficacy are determined.

COVID-19 Variants: Vaccine Effectiveness, Tracking and Identification

Researchers across the globe have worked to identify SARS CoV-2 variants that appear to be more contagious than other forms of the virus. These include the variant first identified several weeks ago in the U.K. (B.1.1.7), and two more recently identified in travelers from Brazil (P.1) and in South African patients (B.1.351).

In yet to be published studies, Moderna and Pfizer-BioNTech have indicated that their vaccines show similar efficacy toward B.1.1.7 as toward earlier forms, but have reported in vitro study results in which sera from vaccinated individuals are slightly less neutralizing toward the B.1.351 variant than toward other virus forms.

The P.1 variant, which shares some mutations with the B.1.251, was recently found in a US patient. The B.1.351 variant was just identified in individuals in South Carolina.

The news again highlights the importance of international information sharing about the virus and the disease effects, and specifically the importance of national, coordinated, conscientious and vigorous approaches to genomic sequencing and surveillance. Efforts such as the UK-wide COVID-19 Genomics Consortium (COG-UK) and the GISAID database have played key roles in identifying variants, which impact public health actions and vaccine/therapy development. The US currently does not have a coordinated national effort for genomic surveillance.

In recent studies, researchers have mapped mutations to the SARS CoV-2 receptor-binding domain (RBD), which helps the virus invade cells. Mutations were identified that allow the RBD to “escape” interaction with certain antibody therapies. One of these mutations is found on the B.1.351 variant. Such studies provide complementary information to genomics surveillance, helping researchers to more quickly identify potential impacts of specific mutations.

In a statement made this week, acting FDA Commissioner Janet Woodcock noted that FDA continues to consider impact of variants on authorized medical products including vaccines, and provides assurances of authorized vaccines effectiveness toward current virus strains.

Hospitalized COVID-19 Patients Shed Viable Virus for Approximately Two Weeks After Symptom Onset

The time course of the COVID-19 illness is still an open question. A study has now been published addressing one aspect of that question — how long do hospitalized patients continue to shed viable virus and thereby stay infectious to those around them? The precise answer depends on the clinical conditions, term definitions, chosen thresholds and bio-analytical methods used for a given study. For the conditions described in this particular study, the virus shedding continues, on average, a week after the onset of symptoms and could be as long as two weeks, depending on the patient. These numbers could be revised as similar studies are conducted in other locations with different patients and different test methods, eventually leading to a more generalizable answer.

Real-World Evidence of Vaccination Is Emerging

While clinical trials that were the basis of the current COVID-19 vaccines’ approvals demonstrated sufficient efficacy and safety to justify the broad roll out of those vaccines to the public, real-world situations may, and do, deviate from the tightly controlled and circumscribed clinical-trial conditions. There is much interest, therefore, in learning the effect of country-wide vaccination campaigns on people’s health and on the progression of the pandemic. First reports indicate that the incidence of positive COVID-19 tests is lower in those who have been vaccinated (although only by a third) two weeks after the first. More robust protection is expected after the second shot.

Faster-Spreading SARS-CoV-2 Variants Can Dodge Immune System’s Defenses

Researchers studied how well the antibodies in convalescent plasma neutralize the more transmissible variant of SARS-CoV-2 that is spreading in several countries. So far, the results indicate that the mutated virus is able to bypass antibodies developed in response to previous infections. Studies are ongoing to determine the efficacy of antibodies from mRNA vaccines against the mutated virus variants. Some researchers are already suggesting that the composition of those vaccines themselves may need to be updated regularly to keep up with the virus, similar to how flu vaccines need to be fine-tuned before every flu season.

More COVID-19 Insights

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Additional Resources

Global COVID-19-Related Patent Office Status and Deadline Extension Updates

Information regarding the status of each foreign patent office and the availability of extensions of time in each jurisdiction.

Government Actions: COVID-19

Tracking executive orders, legislation, and other government actions related to COVID-19 by state and major locality across the U.S.

Tracking Fraud Related to the COVID-19 Pandemic

Tracking federal and state law enforcement and regulatory actions taken against bad actors who have exploited the COVID-19 emergency to defraud consumers and payers.

Faegre Drinker’s Coronavirus Resource Center is available to help you understand and assess the legal, regulatory and commercial implications of COVID-19.
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