This article was updated at 3:00pm EST on January 8, 2021.

Experts are working fast to learn more about the confirmed mutation of coronavirus disease 2019 (COVID-19), with a laboratory study suggesting that the vaccine from Pfizer and BioNTech may be effective against the strain1 and LabCorp receiving a CDC contract to provide genomic sequencing.2

The variant has become widespread in the southeast of England, accounting for 60% of recent infections in London, according to the CDC. It is currently being called severe acute respiratory syndrome coronavirus 2 variant of concern 202012/01 (SARS-CoV-2 VOC 202012-01).3 A second, similar variant has also been identified in South Africa, according to the CDC. Both variants have an N501Y mutation in the spike protein.3

On Friday, the FDA issued an alert to health care providers and clinical laboratory staff regarding the mutation, although they said the impact on molecular tests remains low.4 According to a press release, 3 currently authorized tests—the MesaBiotech Accula, the TaqPath COVID-19 Combo Kit, and the Linea COVID-19 Assay Kit—may be impacted by genetic variants of SARS-CoV-2, but the impact does not appear to be significant at this point. False negatives can occur with any molecular test if a mutation occurs in the part of the virus's genome that is assessed by that test, but the FDA said it is working with developers and conducting ongoing data analysis to evaluate all currently authorized molecular tests.4

Potential consequences of the mutation could include the ability to spread more quickly, the ability to evade detection by specific diagnostic tests, decreased susceptibility to therapeutic agents, and the ability to evade vaccine-induced immunity, which the CDC said would likely be the most concerning. The CDC said there is currently no evidence that the variant causes more severe illnesses or increases the risk of death.3

“There are about 23 genetic changes in this strain,” said professor of infectious diseases Robert Bollinger, MD, MPH, in a report from Johns Hopkins Medicine. “There’s some preliminary suggestion that it’s more [contagious], and, although that’s not proven, scientists are noticing a surge of cases in areas where the new strain is appearing, and there could be a connection.”5

Bollinger said that based on current knowledge, the antibodies created by the current vaccines should still work on the mutation. He added that if there were ever a major mutation, the vaccine development process is designed to accommodate changes when necessary.5 According to reporting by Reuters, a laboratory study conducted by Pfizer confirmed this, with the vaccine appearing to work against a key mutation in the new variant.1

The study, which is not yet peer reviewed, was conducted on blood taken from individuals who had received the vaccine. Its findings are limited because it does not look at the full set of mutations found in either of the new variants, although Phil Dormitzer, PhD, MD, vice president and chief scientific officer of viral vaccines at Pfizer Vaccines Research and Development, said the findings are encouraging.1

“So, we’ve now tested 16 different mutations, and none of them have really had any significant impact,” Dormitzer said in reporting by Reuters. “That’s the good news. That doesn’t mean that the 17th won’t.”1

According to Reuters, investigators plan to run similar tests to verify whether the vaccine is effective against other mutations and hope to have more data in the coming weeks.1

In an effort to gain further knowledge about the variants of COVID-19, LabCorp has been awarded a contract from the CDC to provide genomic sequencing of de-identified samples, a project that will help the CDC conduct a large-scale longitudinal genomic survey of the virus. The survey’s goal is to provide baseline information for national and state-level surveillance, help to define changes in transmission, identify new variants, and improve the public health response.2

According to a press release, LabCorp will sequence the genomes of random de-identified samples that test positive for SARS-CoV-2 and will provide the completed sequences to the CDC. These data will then be combined with the results of other efforts undertaken by national, state, academic, and private labs to meet the CDC’s goal.2

“Better decision making starts with better data, and we are eager to help the CDC in its efforts to improve the nation’s understanding of this virus and how to effectively fight it,” said Marcia Eisenberg, PhD, chief scientific officer at LabCorp, in a press release. “This sequencing survey is a critical project to ensure our knowledge of COVID-19 improves even as the virus may mutate and change.”2

Despite the concerns that may come along with mutations of the SARS-CoV-2 virus, experts say the new strains do not call for any new prevention strategies. Limiting the spread of the virus through precautions such as mask wearing and physical distancing will give the virus fewer chances to change, explained Stuart Ray, MD, vice chair of medicine for data integrity and analytics at Johns Hopkins.5

“We need to re-emphasize basic public health measures, including masking, physical distancing, good ventilation indoors, and limiting gatherings of people in close proximity with poor ventilation,” Ray said in the Johns Hopkins report. “We give the virus an advantage to evolve when we congregate in more confirmed spaces.”5

REFERENCES
  1. Erman M. Pfizer/BioNTech vaccine appears effective against mutation in new coronavirus variants – study. Reuters; January 7, 202 https://www.reuters.com/article/health-coronavirus-pfizer-vaccine/pfizer-biontech-vaccine-appears-effective-against-mutation-in-new-coronavirus-variants-study-idUSL1N2JI2LZ. Accessed January 8, 202
  2. Labcorp Awarded CDC Contract to Study Variants of COVID-19 Virus and Improve Public Health Response [news release]. BusinessWire; January 7, 2021. https://www.businesswire.com/news/home/20210107005887/en. Accessed January 8, 2021.
  3. Centers for Disease Control and Prevention. Interim: Implications of the Emerging SARS-CoV-2 Variant VOC 202012-01. Updated December 29, 2020. https://www.cdc.gov/coronavirus/2019-ncov/more/scientific-brief-emerging-variant.html. Accessed January 8, 2021.
  4. FDA Issues Alert Regarding SARS-CoV-2 Viral Mutation to Health Care Providers and Clinical Laboratory Staff [news release]. FDA; January 8, 2021. https://www.fda.gov/news-events/press-announcements/fda-issues-alert-regarding-sars-cov-2-viral-mutation-health-care-providers-and-clinical-laboratory. Accessed January 8, 2021. 
  5. A New Strain of Coronavirus: What You Should Know. Johns Hopkins Medicine; December 28, 2020. https://www.hopkinsmedicine.org/health/conditions-and-diseases/coronavirus/a-new-strain-of-coronavirus-what-you-should-know. Accessed January 8, 2021.