John Parkinson

SARS-CoV-2, B.1.1.7, or otherwise known as VOC 202012/01, which was discovered in 

 may lead to a large increase in the number of COVID-19 cases in the US and may become the dominant strain of the virus in the coming months, according to a Centers for Disease Control and Prevention (CDC) report released today.

“The increased transmissibility of this variant requires an even more rigorous combined implementation of vaccination and mitigation measures (e.g., distancing, masking, and hand hygiene) to control the spread of SARS-CoV-2,” the CDC wrote in its report. “These measures will be more effective if they are instituted sooner rather than later to slow the initial spread of the B.1.1.7 variant.”

The B.1.1.7 variant has been spreading across the globe, but has been limited in the United States, thus far. The variant has been reported in 76 cases and discovered in 10 states. However, it is believed that the number of cases is actually much higher.

Investigators have said B.1.1.7 is more contagious than the original virus, but no determination has been made that this variant can lead to severe cases and higher mortality.

The CDC said the UK variant is spreading faster than other variants and points to B.1.1.7 potentially becoming the dominant virus in just a matter of weeks. The agency pointed to projections in its 

“In this model, B.1.1.7 prevalence is initially low, yet because it is more transmissible than are current variants, it exhibits rapid growth in early 2021, becoming the predominant variant in March,” the CDC wrote in the report.

Earlier this week, concerns over COVID-19 transmissibility 

 to require all air travelers flying into the United States to have proof of a negative COVID-19 test before being able to board for flight.

 (a test for current infection) within the 3 days before their flight to the US departs, and provide written documentation of their laboratory test result (paper or electronic copy) to the airline or provide documentation of having recovered from COVID-19.

Airlines must confirm the negative test result for all passengers or documentation of recovery before they board. If a passenger does not provide documentation of a negative test or recovery, or chooses not to take a test, the airline must deny boarding to the passenger.

This policy goes into effect on January 26.

 that the US did not have reserve doses of the BNT162b2 and mRNA-1273 COVID-19 vaccines that were supposed to be prepared for the second-dose administration of prioritized recipients earlier this week.

In fact, this stockpile was actually distributed at the end of December.

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The CDC is saying this highly contagious variant, B.1.1.7, may become the dominant strain of the virus by March.

United Kingdom COVID-19 Variant May Lead to Spikes in Cases

After a single dose vaccination, Johnson & Johnson’s (J&J) JNJ-78436735 COVID-19 vaccine showed neutralizing antibodies against COVID-19 in over 90 percent of study participants at Day 29 and 100% of participants aged 18-55 years at Day 57. 

These neutralizing antibodies remained stable through Day 71, currently the latest timepoint available in this ongoing study, in all participants aged 18-55 years.

The company plans to release data in participants 65 years and older in late January.

The single dose investigational vaccine, which is being developed by the Janssen Pharmaceutical Companies of Johnson & Johnson, is more commonly referred to as the Ad26.COV2.S vaccine, and is a recombinant, replication-incompetent adenovirus serotype 26 (Ad26) vector encoding a full-length and stabilized SARS-CoV-2 spike (S) protein.

The phase 1/2a analysis showed that the company’s COVID-19 vaccine candidate was generally well-tolerated across all study participants.

While the vaccine is being studied as a single dose administration shot, the trial did evaluate 2 dose administration. The data showed that a second dose of JNJ-78436735, administered 56 days apart, was less reactogenic while it triggered more than a two-fold increase in antibodies against COVID-19.

“Although all ongoing phase 3 studies of other Covid-19 vaccines have assessed two-dose schedules, a single dose of Ad26.COV2.S elicited a strong humoral response in a majority of vaccine recipients, with the presence of S-binding and neutralizing antibodies in more than 90% of the participants, regardless of either age group or vaccine dose,” the investigators wrote.

The vaccine is built upon the company’s AdVac platform, which was used for its Ebola vaccine.

J&J said it believes it will be able to announce topline phase 3 data for its vaccine in late January 2021, and if it is shown to be safe and effective, the company expects to submit an application for Emergency Use Authorization (EUA) with the US Food and Drug Administration (FDA).

With this news, there has been speculation this could lead to the FDA setting a date for a Vaccines and Related Biologic Products Advisory Committee (VRBPAC) meeting in February to discuss whether or not they would grant the vaccine an EUA.

This vaccine is meant to be delivered as a single dose administration as compared to other vaccines that have been authorized and in development that require a booster shot.

J&J COVID-19 Vaccine Shows a 90% Immune Response in Interim Data

The Centers for Disease Control and Prevention (CDC) is requiring all air travelers flying into the United States to have proof of a negative COVID-19 test before being able to board for flight.

 (a test for current infection) within the 3 days before their flight to the US departs, and provide written documentation of their laboratory test result (paper or electronic copy) to the airline or provide documentation of having recovered from COVID-19. Airlines must confirm the negative test result for all passengers or documentation of recovery before they board. If a passenger does not provide documentation of a negative test or recovery, or chooses not to take a test, the airline must deny boarding to the passenger.

This order was signed by the CDC Director Robert Redfield, MD, today and will become effective on January 26, 2021.

“Testing does not eliminate all risk,” Redfield said in a statement. “But when combined with a period of staying at home and everyday precautions like wearing masks and social distancing, it can make travel safer, healthier, and more responsible by reducing spread on planes, in airports, and at destinations.”

This policy comes on the heels of a requirement given back in late December by the administration, “requiring air passengers arriving from the United Kingdom (UK) to test negative, via PCR or Antigen test, no more than 72 hours before departure from the UK to the United States,” according to a CDC statement.

, or otherwise known as VOC 202012/01, was discovered that same month in the UK, but has spread to other countries.

The agency says all travelers must show proof of negative test before boarding.

CDC Requires All Flyers to US to Test Negative for COVID-19

The US Food and Drug Administration (FDA) will review a Biologics License Application (BLA) for V114, Merck’s investigational 15-valent pneumococcal conjugate vaccine, for the prevention of invasive pneumococcal disease in adults 18 years of age and older.

The FDA set a Prescription Drug User Fee Act (PDUFA) date for July 18, 2021.

“Building on our nearly 40 years of experience with PNEUMOVAX 23, Pneumococcal Vaccine Polyvalent, we have developed V114 as another potentially important option to help protect more adults from invasive pneumococcal disease, especially those who are at increased risk," Roy Baynes, MD, PhD, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories, said. "We look forward to working with the FDA during the review of this application.”

The BLA and priority review designation are supported by results from phase 2 and Phase 3 clinical studies in a variety of adult populations, including healthy adults and those at increased risk, such as adults with chronic medical conditions, adults with HIV, and those 65 years of age and older.

One of the phase 3 studies was the PNEU-AGE (V114-019) trial, which enrolled healthy adults 50 years of age or older. The trial demonstrated the vaccine was non-inferior to the currently available 13-valent pneumococcal conjugate vaccine (PCV13) for the 13 serotypes targeted by both vaccines and superior for serotypes 22F and 33F, the two serotypes targeted by V114 but not PCV13.

The company’s other phase 3 trial, PNEU-TRUE (V114-020), also used healthy adults 50 years of age or older. The vaccine met its primary immunogenicity objective demonstrating equivalent immune response across all 15 serotypes for three different lots of V114.

In both studies, the vaccine was generally well tolerated, with a safety profile comparable to PCV13 and consistent with that observed for V114 in previously reported studies.

In addition to the FDA review, the European Medicines Agency is also reviewing an application for V114.

The agency set a PDUFA date for July 18 for Merck's V114 vaccine.