Your Coronavirus Update for December 10; stay up to date with Elite.
More than 67.3 million cases of coronavirus (COVID-19) have been diagnosed worldwide as of Monday evening, including at least 1.54 million deaths. Healthcare officials in the United States have reported more than 14.9 million positive COVID-19 cases and at least 283,000 deaths. Source: Johns Hopkins University & Medicine
FDA Approves COVID & Flu At-Home Kit
The first diagnostic test for at-home collection of patient samples to detect both COVID-19 and influenza A and B have been authorized by the U.S. Food and Drug Administration (FDA). The test is for prescription use with a self-collection kit by the Quest Diagnostics by individuals who are suspected of respiratory viral infection consistent with COVID-19 when home collection is determined to be appropriate by an individual’s healthcare provider, according to FDA officials. Under a healthcare provider’s order, patients can collect a sample at home and ship it to a laboratory for analysis.
“[The] authorization for a COVID-19 plus flu test using samples collected at home is a significant step toward FDA’s nationwide response to COVID-19,” said Stephen M. Hahn, MD, commissioner of the FDA. “With the authorization of this test, the FDA is helping to address the ongoing fight against COVID-19 while in the middle of the flu season, which is important for many, including the most vulnerable of Americans. This is another example of the FDA working with test developers to bring important diagnostics to Americans.”
The test is conducted with one swab and is expected to detect positive cases more quickly while allowing patients to quarantine while awaiting their results.
Was COVID In The U.S. As Early As December 2019?
Samples from blood donors dating back to 2019 had evidence of coronavirus, according to a recent study conducted by the U.S. Centers for Disease & Prevention (CDC).1
The study analyzed blood donations from the American Red Cross that were collected from nine states. Researchers reportedly discovered evidence of coronavirus antibodies in 106 of the 7,389 blood donations collected between Dec. 13, 2019, and Jan. 17, 2020.
Of the 7,389 samples, 106 were reactive by pan Ig, according to CDC officials. Of these 106 specimens, 90 were available for further testing. Eighty four of 90 had neutralizing activity, 1 had S1 binding activity, and 1 had receptor binding domain/Ace2 blocking activity >50%, suggesting the presence of reactive antibodies.1 Donations with reactivity occurred in all nine states, the study found.
However, the researches did note that the possibility of false-positives exists and that there could be cases in which other common coronaviruses were the cause of the positive tests.
COVID Vaccine Gets First Global Approval
A temporary authorization for emergency use of the COVID-19 vaccine produced by Pfizer Inc. and BioNTech SE has been granted by the Medicines & Healthcare Products Regulatory Agency (MHRA) in the UK. The announcement constitutes the first emergency use authorization following a worldwide Phase 3 trial of the vaccine. Pfizer and BioNTech officials said they are anticipating further regulatory decisions across the globe in the coming days and weeks in anticipation of delivering vaccine doses following potential regulatory authorizations or approvals. The distribution of the vaccine in the U.K. will be prioritized according to the populations identified in guidance from the Joint Committee on Vaccination and Immunisation, officials recently said in a prepared statement. Announcement of the authorization came Dec. 2.
“Today’s emergency use authorization in the UK marks a historic moment in the fight against COVID-19,” said Albert Bourla, chairman and chief executive officer of Pfizer. “As we anticipate further authorizations and approvals, we are focused on moving with the same level of urgency to safely supply a high-quality vaccine around the world. With thousands of people becoming infected, every day matters in the collective race to end this devastating pandemic.”
The MHRA’s decision is reportedly based on a rolling submission, including data from the Phase 3 clinical study, which demonstrated a vaccine efficacy rate of 95% (p<0.0001) in participants without prior infection (first primary objective) and in participants with and without prior infection (second primary objective), in each case measured from seven days after the second dose. The first primary objective analysis is based on 170 cases of COVID-19, as specified in the study protocol, officials said. Efficacy was reportedly consistent across age, gender, race, and ethnicity demographics, with an observed efficacy in adults ages 65 and older of more than 94%. In the trial, the vaccine was reportedly well tolerated in general with no serious safety concerns reported.
Delivery of 40 million doses is expected to occur throughout 2020 and 2021, in stages, to ensure an equitable allocation of vaccines across the geographies with executed contracts, officials said.
The companies have also filed a request for emergency use authorization with the U.S. Food and Drug Administration and have submitted the final conditional marketing authorization application following rolling submissions with the European Medicines Agency and several other regulatory agencies around the world, officials said. “The emergency use authorization in the UK will mark the first time citizens outside of the trials will have the opportunity to be immunized against COVID-19,” said Ugur Sahin, MD, chief executive officer and co-founder of BioNTech. “We believe that the rollout of the vaccination program in the UK will reduce the number of people in the high-risk population being hospitalized. Our aim is to bring a safe and effective vaccine upon approval to the people who need it. The data submitted to regulatory agencies around the world are the result of a scientifically rigorous and highly ethical research and development program.”
Thank you for joining us for Your Coronavirus Update for December 10; if you missed last week’s article, please consider reading it here.
1. Basavaraju SV, Patton ME, Grimm K. Serologic Testing of U.S. Blood Donations to Identify SARS-CoV-2-reactive Antibodies: December 2019-January 2020. Clinical Infectious Diseases. Accessed online: https://academic.oup.com/cid/advance-article/doi/10.1093/cid/ciaa1785/6012472