April 29, 2021

COVID-19 Update


KEY TAKEAWAYS

  • More than half of all U.S. adults have received at least one COVID-19 vaccine dose, and more than one-third are fully vaccinated.
  • The U.S. is administering about 2.7 million vaccines doses per day.
  • The coronavirus pandemic has reinforced the value of American innovation and what can be achieved when the federal government works with the private sector. These partnerships have produced effective treatments and testing for the COVID-19.

More than half of the United States adult population has received at least one dose of coronavirus vaccination, and more than one-third are fully vaccinated. As a result of the investments made by Congress, and through the efforts of Operation Warp Speed, coronavirus testing is widespread and readily available. Safe and effective treatments and vaccines have been developed and authorized, and about 2.7 million vaccine doses are being administered each day.

Vaccines

The three vaccines currently authorized by the FDA for emergency use – Pfizer, Moderna, and Johnson & Johnson – are highly effective at protecting against COVID-19. This month, Pfizer and Moderna announced updates on the efficacy of their vaccines. Pfizer reported that, among people who got their second dose between seven days and six months earlier, the vaccine was 91% effective against the disease. Moderna said that its vaccine is more than 90% effective against the virus up to six months after the second dose. These two vaccines account for 92% of fully vaccinated people in the U.S.

On March 31, Pfizer announced positive results from the phase 3 clinical trial of its vaccine in children 12-15 years old. The manufacturer has requested the FDA expand its authorization to allow the vaccine to be given to children in this age group. Moderna and Johnson & Johnson also have started testing their vaccines in younger children. Drug makers are studying their vaccines against variants of the virus as they emerge. Dr. Anthony Fauci, the president’s chief medical adviser, predicts that by the end of the summer we will know if booster shots are needed to protect people against new coronavirus variants.

Still Effective up to Six Months after Second Dose

COVID-19 Update

On April 13, the Centers for Disease Control and Prevention and the FDA recommended a “pause” on administering the Johnson & Johnson vaccine after six women reportedly developed rare blood clots and low platelet levels after getting the shot. The patients experienced symptoms six to 13 days after they got the vaccine. During the pause, an additional nine cases of this condition, known as thrombosis-thrombocytopenia syndrome, were reported. Nearly seven million Americans received the J&J vaccine before the recommended pause. On April 23, following a meeting of the Advisory Committee on Immunization Practices, the FDA and CDC lifted the pause. The FDA and Johnson & Johnson are updating the vaccine’s label to include information about TTS. The European Medicines Agency, the European Union’s drug regulator, also determined on April 20 that the benefits of the vaccine outweigh the risks and required an update to the label regarding the potential for blood clots.

testing

Testing for SARS-CoV-2, the virus that causes COVID-19, is more accessible than it was at the beginning of the pandemic. Last year, Congress appropriated $33.4 billion for testing, and the CARES Act required that coronavirus tests be provided at no cost to patients. The FDA has authorized 369 tests and sample-collection devices. It has authorized seven antigen tests and two molecular tests for serial screening to detect asymptomatic infection. These tests are helping schools, workplaces, and communities to safely reopen.

The Rapid Acceleration of Diagnostics, or RADx, initiative led by the National Institutes of Health in coordination with the Biomedical Advanced Research and Development Authority has supported the development and availability of tests, working with private partners to offer reliable and affordable options. The RADx program is now supporting the production of nearly two million diagnostic tests per day, including more than 500,000 point-of-care tests. So far, 716 applications have been submitted to the initiative and 32 projects have advanced through the second stage of review. Most recently, RADx launched an initiative to supply rapid at-home tests to assess the benefits of self-administered coronavirus testing. The FDA authorized an at-home diagnostic test developed by Quidel for sale without a prescription that gives results in 10 minutes using a nasal swab sample.

The Trump administration took action to stop the spread of the virus, restricting the entry of foreign nationals traveling from certain areas and requiring international travelers to show proof of a negative test prior to entry into the United States. The Biden administration has continued these policies. The CDC updated its travel guidance on March 26. It now recommends that fully vaccinated people can travel at low risk to themselves and do not need coronavirus testing or post-travel quarantine. International travelers must still have a negative coronavirus test before flying to the U.S. and must test within days of returning from travelling abroad. 

treatments

Unprecedented focus and financial investment has been directed at developing effective COVID-19 treatments. FDA has approved one drug to treat COVID-19, and given emergency use authorization for 10 other treatments.

Treatment for COVID-19 has shifted as scientists have learned more about it. Most recently, Eli Lilly requested the FDA revoke authorization for use of its antibody drug, bamlanivimab, when administered without etesevimab. The drug was developed last year and received FDA authorization in November. Eli Lilly was also developing an antibody cocktail that combines bamlanivimab with etesevimab, and it found that the cocktail is more effective. The FDA authorized combined use of the antibody treatments in February and then granted the revocation request for the drug on its own.

Issue Tag: Health Care