Solving COVID

Solving COVID: January 6, 2021

FDA rejects potential changes to COVID-19 vaccine regimen, India approves first 2 COVID-19 vaccines, and more

1

FDA rejects potential changes to COVID-19 vaccine regimen

The Food and Drug Administration has shot down suggestions to change COVID-19 vaccine regimens "at this time." FDA officials on Tuesday rejected numerous ideas that have been floated amid the slow U.S. vaccine rollout. Operation Warp Speed chief adviser Dr. Moncef Slaoui previously said the U.S. was looking at potentially administering two half doses of Moderna's vaccine to some Americans to immunize "double the number of people with the doses we have." Meanwhile, officials in Britain will allow more than 21 days between doses of Pfizer's vaccines and will consider allowing people to receive two different vaccines. FDA officials said "these are all reasonable questions to consider and evaluate in clinical trials. However, at this time, suggesting changes to the FDA-authorized dosing or schedules of these vaccines is premature and not rooted solidly in the available evidence."

2

India approves first 2 COVID-19 vaccines for emergency use

India has approved the COVID-19 vaccine developed by the University of Oxford and AstraZeneca for emergency use, Information and Broadcasting Minister Prakash Javadekar told reporters Saturday. Additionally, the government authorized the emergency use of a vaccine known as COVAXIN developed locally by Bharat Biotech and the government-run Indian Council of Medical Research. They're the first coronavirus vaccine candidates to get the green light in India, launching a massive immunization campaign in the world's second most populous nation, which has recorded the second largest number of COVID-19 infections after the United States. Little is known about the results of COVAXIN's clinical trials. India has two more vaccines awaiting approval, including Russia's Sputnik V, and the Pfizer-BioNTech shot.

3

Scientists home in on potential cause of rare COVID-19 vaccine allergic reactions

Scientists are homing in on the potential cause of allergic reactions to the Pfizer-BioNTech COVID-19 vaccine. The U.S. Centers for Disease Control and Prevention has recorded six severe allergic reactions (all of which were treated successfully) out of the 272,001 doses administered through Dec. 19, and the compound polyethylene glycol, known as PEG, has become a leading suspect in the cases. While still speculative at this point — allergies to PEG are rare and the reactions may have been to something else — PEG is found in other drugs, cosmetics, and food and is known to trigger anaphylaxis on rare occasions. PEG is also found in the Moderna vaccine. A health care worker, Dr. Hossein Sadrzadeh, became the first known person to experience an allergic reaction to that shot. He reported tingling sensations, an elevated heart rate, and low blood pressure shortly after his inoculation. He was discharged a few hours later. The incidents, while concerning, are rare, and scientists and public health officials maintain the vaccines are safe, effective, and crucial to ending the pandemic.

4

America's COVID-19 vaccine effort is 'total chaos,' vaccine expert says

The U.S. kicked off a second phase of its COVID-19 vaccine campaign on Monday, when health care workers and others at the top of the tiered system began getting their second doses. But the rollout of the inoculation effort has been slow and uneven. The Trump administration sought to vaccinate 20 million Americans by Jan. 1 — as of Jan. 4, only 4.5 million had gotten their first shot, out of 15 million doses distributed. States are struggling to match vaccine shots with the people who want and are qualified to get them. The effort has also been hampered by ineffective communication plans and the lack of any meaningful national outreach campaign. "It's total chaos," said Peter Hotez, a vaccine expert at the Baylor College of Medicine. The U.S. needs to inoculate about a million people a day to get the pandemic contained by September, and Hotez said the current plan won't achieve that. He believes the U.S. should scrap its tiered system and supplement the doses shipped to nursing homes and hospitals with mass vaccination venues, like sports stadiums, where anyone who wanted the vaccine could show up for a shot.

5

FDA warns COVID-19 test used by Congress is 'particularly' prone to false negative results

The Food and Drug Administration alerted health care providers and patients this week that a COVID-19 diagnostic test made by Curative poses a "risk of false results, particularly false negative results." The House and Senate screen members, staff, and reporters covering Capitol Hill with the Curative test, so when Congress is in session that means dozens, sometimes even hundreds of people, use it to determine if they're infected. The FDA is now saying the test should not be used as the only data point "for treatment or patient-management decisions" and suggested limiting its use for people displaying symptoms for 14 days or fewer. Brian Monahan, the Capitol physician, acknowledged the warning in a Monday memo, but said Curative's test is "the most accurate available" and false results are a risk faced by all coronavirus tests.

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