Moderna Says Vaccine Benefits Outweigh Risk Of Rare Heart Conditions

Bloomberg: Moderna Defends Covid Shot As Questions On Heart Risks Mount
Moderna Inc. held a brief conference call to defend the safety of its Covid-19 shot from a barrage of questions about associated heart risks in young people. Chief Medical Officer Paul Burton acknowledged on the call that the company’s vaccine does appear linked to increased chances of an inflammatory heart condition known as myocarditis in young men. Moderna maintains that the shot’s benefits continue to outweigh the extremely rare risk of myocarditis, he said Thursday. (Griffin, 11/11)

CNBC: Moderna Says Covid Vaccine Has Fewer Breakthrough Cases Than Pfizer's
Moderna defended the use of its covid-19 vaccine Thursday, saying the protection it offers against severe disease, hospitalization and death outweighs the risk of myocarditis, a rare heart condition seen in a small number of young men who received the shot. The company announced last week that the Food and Drug Administration needed more time to decide whether to authorize its two-dose vaccine for use in children ages 12 to 17 as the agency looks into reports of myocarditis, or the inflammation of the heart muscle. (Lovelace Jr., 11/11)

Stat: BioNTech's CEO Wants To Widen Covid-19 Vaccine Access On His Terms
Two years ago, Ugur Sahin was an under-the-radar but extremely determined scientist running a company called BioNTech, which was trying to generate interest in using mRNA technology to combat different illnesses. Since then, he partnered with Pfizer to develop a Covid-19 vaccine that this year is forecast to generate about $19 billion in revenue for the company, assuming 2.5 billion doses are shipped. The vaccine is an historic success story — scientifically, medically, and financially — for both companies. But there are also questions about the extent to which booster doses will — or should be — needed as well as criticism about ensuring global access to vaccines in order to eradicate the pandemic. We spoke this week with Sahin over coffee about these issues. (Silverman, 11/11)

The Wall Street Journal: AstraZeneca Plans To Start Selling Covid-19 Vaccines At Profit
AstraZeneca AZN -0.35% PLC said it would start pricing its Covid-19 vaccine to make it profitable, ending a period in which it had pledged to roll out the shots at cost during the pandemic. The Anglo-Swedish pharmaceuticals giant said it would shift away from a nonprofit approach to the vaccine starting in 2022, signing new contracts that will allow it to make money off the shot. The company expects some earnings contribution from new orders in the fourth quarter of this year. The company said the shot generated $1.05 billion in revenue in the third quarter. (Butini, 11/12)

An at-home covid test recalled —

CBS News: FDA Recalls 2.2 Million Ellume COVID-19 Home Tests Due To False Positives
The U.S. Food and Drug Administration announced the recall of 2.2 million home COVID-19 tests made by Ellume, the first company to get FDA approval for over-the-counter COVID tests, due to "higher-than-acceptable false positive test results." The recall is an expansion of last month's recall of 200,000 kits for the same issue. About 35 false positives through the Ellume COVID-19 Home Test were reported to the FDA, with no deaths reported, the agency said. But false positives could lead to negative outcomes such as getting unneeded COVID-19 treatment from a health care provider or a delayed diagnosis for the person's actual illness, the FDA added. (Picchi, 11/11)

The Wall Street Journal: Ellume Recalls More Than 2 Million At-Home Covid-19 Tests Over False Positives
The Food and Drug Administration said more than 2 million at-home Covid-19 tests from Australia-based Ellume USA LLC have been recalled because of a number of false-positive results. The federal agency categorized the recall as a Class I, its most serious classification. It said false-positive test results could lead to serious health issues including unnecessary treatments and isolation, delayed treatments of the actual illness and spread of Covid-19 if those who received false-positive results are clustered with those who accurately tested positive. (Calfas, 11/11)

On antivirals and other covid drugs —

AP: EU Authorizes 2 Medicines For People At Risk Of Severe COVID
The European Medicines Agency has recommended the authorization of two new medicines against the coronavirus for people at risk of severe disease. In a statement on Thursday, the EU drug regulator said it had concluded that the monoclonal antibody treatments — a combination of casirivimab and imdevimab, and the drug regdanvimab — have both been proven to significantly reduce the risk of hospitalization and death in patients vulnerable to serious COVID-19. The EMA described the safety profile of both medicines as “favorable,” and said that despite a small number of side effects, “the medicines’ benefits are greater than their risks.” (11/11)

NBC News: How Covid Antiviral Pills Work and What That Could Mean for the Pandemic
Covid-19 may soon be treatable with a pill. In the past six weeks, two drugmakers have announced promising clinical trial results for their experimental oral antiviral pills and will soon have their data evaluated by the Food and Drug Administration. (Hickok, 11/12)

On India's vaccine —

Bloomberg: India’s Covaxin Found 77.8% Effective In Lancet Covid Study
Covaxin, a vaccine developed by India’s medical research agency and Bharat Biotech International Ltd., was 77.8% effective at preventing symptomatic Covid-19 in an interim analysis of a long-awaited study. Covaxin, which uses traditional, inactivated-virus technology, induced a robust antibody response two weeks after the second dose was given, the investigators concluded. No severe adverse events or vaccine-related deaths occurred during the randomized trial involving 24,419 adults. The research, conducted between November 2020 and May 2021 in India, was published in The Lancet. (Kay, 11/11)

Meanwhile —

CBS News: Why Aren't More Pregnant Women Of Color Getting Vaccinated Against COVID-19? Doctors Point To Distrust And Poor Outreach.
Maria del Carmen Garcia didn't have to look far for medical advice as she considered whether to get vaccinated against COVID-19. The 39-year-old teacher from Fort Hood, Texas, who at the time was trying to have another baby, consulted her sisters who work in health care and her husband who is a former pharmacy technician. "We do a lot of research in this house," she said. "Sometimes people look at us, they say, 'You guys read too much' — but we'd rather be overly informed than not." (Bayer, 11/11)

Dallas Morning News: Texas Republican State Sen. Bob Hall Says People Should Avoid The COVID-19 Vaccine
Republican state Sen. Bob Hall on Wednesday continued his broadsides against COVID-19 vaccines in a Facebook video viewed by more than 2,000 in which he told viewers to avoid the vaccine and echoed inaccurate claims that the vaccine is doing more harm than good. Hall has been careful to state that he is not against people getting the vaccine, but began his video with the unfounded and inaccurate “punchline” that COVID-19 vaccines are “killing more people than they are saving.” (Janowski, 11/11)