FDA revokes emergency use authorization for monoclonal antibody bamlanivimab

‘Today, the U.S. Food and Drug Administration revoked the emergency use authorization (EUA) that allowed for the investigational monoclonal antibody therapy bamlanivimab, when administered alone, to be used for the treatment of mild-to-moderate COVID-19 in adults and certain pediatric patients. Based on its ongoing analysis of emerging scientific data, specifically the sustained increase of SARS-CoV-2 viral variants that are resistant to bamlanivimab alone resulting in the increased risk for treatment failure, the FDA has determined that the known and potential benefits of bamlanivimab, when administered alone, no longer outweigh the known and potential risks for its authorized use. Therefore, the agency determined that the criteria for issuance of an authorization are no longer met and has revoked the EUA.’

Read here (US FDA, Apr 16, 2021)

The antibody deception

‘Virtually every study and piece of marketing material related to Covid is premised on scientists having positively and correctly identified the presence of the novel coronavirus (also known as SARS-CoV-2) in the material they’re working with.

‘The job of that identification is usually given to antibodies that are said to bind to the novel coronavirus. The assumption is these antibodies are able to pick out the virus and only the virus from among every other organism and substance surrounding it.

‘Unfortunately it turns out that the antibodies rarely (if ever) do that. This is because of, among other things, inadequate verification of the antibodies’ accuracy in targeting the virus by the companies that manufacture and sell them. And there’s even less verification by government regulators.’

Read here (OffGuardian, Mar 6, 2021)

The vaccine alternatives for people with compromised immune systems

‘While the exact number of the immunocompromised worldwide is unknown, estimates suggest that about 10 million live in the U.S. alone, or around 3 percent of the national population. The number encompasses a diverse range of vulnerabilities, including rare genetic immune deficiencies, chronic illnesses that impair the immune system such as rheumatoid arthritis, and cancer and organ-transplant patients who must take immune-suppressing medications.

‘For them, vaccines will not be effective, because they are incapable of making their own antibodies to neutralize the SARS-CoV-2 virus. Instead, pharmaceutical companies around the world are racing to develop alternative treatments that bypass the immune system altogether.

‘The most common option is called monoclonal antibody treatments. These artificially generated antibodies mimic the body’s natural immune response by binding to key sites on the virus’ spike protein, preventing it entering cells and reproducing. Companies including AstraZeneca, Regeneron, and Eli Lilly are currently testing whether monoclonal antibodies can protect immunocompromised people from SARS-CoV-2.’

Read here (National Geographic, Feb 4, 2021)

Coronavirus antibody therapies explained

How do bamlanivimab and REGN-CoV-2 work?: ‘Both antibody treatments are designed to block the SARS-CoV-2 spike protein and thus prevent the virus from attaching to and entering human cells. These identical so-called monoclonal antibodies are lab-engineered and designed to attack one specific virus in one distinct way.

‘Bamlanivimab contains one monoclonal antibody. REGN-CoV-2, in contrast, consists of two monoclonal antibodies. US pharma company Regeneron says its antibody cocktail lowers the viral load, which helps symptoms dissipate more quickly.

‘The advantage of Regeneron's drug cocktail is that by containing two antibodies, it increases the chance that at least one of them will prove effective during treatment, virologist Sandra Ciesek told German public broadcaster NDR.’

Read here (DW, Jan 29, 2021)

Eli Lilly says its monoclonal antibody, bamlanivimab, prevented Covid-19 infections in clinical trial

‘Eli Lilly said Thursday that its monoclonal antibody prevented Covid-19 infections in nursing home residents and staff in a clinical trial, the first time such a treatment has been shown to prevent infection. Lilly released the results in a press release, although it said that it would publish the data in a research paper as quickly as possible.

‘In November, the antibody, bamlanivimab, was authorized for emergency use by the Food and Drug Administration in treating patients with Covid who are at risk of more severe disease. An antibody cocktail made by the biotechnology firm Regeneron has also been authorized... But Lilly believes its antibody could be an option not just to treat Covid-19 but to help prevent it in limited circumstances.’

Read here (STAT News, Jan 21, 2021)

Covid-19 vaccine developers ask the SEC to help keep the secret of how they set prices

‘When the U.S. government awarded over $10 billion in contracts and advance- purchase commitments to drug companies working on COVID-19 vaccine and treatments, it did not require the recipients of government money to agree to offer their products at fair prices or share intellectual property rights to enable faster production.

‘Now, two of the companies awarded those contracts—Pfizer and Johnson & Johnson—are trying to prevent shareholders from voting on resolutions to require the companies to disclose information about the impact of government funding on vaccine access...

‘The shareholder resolutions, filed by members of the Interfaith Center on Corporate Responsibility (ICCR), a shareholder activism organization, ask those two companies to inform their shareholders how "receipt of public financial support for development and manufacture of products for COVID-19 is being, or will be, taken into account when making decisions that affect access to such products, such as setting prices." Similar resolutions were also filed at Eli Lilly, Gilead, Merck, and Regeneron.

‘Both Pfizer and Johnson & Johnson filed "no action requests" with the Securities and Exchange Commission (SEC) in December, asking the agency to rule that the companies can withhold the proposals from shareholders. Neither company responded to The Daily Poster requests for comment.’

Read here (Newsweek, Jan 2, 2021)