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...the U.S. Food and Drug Administration authorized the first serology test that detects neutralizing antibodies from recent or prior SARS-CoV-2 infection, which are antibodies that bind to a specific part of a pathogen and have been observed in a laboratory setting to decrease SARS-CoV-2 viral infection of cells. The FDA issued an emergency use authorization for the cPass SARS-CoV-2 Neutralization Antibody Detection Kit, which specifically detects this type of antibody...Although the FDA has previously issued EUAs to more than 50 antibody tests, those tests only detect the presence of binding antibodies. Binding antibodies bind to a pathogen, such as a virus, but do not necessarily decrease the infection and destruction of cells...READ MORE

Following a rapid course of development and testing, Gilead Sciences Inc. has secured the first and only FDA approval for a COVID-19 treatment, the antiviral Veklury (remdesivir). Previously authorized only for emergency use (EUA) in the U.S., the drug can now be prescribed to adults and children 12 and older weighing at least 40 kg for the treatment of COVID-19 requiring hospitalization...READ MORE

U.S. President Donald Trump said...he may or may not approve any new, more stringent FDA standards for an emergency authorization of a COVID-19 vaccine, saying such a proposal would appear political...The Washington Post reported on Tuesday the U.S. Food and Drug Administration would issue the guidance to boost transparency and public trust as health experts have become increasingly concerned the Trump administration might be interfering in the approval process to rush out a vaccine...READ MORE

Several COVID-19 vaccine developers, including Pfizer Inc, Johnson & Johnson and Moderna Inc, plan to issue a public pledge not to seek government approval until their vaccine candidates are proven to be safe and effective...The companies would pledge to adhere to high scientific and ethical standards in the conduct of clinical studies and in their manufacturing processes, the Journal report here said, citing the draft of a joint statement that is still being finalized...The news comes amid rising concerns that political pressure ahead of the Nov. 3 election could weigh on the safety and effectiveness of a potential vaccine for the respiratory illness...READ MORE

Washington, Oregon and Nevada will join California to independently review any coronavirus vaccine before distributing it to the public...Gov. Gavin Newsom said Tuesday that the three states would identify their own public health experts to participate in the scientific review committee he announced last week, which was charged with ensuring that any vaccine approved by the U.S. Food and Drug Administration is safe and effective...California has also formed a second committee to develop guidelines for the ethical distribution of vaccines, Newsom said, addressing questions about who should receive the first doses and how to allocate potentially limited supplies...READ MORE

A California panel of experts will independently review the safety of new coronavirus vaccines and initial plans for distribution, Governor Gavin Newsom said...The 11-person panel specializing in topics such as epidemiology, biostatistics, and infectious disease will review any vaccine approved by the Food and Drug Administration before it is distributed to state residents, Newsom told a news conference...The U.S. government’s efforts to speed development of a COVID-19 vaccine - and promises by U.S. President Donald Trump that one could be available prior to the Nov. 3 presidential election - has led to concerns of political interference in the regulatory process at the expense of safety. The FDA has vowed to ensure the safety of COVID-19 vaccines before approving them...READ MORE

The US Food and Drug Administration... is expected to issue new, tougher requirements for its approval of a coronavirus vaccine, a move that could obliterate the chances of a shot getting emergency use authorization before Election Day...Regulators could publish the new approval standards as early as this week, and will do so publicly in an effort to bolster Americans' eroded trust in the US to ensure the safety a COVID-19 vaccine...President Trump and his Operation Warp Speed initiative have been pushing for months to have a coronavirus vaccine approved ahead of the November 3...READ MORE

As the leading COVID-19 vaccines move closer to potential emergency use, the research and regulatory processes have been intensely scrutinized. But there’s one area that hasn’t seen as much attention so far—manufacturing facility inspections...COVID-19 vaccine developers seeking FDA emergency use authorizations won’t have to undergo pre-approval site inspections...The FDA conducts thousands of facility inspections per year, and some find flaws that drug or vaccine companies must remedy before launching new products...READ MORE

Food and Drug Administration advisory committee meetings tend to be staid, albeit important, events typically watched by a few dozen company representatives, scientists, investors and patient advocates...But next week's hearing on coronavirus vaccine studies will be set against the backdrop of a presidential election 12 days later that could turn on the White House's response to the pandemic, likely making it a closely-watched affair of historic proportions...In the meantime, here are five important questions that could feature at next week's meeting...READ MORE

• How will vaccine safety be monitored following an emergency clearance? After a full approval?
• How long will immunity last and how would it be measured?
• How will vaccine-induced enhanced respiratory disease be monitored?
• Has enough data been collected on vulnerable groups?
• Will future vaccine trials need to measure COVID-19 cases, or will immune response data be enough?

Safe and effective vaccines represent the most effective way to restore the health and economic security disrupted by the Covid-19 pandemic. To help achieve that goal, the U.S. government launched Operation Warp Speed...to accelerate development and manufacturing of several Covid-19 vaccines, with a goal of having 300 million doses available to the U.S. population by January 2021...Operation Warp Speed is expediting vaccine development primarily by moving clinical trials forward without pauses between phases, and by scaling up manufacturing capacity before knowing if a candidate works...Covid-19 vaccines can help stop the pandemic only if people trust them and want to be vaccinated. To earn and keep the trust of the American people, our government needs to ensure three key needs are met before launching any immunization campaign...READ MORE

• Ensure transparency and confidence in FDA decisions
• Ensure robust active safety monitoring as Covid-19 vaccines are rolled out
• Ensure the distribution and administration of Covid-19 vaccines are equitable and well-executed