White House sounds alarm over Covid-19 vaccine and monoclonal supply shortages – Endpoints News


The White House warned Congress Tuesday afternoon: If you don’t authorize billions more dollars to fight Covid-19, the United States officially won’t have enough money for another injection of Covid-19. booster, if necessary, or more monoclonal antibodies and antivirals.

The call to break the funding stalemate comes as Congress moved to include about $15 billion — Biden initially wanted nearly $23 billion — in pandemic funds in a larger annual spending package this week. last. The move was made in part to expedite the larger spending bill and Ukrainian aid, and as Republicans have sought better accountability of where trillions in prior Covid funds have been spent.

Sen. Richard Burr (R-NC) told a hearing on Tuesday that he understands the need for additional Covid funding, “but we need more information on the details of the oversight,” as the number of vaccines and treatments the United States has in its inventory. “These are reasonable requests that we need to make,” he said, noting that the administration had blocked those requests.

The White House, however, has stressed the need for more funding, especially now.

“First, on vaccines: Without additional funding, we don’t have the adequate resources to purchase enough boosters for all Americans if an additional vaccine is needed,” a senior Biden administration official told reporters during the briefing. a call today.

While noting that Covid-19 cases are down 95% since Omicron’s peak, the White House stressed that now is the time to refuel.

The senior official said the government previously planned to purchase additional monoclonal antibodies (GlaxoSmithKline and Eli Lilly still have effective ones) as early as next week.

“Without additional funding, we are canceling these plans,” the official said, noting that governors were scheduled to be told today that the number of monoclonal antibody treatments sent to states will be reduced by 30% from the week. next.

On the antiviral front, the Biden administration noted in a statement that because pills like Pfizer’s Paxlovid can take upwards of 6 months to manufacture, the United States will “probably not have enough of these treatments by then.” end of the year. And not being able to make additional purchasing commitments likely means fewer treatments will be available next year as well. »

Meanwhile, the Senate Health Committee passed its own far-reaching pandemic bill on Tuesday, advancing it on a 20-2 vote, without adding major changes.

The senses. Mike Braun (R-IN) and Rand Paul (R-KY) proposed an amendment that would have added a reciprocity provision to the FDA approval pathway where drugs approved elsewhere by stringent regulators could enter the market at United States unless the FDA says otherwise, and the FDA has 90 days to act before the approval automatically takes effect.

But Ranking Member Burr objected and said it would be “a huge mistake” to dictate what the FDA should do based on other countries.

Research published in the BMJ in 2017 noted how, from 2001 to 2010, 12 of 37 drugs with new mechanisms of action that were first approved in Europe and/or Canada (32%) saw their initial FDA applications rejected on safety grounds, including 2 drugs eventually withdrawn from the market in Europe due to safety concerns.

The Braun Amendment failed on a vote of 16-6.

But the far-reaching bill that aims to lay the groundwork for the next pandemic has come out of committee and contains some exciting new proposals for the FDA, but not the additional Covid-19 funds.

Committee chair Patty Murray (D-WA) outlined how the bipartisan bill will set up a thorough investigation into the federal government’s response to Covid-19, much like the 9/11 Commission. She also insisted on the need to push through the additional Covid funding, noting that “a fire is dangerous to the last ember”.

The text of the bill also includes some intriguing new FDA-related developments.

For example, the bill would create an “advanced platform technology designation” at the FDA, similar to breakthrough and orphan designations, which would expedite the development and review of new treatments using platform technologies and may be incorporated or used in more than one drug or biologic.

The bill would also expand eligibility for qualified product designation for infectious diseases to include biologics, and it seeks to harmonize the actions of the FDA and foreign drug regulatory authorities with respect to the use of digital health technologies, decentralized trials, continuous, concurrent and other trials. designs.

Additionally, the bill would codify the FDA’s Coronavirus Treatment Acceleration Program, which has accelerated access to new Covid treatments.

On the manufacturing front, the bill would require the FDA to conduct a pilot program to increase the number of unannounced inspections of foreign pharmaceutical facilities (which was a provision also included in the federal budget bill) and to publish a report to assess the differences between unannounced inspections. and announced inspections, barriers to conducting unannounced inspections, and challenges in leveling the playing field for domestic and foreign drug inspections.


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