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BREAKING: Biden administration calls for waiving IP protections for COVID-19 vaccines

U.S. Trade Representative Katherine Tai announced on Twitter that the Biden administration supports a COVID-19 vaccine IP waiver.

Stocks of major COVID-19 vaccine makers Moderna and Pfizer are down today after U.S. Trade Representative Katherine Tai announced that the Biden administration supports waiving IP protections for COVID-19 vaccines.

“This is a global health crisis, and the extraordinary circumstances of the COVID-19 pandemic call for extraordinary measures,” Tai said in the statement.

Tai said the U.S. will actively participate in World Trade Organization text-based negotiations to make the IP protections waiver happen, though she added that such discussions will take time given the complexity of the WTO.

Moderna (Nasdaq:MRNA) shares are down more than –6% to $162.76 apiece, and Pfizer shares are down more than –1% to $39.53 apiece on the news this afternoon.

Even a…

U.S. to donate 60M doses of AstraZeneca’s COVID-19 vaccine

The Biden administration announced today that it will begin sharing its store of AstraZeneca’s COVID-19 vaccine following safety reviews.

Once the vaccine clears federal safety reviews, 60 million doses of the vaccine are expected to be made available, according to a Tweet from senior White House advisor Andy Slavitt.

“BREAKING: U.S. to release 60 million Astra Zeneca doses to other countries as they become available,” Slavitt wrote on the social media platform.

Get the full story at our sister site, Pharmaceutical Processing World.

U.S. to donate 60M doses of AstraZeneca’s COVID-19 vaccine

The Biden administration announced today that it will begin sharing its store of AstraZeneca’s COVID-19 vaccine following safety reviews.

Once the vaccine clears federal safety reviews, 60 million doses of the vaccine are expected to be made available, according to a Tweet from senior White House advisor Andy Slavitt.

“BREAKING: U.S. to release 60 million Astra Zeneca doses to other countries as they become available,” Slavitt wrote on the social media platform.

He followed the initial announcement with a reply, saying “to everyone who understandably says: ‘about time’ or ‘what were they waiting for’, at this time there are still very few available. No real time has been lost.”

The Associated Press, which was first to report the news, said the decision expands upon Biden’s earlier promise to share 4 million doses of the vaccine with Mexico and Canada.

According to the AP report, th…

MedTech 100 roundup: Small dip keeps industry down

The last month brought a bit of a skid for the medtech industry and after a slight rebound last week, the downward trend has returned.

A strong start to 2021 came to an end in late February and carried over into March, with MassDevice‘s MedTech 100 index hitting its lowest point on March 8 (102.16). It had only notched an all-time best of 110.96 on Feb. 15, leading to a fall at a level not seen since October.

While February’s highs have not yet been returned to, the industry showed signs of bouncing back last week (March 12) by finishing at 104.62.

Despite ticking up as high as 105.71 on Monday, March 15, the index regressed to the mark set the week prior, then dipped even further to end the week, coming in at 104.05 on March 19, marking a -0.5% drop week-over-week.

However, the industry remains in a better spot than it was at this time a year ago, as the index is now 12.7% up on the pre-COVID-19 pandemic high of 92.32 set on Feb. 19, 2020.<…

Xavier Becerra confirmed as HHS secretary

Image from Gage Skidmore on Flickr

The U.S. Senate narrowly voted to confirm Xavier Becerra as the secretary of the U.S. Dept. of Health & Human Services (HHS) today.

Becerra received the nomination for the position from President Joe Biden in December 2020. Today, the Senate voted 50-49 in favor of Becerra, who will have to resign his seat as the attorney general of California. He will succeed Alex Azar, who held the position during the Trump administration until his resignation just days before Biden’s inauguration.

Get the full story at our sister site, Medical Design & Outsourcing.

Xavier Becerra confirmed as HHS secretary

Image from Gage Skidmore on Flickr

The U.S. Senate narrowly voted to confirm Xavier Becerra as the secretary of the U.S. Dept. of Health & Human Services (HHS) today.

Becerra received the nomination for the position from President Joe Biden in December 2020. Today, the Senate voted 50-49 in favor of Becerra, who will have to resign his seat as the attorney general of California. He will succeed Alex Azar, who held the position during the Trump administration until his resignation just days before Biden’s inauguration.

Democrats unanimously backed his nomination in the Senate, while Republican senators were nearly united in opposing his confirmation, claiming Becerra’s past, which included Democratic legal challenges to policies from the Donald Trump administration, made him unfit for the position.

Becerra, a 12-term veteran of U.S. Congress, had previously advocated for healthc…

Biden to put $12B toward COVID testing

(Image courtesy of the White House)

The Biden administration today pledged $10 billion for school COVID-19 screenings and $2.25 billion for screenings and diagnostic testing among underserved populations.

The money is part of the $1.9 trillion American Rescue Plan Act that Biden signed into law last week.

The Department of Health and Human Services will divvy up the $10 billion among the states to fund screening tests of teachers, staff and students to help schools to reopen safely for in-person instruction. Screening tests are used to test asymptomatic people for COVID-19. The money will be deployed quickly to help schools reopen for the remainder of this year, according to an HHS news release.

Get the full story on our sister site, Medical Design & Outsourcing.

AdvaMed brass on Biden administration: So far, so good

In office barely two months, the Biden administration is winning high praise from leaders of the medtech trade group AdvaMed.

That applies to the new administration’s use of the Defense Production Act for COVID supplies to its deliberation in choosing someone to lead the FDA. It doesn’t hurt that the $1.9 trillion pandemic relief bill that President Biden signed into law today includes $500 million in general-purpose funding for the FDA. How much of that might be directed to the Center for Devices and Radiological Health, which regulates medical devices, remains to be seen.

Get the full story on our sister site, Medical Design & Outsourcing.

Amid controversy, Biden cancels Emergent Biosolutions visit

Image from René DeAnda on Unsplash

The White House scrapped plans to hold a Wednesday meeting at a Baltimore-based vaccine plant from Emergent BioSolutions following an exposé from The New York Times.

The Biden administration also announced plans to conduct an audit of the Strategic National Stockpile after the publication of the article, which described how the biopharmaceutical company lobbied the federal government to buy millions of anthrax vaccine doses.

Over the past ten years, the U.S. government has devoted almost half of its stockpile budget to BioSolutions’ anthrax vaccine, leaving a dearth of funding for pandemic response.

Get the full story from our sister site, Pharmaceutical Processing World.

COVID-19 vaccine hesitancy reducing, but challenges remain

Image courtesy of Pexels

The likely timeline for vaccinating a large share of the U.S. public has tightened recently. On Tuesday, President Biden promised enough COVID-19 vaccine would be available for all Americans by the end of May.

But while increases in vaccine production can address the current vaccine shortage, vaccine hesitancy will likely curb vaccination efforts in the coming months, according to Philipp Rosenbaum, a senior healthcare analyst at GlobalData. “With increases in vaccine production from Pfizer/BioNTech and Moderna, a newly authorized vaccine from Johnson and Johnson, and a manufacturing partnership between J&J and Merck & Co., confidence in reaching the goal is high.”

Indeed, the proportion of the public intending to receive the vaccine has increased from 60% to 69%, according to data from the Pew Research Center.

But many Americans don’t want the vaccine. Almost…

Report: Biden to announce partnership for Merck to make J&J’s COVID-19 vaccine

President Joe Biden is reportedly set to announce a partnership in which Merck (NYSE:MRK) will make Johnson & Johnson’s (NYSE:JNJ) recently approved COVID-19 vaccine.

The Washington Post reported that the agreement between the two competitors will boost the supply of the single-dose vaccine from J&J’s Janssen subsidiary, which received FDA emergency use authorization last week.

According to the report, anonymous officials told The Post that, upon the realization that J&J was behind on vaccine production in the early days of the Biden administration, they began looking for additional manufacturing capacity, landing on Merck as an option after the company was unable to produce its own COVID-19 vaccine.

Merck is set to provide two U.S. facilities for producing J&J vaccine doses, with one offering fill-finish services and the other actually making the vaccine. According to the report, this could potentially double the production capacit…

MedTech 100 roundup: Slight dip after all-time best for industry

The medtech industry’s stocks rose higher than they ever had to begin last week before eventually dropping to a slightly more normal level.

MassDevice‘s MedTech 100 index ended the week (Feb. 19) at 108.72 points, marking a -1.7% dip from the 110.63-point mark set at the end of the previous week (Feb. 12). On Monday (Feb. 15) the index hit its highest mark ever, though, rising to 110.96 points.

That mark sets an all-time best for the index, which has been on the rise for practically all of 2021 so far. It previously reached 106.81 points on Jan. 8, then 107.4 points on Jan. 20 before besting itself again with last week’s finish. The improvement has been considerably impressive given that the index had never reached even the 100-point mark before November 2020.

Medtech’s latest tally means the index has risen 17.8% from the pre-COVID-19 pandemic high of 92.32, set on Feb. 19, 2020. Additionally, the industry has very much rebounded from its lowest p…