Posts tagged with "Vaccines"

Biden to deliver six-step plan on COVID

September 10, 2021

On Thursday, September 9, President Joe Biden was expected to outline new approaches to control the COVID-19 pandemic in the United States, which rages on despite the wide availability of vaccines, reports Thomson Reuters Foundation News.

In his speech, Biden planned to focus on six areas—among them, new plans to get more people vaccinated, enhancing protection for those who already have had shots, and keeping schools open, according to a White House official.

In addition, the official said, the president would discuss increasing testing and mask-wearing, protecting an economic recovery from the pandemic-induced recession, and improving healthcare for people infected with the disease.

“We know that increasing vaccinations will stop the spread of the pandemic, will get the pandemic under control, will return people to normal life,” White House Press Secretary Jen Psaki told reporters on Wednesday. “We have more work to do, and we are still at war with the virus.”

Increasing infections have raised concerns as children head back to school, while also rattling investors and upending company return-to-office plans.

Just over 53% of Americans are fully vaccinated, including almost two-thirds of the adult population, according to CDC data. The disease has killed more than 649,000 Americans.

With many Americans still skeptical of the shots, the White House already has announced plans to give those who are fully vaccinated booster shots for more additional protection.

In doing so, they have rejected arguments from the World Health Organization and other advocates that rich countries should hold off on booster shots before more people worldwide have been inoculated.

Research contact: @thomsonreuters

Taking ‘extraordinary measures,’ White House backs suspending patents on vaccines

May 7, 2021

The Biden Administration came out on Wednesday, May5, in support of waiving intellectual property protections for coronavirus vaccines—thereby, siding with international efforts to bolster production amid concerns about vaccine access in developing nations, The New York Times reports.

Under former President Trump, the United States had been a major holdout at the World Trade Organization over a proposal to suspend some of the world economic body’s intellectual property protections—enabling drugmakers worldwide to gain access to the closely guarded trade secrets of how the vaccines have been made.

However, the Times notes, President Biden had come under increasing pressure to throw his support behind the proposal, drafted by India and South Africa and backed by many congressional Democrats.

Katherine Tai, the United States Trade Representative, announced the Administration’s position on Wednesday afternoon, as the pandemic continued to spiral in India and South America.

“This is a global health crisis, and the extraordinary circumstances of the COVID-19 pandemic call for extraordinary measures,” Tai said in a statement. “The Administration believes strongly in intellectual property protections, but in service of ending this pandemic, supports the waiver of those protections for COVID-19 vaccines.”

Support from the White House is not a guarantee that a waiver will be adopted. The European Union has also been standing in the way, and changes to international intellectual property rules require unanimous agreement. Tai said the United States would participate in negotiations at the World Trade Organization over the matter, but that they would “take time given the consensus-based nature of the institution and the complexity of the issues involved.”

Standing against her will be the pharmaceutical industry, which responded angrily to the extraordinary decision. Stephen J. Ubl, the president and CEO of the Pharmaceutical Research and Manufacturers of America (PhRMA), called the announcement “an unprecedented step that will undermine our global response to the pandemic and compromise safety.”

“This decision will sow confusion between public and private partners, further weaken already strained supply chains and foster the proliferation of counterfeit vaccines,” he said in a statement, adding that the move would have the effect of “handing over American innovations to countries looking to undermine our leadership in biomedical discovery.”

The pharmaceutical industry has argued that a suspension of patent protections would undermine risk-taking and innovation.

“Who will make the vaccine next time?” Brent Saunders, the former chief executive of Allergan, which is now part of AbbVie, wrote on Twitter.

However, the Times reports, global health activists, who have been pressing for the waiver, praised the Administration’s decision. It is “a truly historic step, which shows that President Biden is committed to being not just an American leader, but a global one,” said Priti Krishtel, an executive director of the Initiative for Medicines, Access & Knowledge (I-MAK).

But the activists said a waiver alone would not increase the world’s vaccine supply. It must be accompanied by a process known as “tech transfer,” in which patent holders supply technical know-how and personnel. Activists also are demanding that Biden use his leverage to ensure that manufacturing is scaled up around the globe, and not just by the pharmaceutical companies that now hold the patents.

“Handing needy countries a recipe book without the ingredients, safeguards and sizable work force needed will not help people waiting for the vaccine,” Dr. Michelle McMurry-Heath, the president and chief executive of the Biotechnology Innovation Organization (BIO), said in a statement. “Handing them the blueprint to construct a kitchen that — in optimal conditions — can take a year to build will not help us stop the emergence of dangerous new Covid variants.”

Shares of the pharmaceutical companies BioNTech, Moderna and Novavax dropped on Wednesday afternoon as news broke of the Biden administration’s decision.

Research contact: @nytimes

Moderna’s vaccine is highly effective, FDA says, clearing way for second vaccine

December 16, 2020

Moderna’s COVID-19 vaccine is 94% effective at preventing symptomatic illness—and appears to prevent the spread of the virus, as well—according to an FDA briefing document released on Tuesday, December 15, NBC News reports. .

The findings set the Moderna vaccine up for emergency use authorization by the FDA—which would double the number of COVID-19 vaccines available, after the first shots of Pfizer-BioNTech’s vaccine were given to healthcare workers nationwide in the USA on Monday.

The high efficacy of the Moderna vaccine was achieved after two doses given 28 days apart. This is about the same level of effectiveness as the Pfizer-BioNTech vaccine.E

But there is also evidence that just one dose of Moderna’s may stop the virus’s spread. A second document published on the FDA website shows asymptomatic infection was reduced by 63% after the first shot.

Still, it is expected that regulators will require two doses of the vaccine for maximum protection, NBC News notes.

A committee independent of the FDA, the Vaccines and Related Biological Products Advisory Committee, will meet Thursday to decide whether to recommend that the agency greenlight the Moderna vaccine. The meeting will largely mirror the one from last Thursday, when the panel of experts ultimately recommended that the FDA authorize Pfizer’s vaccine.

The vaccines from both drugmakers use similar technology.

It is widely anticipated that the Moderna vaccine’s path to approval will be similar to Pfizer’s. Indeed, NBC reports, an authorization could come as soon as Friday. And officials with Operation Warp Speed are already planning for widespread distribution of the Moderna vaccine.

Research contact: @NBCNews