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AstraZeneca missteps threaten to additional erode belief as firm seeks U.S. approval

AstraZeneca missteps threaten to further erode trust as company seeks U.S. approval

A medical syringe and vial in front of the logo of UK biopharmaceutical company AstraZeneca in this illustrative photo taken on November 18, 2020.

STR | NurPhoto | Getty Images

U.S. health officials released a bizarre statement early Tuesday that AstraZeneca may have based the results of its Covid-19 vaccine study on outdated information.

The company’s fumbling was just the latest “self-inflicted wound” in a series of missteps that threaten to undermine public confidence in his shot, public health and vaccine experts told CNBC.

On Monday, AstraZeneca announced the long-awaited results of its Phase 3 clinical trial of the Covid-19 vaccine it was developing at Oxford University. It is 79% effective in preventing symptomatic diseases and 100% effective against serious illness and hospitalization. According to the company, the analysis was based on 32,449 participants in 88 test centers in the USA, Peru and Chile.

Results questioned

The National Institute of Allergy and Infectious Diseases questioned the accuracy of these results early Tuesday when it was informed by the data and safety oversight body overseeing the study that the UK-based company may have information in the results of its U.S. Vaccine studies included that have provided an “incomplete view of efficacy data”.

“We urge the company to work with the DSMB to review efficacy data and ensure that the most accurate and up-to-date efficacy data is released as soon as possible,” said a NIAID statement.

NIAID director Dr. Anthony Fauci said the DSMB, an independent group of experts overseeing clinical trials in the United States, has raised concerns with the agency that the results in AstraZeneca’s press release are more favorable than more recent data from the vaccine study showed, according to STAT News. “I was kind of stunned,” Fauci told STAT, The agency could not be silent.

Unusual statement

The statement by NIAID, which is part of the National Institutes of Health, is highly unusual, health experts said. The last time a US agency statement caused a stir was in September when one of its panels said there was “insufficient data” to show convalescent plasma work against the coronavirus, in line with claims made at the time FDA Commissioner Dr. Stephen Hahn disagreed.

AstraZeneca’s data hiccup is just the latest example in a series of mistakes the company has made that could affect people’s willingness to take the vaccine, which may be approved as early as next month in the U.S., said Isaac Bogoch, an infectious disease expert sat on numerous data and security oversight bodies.

The problems first started in September after the company failed to promptly inform Food and Drug Administration officials that it called off its trial worldwide after a study participant fell ill, according to the New York Times. The company would face other issues later, including criticism, after volunteers were given incorrect vaccine doses in its studies and countries asked if its vaccine was suitable for use in people over 65. Most recently, countries suspended the use of the shot after reports of temporary blood clots in some vaccinated people.

Avoidable defects

“This has been an endless roller coaster ride of what I might call preventable communications mistakes,” Bogoch told CNBC. “You have to be open, you have to be honest, you have to be transparent. That includes both the good and the bad news.”

Bogoch said the missteps were not good for public confidence in the vaccine, adding: “We are already dealing with issues of public confidence in the launch of the vaccine [overall] and one must have public trust to have a successful public health initiative. “

Dr. Leana Wen, professor of public health at George Washington University and former Baltimore health commissioner, said AstraZeneca’s recent hiccups could damage not only public confidence in the company’s vaccine, but confidence in all of its Covid-19 vaccines .

“At this point it is really important that there is full transparency. We need to know what happened. Why does there seem to be this discrepancy in the data?” Said Wen. “I don’t remember seeing public disagreements like this one. And that is again throwing red flags at a time when we can least afford it.”

‘Be assured’

During an interview on CNN Tuesday, Andy Slavitt, President Joe Biden’s senior advisor on the pandemic, tried to reassure Americans about the vaccines. He said, “The public should be confident that nothing will be approved unless the FDA thoroughly analyzes it.” Data.”

When the AstraZeneca vaccine is reviewed by the FDA, the agency will “judge what the data says or what it says and whether or not it is approved. Until then, this is all just stuff that will do it.” happen in the background, “said Slavitt.” We believe this transparency and scientific independence are critical to public trust.

While Americans may not trust the vaccine, the data debacle is unlikely to affect the FDA’s review of the shot once the company submits it for emergency approval, said Lawrence Gostin, a law professor and director of the Collaborating Center on National and International the World Health Organization Global Health Act.

Pivot

“It certainly doesn’t help if the NIH rebukes you shortly before the application for approval,” Gostin said, adding that the number of “self-inflicted wounds” the company had “was astounding.” “AstraZeneca has a good and safe vaccine that I think will help vaccinate America and the world.”

Dr. William Schaffner, an epidemiologist who previously sat on two data security supervisory boards for staphylococcal vaccines, said the eventual FDA approval will be critical not only for the US but for other countries as well, as AstraZeneca’s vaccine is cheaper and easier to sell than its competitors.

“That would resonate around the world and give other health ministries confidence in this vaccine,” said Schaffner.

Correction: This story has been updated to correct the AstraZeneca vaccine dosing regimen. It requires two doses.

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Russia’s Sputnik vaccine will get its first approval within the EU, UAE

Russia’s Sputnik vaccine gets its first approval in the EU, UAE

A medical worker fills a syringe with the Gam-COVID-Vac vaccine (under the brand name Sputnik V) in Butovo, in southern Moscow.

Sergei Savostyanov | TASS | Getty Images

DUBAI, United Arab Emirates – Russian vaccine Sputnik V Covid-19 saw a number of improvements on Thursday as Hungary and the United Arab Emirates became the first countries in the European Union and the Gulf region to register the emergency shot.

Hungary’s decision was confirmed by President Viktor Orban’s spokesman, who said that if the country agrees to a shipping agreement with Moscow, it will be the first EU country to receive the vaccine. This is because the country’s cases have fallen from a high of more than 6,000 a day in early December to below 2,000 a day.

“This decision is very important as it shows that over 90% of the vaccine’s safety and efficacy is valued by our partners in Hungary,” said Kirill Dmitriev, head of the Russian Direct Investment Fund, in a statement.

The EU drug regulator has not yet approved the Russian stab, although Chancellor Angela Merkel gave Sputnik further hope on Thursday, suggesting that the German vaccine regulator could advise Russia on steering the EU approval process. The RDIF has submitted Sputnik for EU registration and expects its review in February.

UAE approval comes amid a dramatic surge in infections

The UAE approval comes amid a record spike in cases in the little Gulf Sheikh, which excelled internationally by welcoming tourists and fully reopening its economy by late summer last year.

Confirmed coronavirus cases have more than tripled in about three weeks, prompting Emirati authorities to suspend unnecessary hospital surgery and “entertainment” activities in their busy hotels and restaurants just days after the country gave assurances that the virus was under Control was to fail.

The UAE’s daily number of cases hit a record high of 3,529 on Thursday, well above neighboring Gulf states, where registered infections are below 500 per day.

A man from the Emirates wearing a protective mask walks at al-Barsha Health Center in the Gulf of Dubai on December 24, 2020.

GIUSEPPE CACACE | AFP via Getty Images

Sputnik V will be the third vaccine to be used in the United Arab Emirates after China’s Sinopharm vaccine and the Pfizer BioNTech vaccine developed in the US and Germany were released to the public in December. The country of around 10 million people is running the second fastest national vaccination campaign in the world after Israel per capita, according to the government, and aims to vaccinate half of the country’s population by the end of March.

“The decision is part of the UAE’s comprehensive and integrated efforts to ensure a higher level of prevention,” the country’s health ministry said in a statement on Thursday about Sputnik’s approval. “The study results have demonstrated the vaccine’s effectiveness in eliciting a strong antibody response to the virus, its safety to use and its compliance with international safety and efficacy standards.”

Lack of late-stage experimental data

The approvals came despite detailed research data not yet published on the results of the phase 3 human vaccine study. The capital of the United Arab Emirates, Abu Dhabi, began phase 3 testing for Sputnik V earlier this month but has not released any data on it. 1,000 volunteers in the emirate have received their first dose, according to RDIF.

Sputnik V, which according to its developer, the Gamaleya Research Institute, is 91% effective after two doses, has been used across Russia for months. Scientists expressed concern about what many have described as the rush to launch the vaccine, which gave the green light for mass use in Russia ahead of the completion of Phase 3 trials.

As the first step in the largest vaccination campaign in Argentina’s history, first line health workers are receiving the Russian Sputnik V vaccine against the coronavirus.

Patricio Murphy | SOPA pictures | LightRocket | Getty Images

Analysis of the phase 1 and phase 2 studies of the vaccine was published in The Lancet in September, which found that the initial results did not show any significant negative side effects, but further studies were required.

“The results of the Phase III clinical trials are expected to be published shortly,” according to the official Sputnik V.

Prior to Thursday’s announcements, it had been approved for emergencies in nine countries and territories outside Russia – Algeria, Argentina, Bolivia, Belarus, Serbia, Venezuela, Paraguay, Turkmenistan and the Palestinian Territories.

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Health

An 11th-Hour Approval for Main Modifications to Medicaid in Tennessee

An 11th-Hour Approval for Major Changes to Medicaid in Tennessee

12 days to go, the Trump administration approved a long-conservative goal on Friday: to issue a state’s Medicaid funding as a block grant with a spending cap.

The structural experiment in Tennessee, which would go into effect after legislative approval, would take 10 years. Block grants to Medicaid were a priority for Seema Verma, the administrator of the Centers for Medicare and Medicaid Services and a former advisor who helped states write exemption requests.

“We tried to get some of the successes that we thought were some of the positive things about block grants that people have been talking about for years,” Ms. Verma said. “And we tried to address some of the criticisms.”

Patient advocates in Tennessee, concerned that the new structure would result in poor people losing access to health care, are planning a lawsuit, and the Biden administration will almost certainly try to reverse this if they get the Department of Health and takes over human services.

But over the past week the Trump administration has tried to slow the reverse of its Medicaid experiments. Traditionally, such exemptions are agreements between HHS and states that can be severed with minimal effort. But Ms. Verma has sent letters to Medicaid state directors asking them “as soon as possible” to sign new contracts outlining more detailed procedures for terminating exemptions. Under the terms of the contract, the federal agency undertakes not to terminate a waiver with less than nine months’ notice.

“It’s so obvious,” said Joan Alker, executive director of the Georgetown Center for Children and Families. “She’s trying to handcuff the Biden administration.”

Ms Verma said the treaties are a way to ensure that exceptions are only revoked if they are harmful. “We want to make sure that people don’t get into office and end waivers on a political whim,” she said.

The waiver allows Tennessee, one of a dozen states that have not adopted the Medicaid extension under Obamacare, to abandon the normal structure of the Medicaid program. In this structure, the federal government lays down detailed rules about who must be covered and what services are offered to them in exchange for an indefinite obligation to pay part of the bills of Medicaid patients. Tennessee would be given new freedom to change what services its program covers, but its funding would be capped on a formula each year.

When Tennessee spends less than the block grant amount, 55 percent of the savings can be spent on a wide range of health-related services. If it spends more, the difference must be made up with government funds. The waiver places some restrictions on the aspects of the program that can be changed and would allow the spending cap to be increased as more people are enrolled with Medicaid, as would normally be the case in an economic downturn.

A key area of ​​flexibility in the exemption concerns prescription drugs. In general, Medicaid has to cover a wide variety of medications, but is guaranteed to pay the lowest price of any US buyer. Tennessee is allowed to renegotiate prices with drug companies and may decline drug coverage if it considers prices too high. Massachusetts filed a waiver requesting a similar agency without a broader block grant, and that was denied.

In Tennessee, doctors and hospital groups, among others, have criticized the proposal. “The vast majority of comments CMS received were against Tennessee’s proposed demonstration,” the approval document said.

Governor Bill Lee, a Republican, described the program as a “legacy achievement”.

“We have shown that partnership is a better model than dependency,” he told reporters.

Waiver statements were a core part of Ms. Verma’s tenure with the Medicaid agency. In addition to the Tennessee Block Grant Waiver, she has approved Medicaid’s work requirements for certain adults in 12 states. Federal courts have repeatedly repealed these exemptions, and few of them are in force.

Michele Johnson, executive director of the Tennessee Justice Center, a legal aid group that helps poor Tennesseans, said she was trying to encourage lawmakers to oppose the waiver. A block grant she has always turned down fits particularly well with a public health crisis where health spending could accelerate in unusual ways. “The only way this makes sense is for the Trump administration to burn everything down on the way to the door,” she said.

She also noted a history of challenges the state faced in running its more traditional Medicaid program. “It is hard to imagine that a state would be less suitable for a block grant than ours,” she said.

Sheryl Gay Stolberg contributed to the coverage.

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Health

FDA advisory panel meets at this time to vote on whether or not to advocate approval of Pfizer’s Covid vaccine

FDA advisory panel meets today to vote on whether to recommend approval of Pfizer's Covid vaccine

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A panel from the Food and Drug Administration will meet Thursday to vote on whether to recommend Pfizer and BioNTech’s emergency approval of the coronavirus vaccine.

Prior to voting by the Agency’s Advisory Committee on Vaccines and Related Biological Products, the independent panel of medical experts will evaluate the Pfizer clinical trial data and provide their opinion on the vaccine, including whether the benefits outweigh the risks in an emergency .

The FDA is not required to follow the advice of the advisory group, but it often does.

A recommendation from the advisory committee is the final step before the FDA is likely to give final OK to the distribution of the potentially life-saving doses in the United States. The vaccine would be the first to be approved for use in the United States

Read CNBC’s live updates for the latest news on the Covid-19 outbreak.