As in 55 years beyond.

That’s how long the Food & Drug Administration in court papers this week proposes it should be given to review and release the trove of vaccine-related documents responsive to the request. If a federal judge in Texas agrees, plaintiffs Public Health and Medical Professionals for Transparency can expect to see the full record in 2076.

The 1967 FOIA law requires federal agencies to respond to information requests within 20 business days. However, the time it takes to actually get the documents “will vary depending on the complexity of the request and any backlog of requests already pending at the agency,” according to the government’s central FOIA website.

Justice Department lawyers representing the FDA note in court papers that the plaintiffs are seeking a huge amount of vaccine-related material – about 329,000 pages.

The plaintiffs, a group of more than 30 professors and scientists from universities including Yale, Harvard, UCLA and Brown, filed suit in September in U.S. District Court for the Northern District of Texas, seeking expedited access to the records. They say that releasing the information could help reassure vaccine skeptics that the shot is indeed “safe and effective and, thus, increase confidence in the Pfizer vaccine.”

But the FDA can’t simply turn the documents over wholesale. The records must be reviewed to redact “confidential business and trade secret information of Pfizer or BioNTech and personal privacy information of patients who participated in clinical trials,” wrote DOJ lawyers in a joint status report filed Monday.

The FDA proposes releasing 500 pages per month on a rolling basis, noting that the branch that would handle the review has only 10 employees and is currently processing about 400 other FOIA requests.

“By processing and making interim responses based on 500-page increments, FDA will be able to provide more pages to more requesters, thus avoiding a system where a few large requests monopolize finite processing resources and where fewer requesters’ requests are being fulfilled,” DOJ lawyers wrote, pointing to other court decisions where the 500-page-per-month schedule was upheld.

Civil division trial lawyer Courtney Enlow referred my request for further comment to the DOJ public affairs office, which did not respond.

Plaintiffs’ lawyers argue that their request should be top priority, and that the FDA should release all the material no later than March 3, 2022.

“This 108-day period is the same amount of time it took the FDA to review the responsive documents for the far more intricate task of licensing Pfizer’s COVID-19 vaccine,” wrote Aaron Siri of Siri & Glimstad in New York and John Howie of Howie Law in Dallas in court papers.

“The entire purpose of the FOIA is to assure government transparency,” they continued. “It is difficult to imagine a greater need for transparency than immediate disclosure of the documents relied upon by the FDA to license a product that is now being mandated to over 100 million Americans under penalty of losing their careers, their income, their military service status, and far worse.”

They also argue that Title 21, subchapter F of the FDA’s own regulations stipulates that the agency “is to make ‘immediately available’ all documents underlying licensure of a vaccine.”

Given the intense public interest in the vaccine, the plaintiffs’ lawyers say that the FDA “should have been preparing to release (the data) simultaneously with the licensure. Instead, it has done the opposite.”

Siri declined comment.

To meet the plaintiffs’ proposed FOIA deadline, the FDA would have to process a daunting 80,000 pages a month. But the plaintiffs note that the FDA has 18,000 employees and a budget of $6 billion and “has itself said that there is nothing more important than the licensure of this vaccine and being transparent about this vaccine.”

To be sure, most people — including many who sanctimoniously proclaim “I do my own research” — lack the expertise to evaluate the information.

But the plaintiffs, who also include overseas professors from the UK, Germany, Denmark, Australia and Canada, appear to be well-positioned to do so.

As Siri and Howe argue, “Reviewing this information will settle the ongoing public debate regarding the adequacy of the FDA’s review process.”

U.S. District Judge Mark Pittman has set a scheduling conference for December 14 in Fort Worth to consider the timeline for processing the documents.

Opinions expressed here are those of the author. Reuters News, under the Trust Principles, is committed to integrity, independence and freedom from bias.

Our Standards: The Thomson Reuters Trust Principles.

Jenna Greene
Jenna Greene writes about legal business and culture, taking a broad look at trends in the profession, faces behind the cases, and quirky courtroom dramas. A longtime chronicler of the legal industry and high-profile litigation, she lives in Northern California. Reach Greene at jenna.greene@thomsonreuters.com

Source: https://www.reuters.com/legal/government/wait-what-fda-wants-55-years-process-foia-request-over-vaccine-data-2021-11-18/

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The Food and Drug Administration on Friday approved requests by COVID-19 vaccine makers Moderna and Pfizer to expand the administration of their booster shots to all U.S. adults.

In a release announcing the news, biotechnology company Moderna said the FDA extended the emergency use authorization of a booster dose of the Moderna COVID-19 vaccine at the 50 µg dose level to all adults aged 18 and older.

The booster can be used in all individuals 18 years and older who have completed a primary vaccination with any other authorized or approved COVID-19 vaccine.

“This emergency use authorization comes at a critical time as we enter the winter months and face increasing COVID-19 case counts and hospitalizations across the country,” Moderna CEO Stéphane Bancel said in a statement. “We thank the FDA for their review, and are confident in the robust clinical evidence that a 50 µg booster dose of mRNA-1273 induces a strong immune response against COVID-19.”

Pfizer, which partnered with BioNTech on the vaccine, said its booster dose is to be administered at least six months after completion of the primary series and is the same dosage strength as the doses in the primary series.

“With boosters, more adults will now have the opportunity to help preserve a high-level of protection against this disease,” Pfizer CEO Albert Bourla said in a statement. “We are grateful to the FDA for their rigorous review, and the action taken today that we hope will help accelerate our path out of this pandemic.”

“Today’s FDA decision is supported by clinical data showing robust immune responses following a booster dose of our vaccine, exceeding what has been seen even after the completion of the highly-effective two-dose primary schedule,” BioNTech CEO Ugur Sahin said. “These data suggest a booster dose of our vaccine has the potential to maintain a high-level of protection against tested variants, including Delta.”

Later Friday, the U.S. Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) will meet to discuss a potential recommendation for the rollout of COVID-19 boosters to the U.S.

CDC data shows that more than 32 million Americans have already received a booster dose.

Source: https://www.foxbusiness.com/lifestyle/moderna-pfizer-covid-boosters-approved

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(AMSTERDAM) — The European Union on Monday gave official approval for the coronavirus vaccine developed by BioNTech and Pfizer to be used across the 27-nation bloc, raising hopes that countries can begin administering the first shots to their citizens shortly after Christmas.

The EU’s executive commission gave the green light just hours after the European Medicines Agency said the vaccine meets safety and quality standards. Brussels had been expected to take two or three days to endorse the market authorization move.

“As we have promised, this vaccine will be available for all EU countries at the same time, on the same conditions,” said European Commission President Ursula von der Leyen. “This is a very good way to end this difficult year, and to finally start turning the page on COVID-19.”

Deliveries of the vaccine had been penciled in to start this coming Saturday, with inoculations beginning across the EU between Dec. 27-29, she said.

The same vaccine was authorized in Britain and the United States weeks ago, prompting pressure from EU governments for EMA to speed up its approval process as virus cases surged again across the continent.

EMA originally set Dec. 29 as the date for evaluating the vaccine but moved up the meeting to Monday after calls from the German government and others for the agency to move more quickly.

Harald Enzmann, the head of EMA’s expert committee, dismissed any suggestion that political influence had affected the decision.

“The focus was exclusively on the science,” he told reporters. “That was a scientific assessment, full stop.”

The Amsterdam-based EMA is responsible for approving all new drugs and vaccines across the 27 EU member states, Iceland, Liechtenstein, and Norway. It is roughly equivalent to the U.S. Food and Drug Administration.

The vaccine has already been given some form of regulatory authorization in at least 15 countries.

Britain, Canada, and the U.S. authorized the vaccine to be used according to emergency provisions, meaning the shot is an unlicensed product whose temporary use is justified by the pandemic that has killed almost 1.7 million people worldwide, according to a tally by Johns Hopkins University.

Switzerland became the first country Saturday to authorize the vaccine according to the normal licensing procedure. EMA’s conditional market authorization also followed the regular process, only on an accelerated schedule and under the condition that the pharmaceutical companies submit follow-up data on their vaccine for the next year.

While many have clamored for the vaccine’s authorization, there have also been concerns, in Europe and elsewhere, about the speed with which the shot was developed. Normally, vaccines take years to develop and approve, not months.

In a statement last week that appeared to address those concerns, the agency stressed that the vaccine would only be approved after a scientific assessment showed its overall benefits outweighed the risks.

Scientists are still waiting for more long-term follow-up data to see how long immunity from the vaccine lasts and if there are any rare or serious side effects. Final testing of the vaccine is still ongoing, and more information on whether the shot works in children is needed. EMA experts also said that data on pregnant women is limited, and physicians should decide on a case-by-case basis.

The vaccine is not made with the coronavirus itself, meaning there’s no chance anyone could catch it from the shots. Instead, the vaccine contains a piece of genetic code that trains the immune system to recognize the spiked protein on the surface of the virus.

On the day Britain began its vaccination campaign, authorities warned people with severe allergies not to get the shot after two people suffered serious allergic reactions; it’s unclear if the reactions were caused by the vaccine.

The U.S. Centers for Disease Control and Prevention said that as of Friday there had been six cases of severe allergic reaction in the U.S. out of more than a quarter-million shots of the BioNTech-Pfizer vaccine given, including in one person with a history of vaccination reactions.

Adding to an already grisly toll were concerns over a newly identified strain that appears to spread more easily. But experts expressed confidence that the new vaccine would still be effective against it.

“At the moment, we can say that there is no evidence to suggest that the vaccine will not work against the new variant of the coronavirus,” Emer Cooke, the head of the drug regulator, said after a closed-door meeting in which experts unanimously recommended the shot for people over 16.

But she added that protective measures such as wearing masks, washing hands, and social distancing would likely be needed for some time.

“Vaccines alone will not be the silver bullet that will allow us to return to normal life,” said Cooke. “But the authorization of this first vaccine is definitely a major step in the right direction and an indication that 2021 can be brighter than 2020.”

The EU has ordered 300 million doses of the BioNTech-Pfizer vaccine; two are needed for each person, meaning other shots will be required to immunize all of the bloc’s nearly 450 million inhabitants.

The EMA plans to hold a meeting on Jan. 6 to decide if another vaccine made by Moderna should be licensed. It has reviews ongoing for a shot developed by Oxford University and AstraZeneca and another from Janssen, but neither of those have made a formal request for the EMA to approve their vaccine.

“Today is a particularly personal and emotional day for us at BioNTech,” said Ugur Sahin, the Germany-based company’s chief executive, and co-founder. “Being in the heart of the EU, we are thrilled to be one step closer to potentially delivering the first vaccine in Europe to help combat this devastating pandemic.”

___

Jordans reported from Berlin. Associated Press writers Maria Cheng in Toronto and Lorne Cook in Brussels contributed to this report.

Source: https://time.com/5923862/biontech-pfizer-covid-19-vaccine-european-union/

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With just 10% of the world’s population, Europe accounts for almost a quarter of the 1.2 million deaths globally, and even its well-equipped hospitals are feeling the strain.

After achieving a measure of control over the pandemic with broad lockdowns earlier this year, case numbers have surged since the summer and governments have ordered a second series of restrictions to limit social contacts.

In all, Europe has reported some 12.8 million cases and about 300,114 deaths. Over the past week, it has seen 280,000 cases a day, up 10% from the week earlier, representing just over half of all new infections reported globally.

Hopes have been raised by Pfizer Inc’s PFE.N announcement of a potentially effective new vaccine, but it is not expected to be generally available before 2021, and health systems will have to cope with the winter months unaided.

Britain, which has imposed a fresh lockdown in England, has the highest death toll in Europe at around 49,000, and health experts have warned that with a current average of more than 20,000 cases daily, the country will exceed its “worst case” scenario of 80,000 deaths.

France, Spain, Italy, and Russia have also reported hundreds of deaths a day, and together, the five countries account for almost three-quarters of the total fatalities.

Already facing the prospect of a wave of job losses and business failures, governments across the region have been forced to order control measures including local curfews, closing non-essential shops, and restricting movement.

France, the worst-affected country in the EU, has registered more than 48,700 infections per day over the past week and the Paris region’s health authority said last week that 92% of its ICU capacity was occupied.

Facing similar pressures, Belgian and Dutch hospitals have been forced to send some severely ill patients to Germany.

In Italy, which became a global symbol of the crisis when army trucks were used to transport the dead during the early months of the pandemic, daily average new cases are at a peak at more than 32,500. Deaths have been rising by more than 320 per day over the past three weeks.

While the new vaccine being developed by Pfizer and German partner BioNTech 22UAy.F will take time to arrive, authorities are hoping that once winter is passed, it will stem further outbreaks next year.

Citi Private Bank analysts described the news as “the first major advance toward a Post-COVID world economy”.

“More than any fiscal spending package or central bank lending programme, a healthcare solution to COVID has the greatest potential to restore economic activity to its full potential…” it said in a note.

European Commission President Ursula von der Leyen on Monday said the European Union would soon sign a contract for 300 million doses of the vaccine, just hours after the drugmaker announced promising late-stage trials.

Yet health experts cautioned that the vaccine, should it be approved, was no silver bullet – not least because the genetic material it’s made from needs to be stored at temperatures of minus 70 degrees Celsius (-94 F) or below.

Such requirements pose a challenge for countries in Asia, as well as Africa and Latin America, where intense heat is often compounded by poor infrastructure.

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