FDA lays groundwork for variant-focused vaccinesFebruary 23, 2021
Presented by the Pharmaceutical Care Management Association
With help from Emily Martin, Brianna Ehley
— FDA lays groundwork for variant-focused vaccines and urges manufacturers to study options.
— Today: House hearing on Covid vaccines plus a big J&J production pledge.
— This week: HHS nominees at that Senate potentially clearing the way for an FDA pick.
It’s Tuesday, welcome back to Prescription Pulse. I'm absolutely coronamüde, but trying not to be an Impfneid for the lucky people in line. Which words capture this moment for you? As always, send tips to Sarah Owermohle ([email protected] or @owermohle) and David Lim ([email protected] or @davidalim).
FDA LAYS GROUNDWORK FOR VARIANT-FOCUSED VACCINES — Trials for coronavirus booster shots aimed at emerging strains can be narrower than those for the original Covid-19 vaccines, as long as those studies prove the booster provokes an immune response, the agency said on Monday.
There are still open questions. While new guidance says manufacturers should carry out trials comparing the modified vaccines to original versions and administering the updated shots to already vaccinated people, it did not say how many people would actually need to be enrolled in trials or how long they should take.
Peter Marks, FDA’s director for the Center for Biologics Evaluation and Research, told reporters that “a few hundred” people should be in each trial, which could take a few months.
That could change. “Ultimately, the sponsors will need to work with FDA regarding their specific products and determine the most appropriate clinical data needed to support a new vaccine authorization or modified vaccine authorization,” a spokesperson told POLITICO.
FDA left the door open to additional changes. Its guidance document says that "further discussions will be necessary" to decide whether the agency could at some point authorize modified Covid-19 vaccines "without the need for clinical studies."
But manufacturers should start now. Vaccine makers should get started on trials for modified vaccines "sooner rather than later" because of the time that goes into them and the possibility of more variant spread, said Marks. “We think it’s prudent.”
FDA medical device director Jeff Shuren told reporters the agency is considering using in silico modeling to assess how antigen tests that are already on the market perform against emerging variants.
“We continue to monitor if there are changes in [antigen] test performance, but at the present time, we have not seen any such signs,” Shuren said.
Regulators say they are weighing whether to require developers to evaluate the impact of key virus mutations on the performance of their tests. The agency plans to evaluate new tests against known Covid-19 variants during product review and ask developers to submit post-authorization monitoring plans.
NOVAVAX COMPLETES U.S. TRIAL ENROLLMENT — Maryland-based Novavax announced Monday it has completed enrollment of 30,000 clinical trial volunteers to test its Covid-19 vaccine candidate across 118 sites in the U.S. and Mexico.
LABS ASK WHITE HOUSE TO REVISE TEST COVERAGE GUIDELINES — The American Clinical Laboratory Association asked the Biden administration Monday to strengthen insurance coverage requirements for Covid-19 testing and replenish the Health Resources & Services Administration’s uninsured test fund.
“Uncertainty about coverage and costs has created unnecessary barriers for many patients to access COVID-19 testing,” ACLA President Julie Khani wrote to White House Covid-19 Response Coordinator Jeff Zients. “Over the course of this public health crisis, the protections Congress promised to patients have significantly eroded, exacerbated by the tri-agency guidance issued on June 23, 2020.”
Amazon, CVS, BD, Thermo Fisher and Whirlpool also called on the Biden administration to issue “consistent guidance” outlining how businesses should use tests to safely return employees to work. The group, known as The Workplace Employers Alliance for COVID-19 Testing, asked Zients on Friday to help expand the availability of pooled, rapid point-of-care, at-home and over-the-counter Covid-19 tests.
TODAY: HOUSE HEARING ON COVID VACCINES — Five major vaccine manufacturers will appear before a House panel this morning to discuss efforts to ramp up production and meet demand for millions of Americans.
Just two of those manufacturers — Pfizer and Moderna — make vaccines authorized for use in the the U.S. But a third, Johnson & Johnson, could join them as early as this weekend.
While each company has pledged hundreds of millions of shots to the federal government, state officials testified to the House Energy and Commerce Committee’s Oversight and Investigations panel last month that federal delays and confusion had hampered their vaccine rollout.
Who will be there: Pfizer’s John Young, chief business officer; Moderna President Stephen Hoge; Johnson & Johnson’s Richard Nettles, vice president of medical affairs for their pharmaceutical unit Janssen; AstraZeneca’s Ruud Dobber, president of the biopharmaceuticals unit and Novavax’s John Trizzino, chief commercial and chief business officer.
What will happen: J&J can deliver 20 million doses of its single-shot coronavirus vaccine to the U.S. government by the end of March, Nettles will testify.
“Assuming necessary regulatory approvals relating to our manufacturing processes, our plan is to begin shipping immediately upon emergency use authorization, and deliver enough single-doses by the end of March to enable the vaccination of more than 20 million Americans.” He will say. FDA is expected to grant emergency use authorization as early as this weekend, after an expert FDA panel convenes Friday to discuss the effectiveness and safety of J&J’s vaccine.
“It’s important that these companies are doing everything they can to produce these vaccines as quickly as possible so we can get them into the arms of more Americans,” said subcommittee chair Diana DeGette (D-Colo.) “We want to know what these companies are doing to ramp up production, and what else can be done to get these vaccines distributed sooner to those who need them.”
IN THE SENATE: BECERRA HEARINGS BEGIN — The first hearing for Biden’s HHS pick, Xavier Becerra, kicks off in the Senate HELP committee this morning, followed by a Finance committee hearing Wednesday and a vote on sending his nomination to the floor.
Becerra and his allies plan to highlight his long track record in the House of Representatives before he became California Attorney General, plus his record prosecuting opioid and tobacco manufacturers.
He also will testify this morning about his own family’s health struggles, including his father’s death earlier this year and his mother’s life-threatening miscarriage when he was a child, Alice Miranda Ollstein reports. Becerra will pledge to work across party lines on vaccine distribution, she adds.
PUSH TO PERMANENTLY SCHEDULE FENTANYL-RELATED SUBSTANCES — Sens. Rob Portman (R-Ohio) and Joe Manchin (D-W.Va.) on Monday introduced legislation to permanently schedule fentanyl-related substances, which are under a temporary scheduling order until May 6.
The legislation, which comes as overdose deaths continue to climb, would allow law enforcement authorities to continue bringing criminal charges against individuals who manufacture, distribute or handle fentanyl-related substances. CDC data released last week show overdose fatalities are projected to surpass 86,000 in 2020, driven in large part by fentanyl use.
FDA ADDRESSES PULSE OXIMETER RISKS — Skin color, nail polish, tobacco use, skin temperature and other factors can affect the accuracy of pulse oximeters used to estimate blood oxygen levels, FDA said in a safety communication issued Friday.
Patients and health care providers should not solely rely on pulse oximeter readings when monitoring illnesses like Covid-19 at home, according to William Maisel, the director of FDA’s Office of Product Evaluation and Quality for medical devices.
Why it matters: The agency's safety notice comes after increasing concern about racial disparities in the accuracy of pulse oximeter data, driven in part by increased consumer use of the devices during the pandemic.
FDA acknowledged a study published last year that found pulse oximeters performed worse among Black patients than white patients. That could increase the risk that Black patients with low oxygen levels do not receive needed treatment, concluded the study's authors, a team from the University of Michigan Medical School.
TODAY: The House Energy and Commerce subcommittee on Oversight and Investigations holds a hearing with five vaccine manufacturers.
Biden’s HHS nominee Xavier Becerra appears before the Senate HELP Committee.
WEDNESDAY: Becerra appears before the Senate Finance Committee, which will ultimately vote on sending his nomination to the floor.
Surgeon General nominee Vivek Murthy and assistant secretary of HHS nominee Rachel Levine appear before the Senate HELP Committee.
THURSDAY: Moderna holds its earnings call at 8 a.m.
FRIDAY: Vaccines and Related Biological Products Advisory Committee convenes to discuss the safety and efficacy of Johnson & Johnson’s coronavirus vaccine.
U.S. HOLDING OFF ON GLOBAL VAX DONATIONS — The Biden administration won’t donate to poor countries any of the coronavirus vaccine doses the U.S. has purchased before most Americans are vaccinated, a senior administration official told reporters last week.
The announcement came just before Biden joined the G7 virtual meeting, where nations were set to address anxiety over a global vaccine rollout, POLITICO’s Carmen Paun reported.
At the meeting, Biden pledged $4 billion over the next two years to COVAX, the global effort to fund and deliver Covid-19 vaccines around the world. Half the funding will subsidize vaccine purchases for poor countries while the remaining $2 billion is allocated to expand production.
The Biden administration said it expects to have enough vaccine doses for all Americans by the end of July.
U.K. ALSO AIMS FOR END OF SUMMER GOAL — U.K. Prime Minister Boris Johnson said all British adults will be offered a first dose of the coronavirus vaccine by July 31, POLITICO EU’s Louis Guillot reported.
"We will now aim to offer a jab to every adult by the end of July, helping us protect the most vulnerable sooner, and take further steps to ease some of the restrictions in place," Johnson said.
The July 31 date is a month earlier than the country's previous target. The announcement also came as the government is expected to present a plan to ease lockdown restrictions ahead of Easter.
— The Philippines approved Sinovac’s Covid-19 vaccine for emergency use, but officials said they will not give it to healthcare workers due to its varying levels of efficacy, Reuters reported.
— Sanofi has inked a deal with Johnson & Johnson to produce millions of doses of the rival’s vaccine as the French drugmaker faces development delays with its own candidates, AP reported.
— Chinese officials denied obstructing Taiwan’s coronavirus vaccine deal with BioNTech after the island claimed the purchase fell through due to possible “political pressure,” CNN reported.
— South Africa’s delegate at the World Trade Organization said that major pharmaceutical companies’ control of medicine production has to be confronted to provide fair access to vaccines, the Guardian reported.
FDA announced final guidance warning manufacturers about methanol contamination risks in drug compounding after people died from ingesting alcohol-based hand sanitizers contaminated with methanol during manufacturing.