Here are several recent articles from the Wall Street Journal on the treatment and prevention of Covid 19.
Bottom Line: We will run out of monoclonal antibody treatment in late August. If the government doesn’t pay for it, will you and/or your insurance company? That remains to be seen. Fortunately, I haven’t been using a lot of it recently, though I have prescribed a lot of Paxlovid. It appears that we will have enough of the latter available through the end of the year. That runs about $500 a dose. The U.S. government is presently footing the bill, but what happens next year?
Studies on antibody response to new vaccines which target the original virus and the Omicron variant look very promising and these are what have been ordered for the fall. It looks like you will get your flu vaccine first, followed by the new Covid 19 vaccine when it is available.
U.S. Agrees to Pay $3.2 Billion for More Pfizer Covid Vaccines
Under the deal, the U.S. government will get 105 million doses and have the option to purchase more
and Jared S. Hopkins
Updated June 29, 2022 6:38 pm ET
The Biden administration has agreed to pay $3.2 billion for 105 million doses of Pfizer Inc.’s Covid-19 vaccine.
The deal would provide supplies for the federal government’s planned fall booster campaign, which administration officials are devising to blunt a potential wave in cases, possibly driven by variants of the Omicron strain now spreading across the U.S.
Under the deal, the federal government would have the option to buy 195 million additional doses, the Health and Human Services Department said Wednesday. Pfizer, which developed and makes the vaccine with partner BioNTech SE, would make whatever type of vaccine federal health regulators decide should be featured in the fall campaign.
“We look forward to taking delivery of these new variant-specific vaccines and working with state and local health departments, pharmacies, healthcare providers, federally qualified health centers, and other partners to make them available in communities around the country this fall,” said Dawn O’Connell, the assistant secretary for preparedness and response at HHS.
The administration is facing a funding shortage for pandemic response efforts amid a stalemate in Congress over additional money to deal with the virus. Earlier this month, the U.S. reallocated $10 billion in existing Covid-19 response funding for vaccines and treatment. The funding for the additional vaccines comes from that reallocated money, the administration said.
The purchase agreement for the Pfizer-BioNTech Covid-19 vaccine is the latest sign that the Biden administration is ramping up preparations for a fall booster campaign.
Dr. Ashish Jha, the White House’s Covid-19 coordinator, said the administration doesn’t have adequate funding to purchase enough vaccines for every American who may need them. “We will not be able to secure new vaccines to protect all Americans who would benefit from the best protection possible against COVID-19,” he said in a statement. “It’s time for Congress to step up to protect the American people.”
The purchase agreement is the latest sign of the Biden administration’s ramping up preparations for a new booster drive.
On Tuesday, vaccine experts advising the Food and Drug Administration recommended the agency direct vaccine makers to make shots that involve targeting the Omicron variant. FDA officials told the advisers the agency would need to make a decision on the composition of the shots by early July.
Pfizer and BioNTech tested a vaccine that targeted Omicron specifically and a shot targeting Omicron and the ancestral strain of the virus. Moderna Inc., which sells the other widely used Covid-19 vaccine, tested a shot modified to target Omicron and the ancestral strain.
The U.S. expects the Pfizer vaccine doses could arrive in the early fall, HHS said.
“As the virus evolves, this new agreement will help ensure people across the country have access to vaccines that may provide protection against current and future variants,” Pfizer Chief Executive Albert Bourla said.
Sean Marett, BioNTech’s chief business and chief commercial officer, said the agreement will help the U.S. cope with the next Covid-19 wave and the rapidly spreading Omicron variant.
Some of the Pfizer vaccines would be delivered in single-dose vials, a common feature for vaccines of other illnesses and a departure from the multi-dose containers that the vaccine has been distributed in since December 2020.
Single-dose vials could reduce the number of doses wasted. Sometimes, not all of the vaccines in multi-dose vials are used.
At $3.2 billion, the cost per dose comes to roughly $30.50, compared with $19.50 from the initial contract for 100 million doses the drugmakers and government agreed to two years ago.
The new supply agreement will add to the substantial sales generated by the vaccine. Analysts from JP Morgan & Chase Co. forecast the vaccine will generate roughly $34 billion in sales this year for Pfizer.
The contract brings the total doses purchased by the U.S. to more than 900 million, with 500 million bought at not-for-profit prices and destined as donations to developing nations. The other 300 million doses were for the U.S.
Currently authorized Covid-19 vaccines, including those from Moderna and Pfizer-BioNTech, were designed to target the ancestral coronavirus strain that emerged in China in late 2019.
Yet studies have shown these shots are less effective at protecting people from infection by the Omicron variant since it emerged in late 2021 and quickly became dominant, including its offshoots.
U.S. Supply of Effective Covid Antibody Drug Dwindling
Last doses of the drug, one of few found to reduce risk of severe disease even after Omicron, will be used up in August without more pandemic funding, officials say
and Liz Essley Whyte
Updated June 29, 2022 10:42 am ET
The federal government’s stores of a key Covid-19 antibody drug, a crucial weapon for keeping the infected out of the hospital, are expected to be used up in late August because pandemic funding is running out.
Biden administration officials have told Congress that the government’s supply of the Eli Lilly & Co. therapy, the only antibody drug for treating nonhospitalized patients that was found to work against Omicron, could run out if pandemic funding isn’t renewed. The supply could be depleted before fall if the pace of current use holds.
Should the federal government be unable to procure more doses, Lilly would need to sell the drug to hospitals and states directly for the treatment to remain available. That would provide a first test of whether pandemic-related drugs and vaccines would remain accessible if shifted to the commercial market.
So far during the pandemic, the federal government has been buying and distributing Covid-19 medicines to ensure there are doses available around the U.S., rather than in certain areas able to pay and secure more.
Bebtelovimab is the only Covid antibody drug for nonhospitalized patients found to work against the Omicron variant.
Lilly, which makes the antibody drug bebtelovimab, said it prefers to keep selling it to the federal government but would make it commercially available if funding dries up.
“Our commitment remains to work to keep bebtelovimab available to patients who need it in the U.S., but believe that collaborations with the U.S. government are crucial to ensuring fair and equitable access to all states,” a company spokeswoman said.
Biden administration officials have been sounding the alarm about dwindling supplies of Covid-19 vaccines, drugs and other products in a bid to pressure Congress to approve a new round of funding.
Republicans have said the administration should tap unspent pandemic funds before any new spending is authorized. Republicans also have said it is time for the federal government to give up its pandemic procurement of many products.
“Does the FDA have a plan to allow states or healthcare providers to purchase vaccines and treatments, to help put purchasing decisions back in the hands of the American public instead of the federal government?,” GOP Sen. Richard Burr of North Carolina said at a June 16 hearing, referring to the Food and Drug Administration.
In recent testimony before Congress, Biden administration officials said the absence of new funding has prompted it to shift $300 million currently allocated for pandemic response to buying more antibody drugs and away from Covid-19 testing and personal protective equipment.
Lilly said Wednesday it reached a deal to sell 150,000 doses of bebtelovimab to the U.S. for $275 million, which means $1,833 per dose. The agreement includes an option for an additional 350,000 doses to be exercised no later than Sept. 14.
The federal government is distributing about 30,000 doses a week of the therapy, according to the Health and Human Services Department.
The treatment is among several developed to mimic naturally occurring immune-system antibodies able to fight off the coronavirus. After the Omicron variant hit, testing found that several other antibody drugs were unlikely to work, prompting the government to restrict their use.
Bebtelovimab still worked, however, and has been given to the nonhospitalized at high risk of severe Covid-19.
Hospitals and clinics administer it by infusion. The newly infected seeking to avoid severe disease can also, instead, take two antiviral pills also in use: Pfizer Inc.’s Paxlovid or Lagevrio from Merck & Co. and Ridgeback Biotherapeutics LP.
The Biden administration has said it has purchased enough Paxlovid and Lagevrio to likely last through the end of the year at the current rate of use.
Shifting bebtelovimab to the commercial market would entail changes, administration officials have said. Health insurers would need to make determinations about whether to cover the treatment and how much to pay Lilly for the doses and hospitals for the administration of the infusions.
Administration officials seeking more Covid-19 funding have said the government’s size gives it stronger negotiating power with drugmakers to keep down costs while ensuring equitable access.
So far during the pandemic, the federal government has been buying and distributing Covid-19 medicines to ensure there are doses available around the U.S.
Officials also have said it is too early for the commercial market to take over. That could give a procurement advantage to other countries offering larger contracts, Dr. Ashish Jha, the White House’s Covid-19 response coordinator, said in a June 23 press briefing.
“There’s not an easy way to make sure that the commercial purchasers somehow get in and beat out other countries to have product available,” he said.
The federal government began purchasing Covid-19 treatments and vaccines when supplies of those products were scarce or uncertain, said Paul Mango, a Health and Human Services department liaison to Operation Warp Speed during the Trump administration.
The federal purchases now are unnecessary and a boon to Eli Lilly, he said. “It wasn’t ever designed or intended to be ad infinitum.”
The administration had asked for $30 billion for Covid-19 funding but reduced that to $22.5 billion, an amount that was further whittled down to about $10 billion in a compromise measure that now has stalled.
The administration has repurposed about $10 billion in Covid-19 funding in part to purchase some potentially updated vaccines for the fall.
Pfizer’s Omicron-Targeting Covid-19 Vaccines Generate Stronger Immune Response
One shot that was tested targeted Omicron specifically, while another was modified to work against the strain and the original virus
A modified booster shot targeting Omicron specifically increased neutralizing antibody levels 13.5 to 19.6 times higher than the current shot in study volunteers a month after administration, depending on the dose, the companies said Saturday.
A booster targeting both Omicron and the original virus increased neutralizing antibody levels 9.1 to 10.9 times, depending on the dose, the companies said.
Both of the tweaked vaccine candidates were well tolerated by subjects in the study, the companies said.
The results, coming after Moderna Inc. also found its Omicron-targeting booster produced a stronger immune response, suggest possible benefit to modifying the shots to improve protection against an evolving virus.
Since the start of the Covid-19 pandemic in 2020, the scientific understanding of its transmission and prevention has evolved. WSJ’s Daniela Hernandez explains what strategies have worked for stemming the spread of the virus and which are outdated in 2022. Illus
Federal health authorities are trying to decide whether to stick with the current shots for a fall vaccination campaign or use a tweaked version. Studies have found that the current vaccines don’t work as well against Omicron as they did against earlier strains. THE FDA DECIDED ON THE TWEAKED VERSION.
“Based on these data, we believe we have two very strong Omicron-modified candidates that elicit a substantially higher immune response against Omicron than we’ve seen to date,” Pfizer Chief Executive Albert Bourla said.
The study didn’t measure whether and how well the shots reduced the risk of Covid-19. Pfizer and BioNTech announced the results by news release. The findings haven’t been published in a peer-reviewed medical journal.
Omicron is the most recent strain of the virus to come to predominate in the U.S. and many other countries.