Two new things:

There is a new monoclonal antibody that can be used every three months in immunocompromised patients to prevent infection. This will only be helpful to a small number of our patients.  Also, there will be a new Covid 19 vaccine in the fall. People have vaccine fatigue, but these vaccines have been about 50% effective in preventing any infection similar to flu vaccine (in a good year) and can prevent severe infection which leads to hospitalization.  i just added an article from this morning’s New York Times about the FDA’s official recommendation for a fall vaccine.

From The Medical Letter:

May 13, 2024

COVID-19 Update: An EUA for Pemivibart (Pemgarda) for Pre-Exposure Prophylaxis

Med Lett Drugs Ther. 2024 May 13;66(1702):79-80   doi:10.58347/tml.2024.1702e

Outline

• The New Product
• Clinical Studies
• Adverse Effects
• Dosage and Administration
• References

Table

• Some Immunocompromising Conditions

The FDA has issued an Emergency Use Authorization (EUA) for the long-acting investigational IV monoclonal antibody pemivibart (Pemgarda – Invivyd) for pre-exposure prophylaxis of COVID-19 in persons ≥12 years old (weight ≥40 kg) who have moderate to severe immune compromise and are unlikely to respond adequately to COVID-19 vaccination (see Table 1).1 Pemgarda is the only drug that is currently authorized in the US for pre-exposure prophylaxis of COVID-19. Tixagevimab/cilgavimab (Evusheld) was previously available under an EUA for this indication, but it lacks activity against currently circulating SARS-CoV-2 variants.2

THE NEW PRODUCT — Pemivibart is a human IgG1 monoclonal antibody derived from adintrevimab, an investigational antibody that was effective against the Delta variant of SARS-CoV-2, but not against circulating Omicron variants.3 Unlike adintrevimab, pemivibart has activity against the currently dominant JN.1 Omicron lineage of SARS-CoV-2.4 Pemivibart is catabolized slowly (median half-life 44.8 days).5

CLINICAL STUDIES — No clinical efficacy data were required for authorization of pemivibart. Issuance of the EUA was based on the results of an unpublished immunobridging trial (CANOPY Cohort A; summarized in the FDA Fact Sheet) in 306 adults with moderate to severe immune compromise. Titer levels of anti-SARS-CoV-2 JN.1 neutralizing antibodies 28 days after administration of one dose of pemivibart were compared to extrapolated titer levels of anti-SARS-CoV-2 B.1.617.2 (Delta) neutralizing antibodies 28 days after administration of a single adintrevimab dose in historical controls.

Results from the trial were mixed; antibody levels with pemivibart met the prespecified criteria for immunobridging when an authentic virus neutralization assay was used, but not when a pseudotyped virus-like particle neutralization assay was used. A supplementary analysis found the immunogenicity of pemivibart against the JN.1 variant to be consistent with the immunogenicity of other antibodies against SARS-CoV-2 variants that they successfully targeted.5

ADVERSE EFFECTS — A hypersensitivity or infusion-related reaction occurred in 9% of patients in CANOPY Cohort A. Anaphylaxis occurred in 0.6% of 623 patients who received pemivibart in clinical trials. Pemivibart contains polysorbate 80, which is similar in structure to polyethylene glycol and has been associated with hypersensitivity reactions to COVID-19 vaccines; an immunology consult should be considered before use in patients who had a severe hypersensitivity reaction to a COVID-19 vaccine.

Influenza-like illness, fatigue, headache, and nausea have also occurred with use of pemivibart.5

DOSAGE AND ADMINISTRATION — The recommended dosage of Pemgarda is 4500 mg infused intravenously over at least 60 minutes. Patients should be monitored during and for at least 2 hours after the infusion. Additional doses can be given every 3 months. Pemivibart should not be used for post-exposure prophylaxis or treatment of COVID-19, within 2 weeks after administration of a COVID-19 vaccine, or as a substitute for vaccination.5

REFERENCES

1. FDA News Release. FDA roundup: March 22, 2024. Available at: https://bit.ly/3xEwjhA. Accessed April 25, 2024.
2. COVID-19 update: Evusheld unlikely to neutralize XBB.1.5 omicron variant. Med Lett Drugs Ther 2023; 65:e25.
3. MG Ison et al. Prevention of COVID-19 following a single intramuscular administration of adintrevimab: results from a phase 2/3 randomized, double-blind, placebo-controlled trial (EVADE). Open Forum Infect Dis 2023; 10:ofad314. doi:10.1093/ofid/ofad314
4. CDC. COVID data tracker. Variant proportions. April 13, 2024. Available at: https://bit.ly/3Ka3HhH. Accessed April 25, 2024.
5. FDA. Fact sheet for healthcare providers: Emergency Use Authorization of Pemgarda (pemivibart). March 2024. Available at: https://bit.ly/3Q3K5AL. Accessed April 25, 2024.

© The Medical Letter, Inc. All Rights Reserved.

A vial labelled “VACCINE Coronavirus COVID-19” is seen in front of a stock graph in this illustration taken on January 17, 2022. REUTERS/Dado Ruvic/Illustration/File Photo Purchase Licensing Rights, opens new tab

June 3 (Reuters) – Advisers to the U.S. Food and Drug Administration will vote whether to recommend that COVID-19 vaccines for 2024-25 should target the JN.1 variant, the most dominant this year, documents filed on Monday showed.

Shares of Novavax (NVAX.O), opens new tab soared 11% in morning trade, after the documents were released. The company had said last month it would only be able to offer a COVID vaccine in the United States this autumn if regulators accept the shot it started manufacturing to target the JN.1 variant.

The FDA’s staff in separate documents said vaccine makers developing the new booster shots may need to consider targeting one of the JN.1 subvariants such as KP.2, as further evolution of the virus could take it away from the older strain.

The documents were posted ahead of the advisers’ meeting on Wednesday. The meeting was postponed from May 16 as the FDA sought more time to “obtain surveillance data and other information” on the circulating virus.

 

The FDA staff’s review for updating viral strains for vaccines in the U.S. differs from that of the World Health Organization’s advisers, who in April recommended, opens new tab targeting only the JN.1 strain.

Since then, the subvariant KP.2 has become the dominant strain in the U.S., estimated to account for about 28.5% of cases over a two-week period ended May 25, according to data from the U.S. Centers for Disease Control and Prevention.

“This change in epidemiology warrants consideration,” the reviewers said.

A variation in vaccine strain from the global norm could also pose a challenge for COVID vaccine makers, especially Novavax as it makes a more traditional protein-based shot that takes longer to manufacture.

Vaccines based on messenger RNA (mRNA), like those from Moderna (MRNA.O), opens new tab, or Pfizer (PFE.N), opens new tab and its partner BioNTech (22UAy.DE), opens new tab, can be developed more quickly. In the past, Pfizer had said it could make the shots in 100 days.

F.D.A. Advisers Recommend a New Covid Vaccine Formula for the Fall

The panel endorsed targeting a variant of the coronavirus that is now receding, though some officials suggested aiming at newer versions of the virus that have emerged in recent weeks.

By Noah Weiland and Christina Jewett

June 5, 2024

A committee of advisers to the Food and Drug Administration voted on Wednesday to update the formula for the Covid vaccine ahead of an anticipated fall immunization campaign, now an annual step to try to offer better protection against versions of the virus in circulation.

The unanimous vote by the 16 advisers recommends a formula aimed at combating the variant JN.1, which dominated infections in the United States in February, or a version of it. In recent weeks, JN.1 has been overtaken by descendants known as KP.2 and KP.3.

In the coming weeks, the F.D.A. is expected to formally recommend a variant target for vaccine makers for the next round of shots in the late summer or early fall. Any decision involves some educated guesswork, given that any new vaccine formula won’t be available until months after a variant becomes dominant.

“It’s becoming clear that the ideal timing for a vaccine composition decision remains elusive,” said Jerry Weir, an official with the F.D.A.’s vaccine division.

Dr. Peter Marks, who oversees that division, urged the committee to consider encouraging the mRNA vaccine makers to focus on the latest versions of the virus in broader circulation.

“We always say we shouldn’t be chasing strains, but we’re paying an incredibly high premium for mRNA vaccines to be able to have the freshest vaccines,” he said, referring to the technology used by Moderna and Pfizer. He compared the choice of a vaccine to selecting fresher milk at the grocery store.

“If this evolves further in the fall, will we regret not having been a little bit closer?” Dr. Marks asked.

But Dr. Sarah Meyer, a senior vaccines official at the Centers for Disease Control and Prevention, said that aiming at JN.1 was more appropriate because it was “further up on the tree” in the evolution of the coronavirus, possibly allowing the vaccines to better cover mutations in the virus later this year.

The federal government’s plans for a Covid inoculation campaign, she added, had assumed the distribution of a JN.1 option.

“I think it’s just really hard to predict what is going to happen and where things are going to go,” she said.

The decision by advisers on Wednesday aligned with guidance from the World Health Organization expert committee, which recommended in April that Covid vaccines switch to a JN.1 formulation.

The F.D.A. advisers reviewed data showing that as of late May, the KP versions of the virus accounted for roughly half of coronavirus cases across the nation, a sign that they would continue to spread more broadly than JN.1.

Representatives of Moderna and Pfizer said that the companies would be ready to produce either version of the vaccine.

Novavax, which uses a different vaccine-development technology, said that it would target JN.1. Dr. Robert Walker, the chief medical officer for the company, said it would be effective in neutralizing the KP strains.

Studies have shown that protection tends to improve as the vaccines more precisely target dominant variants, according to the F.D.A.

On Wednesday, federal officials presented an optimistic portrait of the nation’s fight against Covid. Cases were relatively low, said Natalie J. Thornburg, a C.D.C. official, with data showing that illnesses from JN.1 were not more severe than those from earlier variants.

Fewer than 400 Covid deaths a week have been recorded recently, down from a peak of roughly 2,500 a week over the winter, according to initial data collected by the C.D.C. Older Americans represented a significant portion of patients hospitalized with Covid.

Last year’s coronavirus vaccination rate was tepid. In March, C.D.C. researchers reported that only 18 percent of immunocompromised adults had received the updated vaccine, which provided increased protection against hospitalization. More broadly, just over 20 percent of adults received the shot, C.D.C. data show.

The lukewarm embrace of updated immunizations extended to nursing home residents, who have been among those most likely to suffer from severe illness, hospitalization or death. Data from the C.D.C. showed that in May, about 30 percent of nursing home residents were up-to-date on their Covid shots, down from 65 percent two years ago.

Noah Weiland writes about health care for The Times. More about Noah Weiland

Christina Jewett covers the Food and Drug Administration, which means keeping a close eye on drugs, medical devices, food safety and tobacco policy. More about Christina Jewett