Novavax, Inc., a global company advancing protein-based vaccines with its novel Matrix-M™ adjuvant, today announced that its updated protein-based XBB COVID vaccine candidate induced neutralizing antibody responses to the EG.5.1 and XBB.1.16.6 subvariants in small animal and non-human primate studies. XBB sublineage variants are overwhelmingly responsible for the majority of current COVID cases in the U.S. and European Union.
Our data have shown that Novavax’s protein-based COVID vaccine induces broadly neutralizing responses against XBB subvariants, including EG.5.1 and XBB.1.16.6. We have a lot of confidence in our updated COVID vaccine and are working diligently with global regulatory bodies to ensure our protein-based vaccine is available this fall.”
Filip Dubovsky, President of Research and Development, Novavax
Non-clinical data previously showed that Novavax’s COVID vaccine candidate induced functional immune responses for XBB.1.5, XBB.1.16 and XBB.2.3 variants, indicating a broad response that could potentially be applicable for forward-drift variants.3 Novavax is in the process of submitting applications for its XBB.1.5 COVID vaccine candidate to regulatory authorities globally.
Use of the Novavax COVID-19 vaccine, adjuvanted in the U.S.
The Novavax COVID-19 Vaccine, Adjuvanted vaccine has not been approved or licensed by the U.S. FDA, but has been authorized for emergency use by FDA, under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID-19) as a primary series in individuals 12 years of age and older. The Novavax COVID-19 Vaccine, Adjuvanted vaccine is also authorized to provide a first booster dose at least 6 months after completion of primary vaccination with an authorized or approved COVID-19 vaccine to individuals 18 years of age and older for whom an FDA-authorized mRNA bivalent COVID-19 booster vaccine is not accessible or clinically appropriate, and to individuals 18 years of age and older who elect to receive the Novavax COVID-19 Vaccine, Adjuvanted because they would otherwise not receive a booster dose of a COVID-19 vaccine.
The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of the medical product under Section 564(b)(1) of the FD&C Act unless the declaration is terminated or authorization revoked sooner.
Authorized use
The Novavax COVID-19 Vaccine, Adjuvanted is authorized for use under an Emergency Use Authorization (EUA) to provide a two-dose primary series for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 12 years of age and older. The Novavax COVID-19 Vaccine, Adjuvanted vaccine is also authorized to provide a first booster dose at least 6 months after completion of primary vaccination with an authorized or approved COVID-19 vaccine to individuals 18 years of age and older for whom an FDA-authorized mRNA bivalent COVID-19 booster vaccine is not accessible or clinically appropriate, and to individuals 18 years of age and older who elect to receive the Novavax COVID-19 Vaccine, Adjuvanted because they would otherwise not receive a booster dose of a COVID-19 vaccine.
Important safety information
Contraindications
Do not administer the Novavax COVID-19 Vaccine, Adjuvanted to individuals with a known history of a severe allergic reaction (e.g., anaphylaxis) to any component of the Novavax COVID-19 Vaccine, Adjuvanted.
Warnings and precautions
Management of Acute Allergic Reactions: Appropriate medical treatment to manage immediate allergic reactions must be immediately available in the event an acute anaphylactic reaction occurs following administration of the Novavax COVID-19 Vaccine, Adjuvanted. Monitor the Novavax COVID-19 Vaccine, Adjuvanted recipients for the occurrence of immediate adverse reactions according to the Centers for Disease Control (CDC) and Prevention guidelines.
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Myocarditis and Pericarditis: Clinical trials data provide evidence for increased risks of myocarditis and pericarditis following administration of the Novavax COVID-19 Vaccine, Adjuvanted (see Full EUA Prescribing Information). The CDC has published considerations related to myocarditis and pericarditis after vaccination, including for vaccination of individuals with a history of myocarditis or pericarditis (https://www.cdc.gov/vaccines/covid-19/clinical-considerations/interim-considerations-us.html#myocarditis-pericarditis).
Syncope (fainting): May occur in association with administration of injectable vaccines. Procedures should be in place to avoid injury from fainting.
Altered Immunocompetence: Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to the Novavax COVID-19 Vaccine, Adjuvanted.
Limitations of Vaccine Effectiveness: The Novavax COVID-19 Vaccine, Adjuvanted may not protect all vaccine recipients.
Adverse reactions
Adverse reactions reported in clinical trials following administration of the Novavax COVID-19 Vaccine, Adjuvanted include injection site pain/tenderness, fatigue/malaise, muscle pain, headache, joint pain, nausea/vomiting, injection site redness, injection site swelling, fever, chills, injection site pruritus, hypersensitivity reactions, lymphadenopathy-related reactions, myocarditis, and pericarditis.
Myocarditis, pericarditis, anaphylaxis, paresthesia, and hypoesthesia have been reported following administration of the Novavax COVID-19 Vaccine, Adjuvanted outside of clinical trials.
Additional adverse reactions, some of which may be serious, may become apparent with more widespread use of the Novavax COVID-19 Vaccine, Adjuvanted.
Reporting adverse events and vaccine administration errors
The vaccination provider enrolled in the federal COVID-19 Vaccination Program is responsible for mandatory reporting of the following to the Vaccine Adverse Event Reporting System (VAERS):
vaccine administration errors whether or not associated with an adverse event,
serious adverse events (irrespective of attribution to vaccination),
cases of myocarditis,
cases of pericarditis,
cases of Multisystem Inflammatory Syndrome (MIS), in adults and children, and
cases of COVID-19 that results in hospitalization or death.
Complete and submit reports to VAERS online: For further assistance with reporting to VAERS, call 1-800-822-7967. The reports should include the words “Novavax COVID-19 Vaccine, Adjuvanted EUA” in the description section of the report.
Some Ontario doctors have started offering a free shot that can protect babies from respiratory syncytial virus while Quebec will begin its immunization program next month.
The new shot called Nirsevimab gives babies antibodies that provide passive immunity to RSV, a major cause of serious lower respiratory tract infections for infants and seniors, which can cause bronchiolitis or pneumonia.
Ontario’s ministry of health says the shot is already available at some doctor’s offices in Ontario with the province’s remaining supply set to arrive by the end of the month.
Quebec will begin administering the shots on Nov. 4 to babies born in hospitals and delivery centers.
Parents in Quebec with babies under six months or those who are older but more vulnerable to infection can also book immunization appointments online.
The injection will be available in Nunavut and Yukon this fall and winter, though administration start dates have not yet been announced.
This report by The Canadian Press was first published Oct. 21, 2024.
-With files from Nicole Ireland
Canadian Press health coverage receives support through a partnership with the Canadian Medical Association. CP is solely responsible for this content.
ISLAMABAD (AP) — Polio cases are rising ahead of a new vaccination campaign in Pakistan, where violence targeting health workers and the police protecting them has hampered years of efforts toward making the country polio-free.
Since January, health officials have confirmed 39 new polio cases in Pakistan, compared to only six last year, said Anwarul Haq of the National Emergency Operation Center for Polio Eradication.
The new nationwide drive starts Oct. 28 with the aim to vaccinate at least 32 million children. “The whole purpose of these campaigns is to achieve the target of making Pakistan a polio-free state,” he said.
Pakistan regularly launches campaigns against polio despite attacks on the workers and police assigned to the inoculation drives. Militants falsely claim the vaccination campaigns are a Western conspiracy to sterilize children.
Most of the new polio cases were reported in the southwestern Balochistan and southern Sindh province, following by Khyber Pakhtunkhwa province and eastern Punjab province.
The locations are worrying authorities since previous cases were from the restive northwest bordering Afghanistan, where the Taliban government in September suddenly stopped a door-to-door vaccination campaign.
Afghanistan and Pakistan are the two countries in which the spread of the potentially fatal, paralyzing disease has never been stopped. Authorities in Pakistan have said that the Taliban’s decision will have major repercussions beyond the Afghan border, as people from both sides frequently travel to each other’s country.
The World Health Organization has confirmed 18 polio cases in Afghanistan this year, all but two in the south of the country. That’s up from six cases in 2023. Afghanistan used a house-to-house vaccination strategy this June for the first time in five years, a tactic that helped to reach the majority of children targeted, according to WHO.
Health officials in Pakistan say they want the both sides to conduct anti-polio drives simultaneously.
WASHINGTON (AP) — Millions of people with private health insurance would be able to pick up over-the-counter methods like condoms, the “morning after” pill and birth control pills for free under a new rule the White House proposed on Monday.
Right now, health insurers must cover the cost of prescribed contraception, including prescription birth control or even condoms that doctors have issued a prescription for. But the new rule would expand that coverage, allowing millions of people on private health insurance to pick up free condoms, birth control pills, or “morning after” pills from local storefronts without a prescription.
The proposal comes days before Election Day, as Vice President Kamala Harris affixes her presidential campaign to a promise of expanding women’s health care access in the wake of the U.S. Supreme Court’s decision to undo nationwide abortion rights two years ago. Harris has sought to craft a distinct contrast from her Republican challenger, Donald Trump, who appointed some of the judges who issued that ruling.
“The proposed rule we announce today would expand access to birth control at no additional cost for millions of consumers,” Health and Human Services Secretary Xavier Becerra said in a statement. “Bottom line: women should have control over their personal health care decisions. And issuers and providers have an obligation to comply with the law.”
The emergency contraceptives that people on private insurance would be able to access without costs include levonorgestrel, a pill that needs to be taken immediately after sex to prevent pregnancy and is more commonly known by the brand name “Plan B.”
Without a doctor’s prescription, women may pay as much as $50 for a pack of the pills. And women who delay buying the medication in order to get a doctor’s prescription could jeopardize the pill’s effectiveness, since it is most likely to prevent a pregnancy within 72 hours after sex.
If implemented, the new rule would also require insurers to fully bear the cost of the once-a-day Opill, a new over-the-counter birth control pill that the U.S. Food and Drug Administration approved last year. A one-month supply of the pills costs $20.
Federal mandates for private health insurance to cover contraceptive care were first introduced with the Affordable Care Act, which required plans to pick up the cost of FDA-approved birth control that had been prescribed by a doctor as a preventative service.
The proposed rule would not impact those on Medicaid, the insurance program for the poorest Americans. States are largely left to design their own rules around Medicaid coverage for contraception, and few cover over-the-counter methods like Plan B or condoms.