GAITHERSBURG, Md., April 22, 2022/PRNewswire/ — Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, has initiated administration of the first booster doses of NVX-CoV2373, the company’s protein-based COVID-19 vaccine, in the pediatric expansion of the PREVENT-19 pivotal Phase 3 clinical trial. The study will evaluate the safety and immunogenicity of a third dose of NVX-CoV2373 among trial participants aged 12 through 17.
“We see the ongoing need for alternative vaccine options because we are continuing to monitor spikes in COVID-19,” said Gregory M. Glenn, M.D., President, Research and Development, Novavax. “The expansion of our PREVENT-19 booster trial into the pediatric population reinforces our commitment to seek to make our vaccine available to a broader population.”
All PREVENT-19 trial participants aged 12 through 17 are now eligible to receive a third booster dose of NVX-CoV2373. The booster dose is identical to the active vaccine previously administered to the participants in a two-dose regimen (5 micrograms of recombinant spike protein plus 50 micrograms of Matrix-M™ adjuvant) and may be administered at least five months after receipt of active vaccine. Post-booster objectives include the assessment of the humoral immune response 28 days after the administration of the booster dose, as well as describing COVID-19 disease. Initial results are expected during the second half of 2022.
Findings from the pediatric expansion of the PREVENT-19 pivotal Phase 3 trial were announced in February.
Authorization in the U.S.
NVX-CoV2373 has not yet been authorized for use in the U.S. by the U.S. Food and Drug Administration.
About NVX-CoV2373
NVX-CoV2373 is a protein-based vaccine engineered from the genetic sequence of the first strain of SARS-CoV-2, the virus that causes COVID-19 disease. NVX-CoV2373 was created using Novavax’ recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein and is formulated with Novavax’ patented saponin-based Matrix-M™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies. NVX-CoV2373 contains purified protein antigen and can neither replicate, nor can it cause COVID-19.
Novavax’ COVID-19 vaccine is packaged as a ready-to-use liquid formulation in a vial containing ten doses. The vaccination regimen calls for two 0.5 ml doses (5 mcg antigen and 50 mcg Matrix-M™ adjuvant) given intramuscularly 21 days apart. The vaccine is stored at 2°- 8° Celsius, enabling the use of existing vaccine supply and cold chain channels. Use of the vaccine should be in accordance with official recommendations.
Novavax has established partnerships for the manufacture, commercialization and distribution of NVX-CoV2373 worldwide. Existing authorizations leverage Novavax’ manufacturing partnership with Serum Institute of India, the world’s largest vaccine manufacturer by volume. They will later be supplemented with data from additional manufacturing sites throughout Novavax’ global supply chain.
About the NVX-CoV2373 Phase 3 Trials
NVX-CoV2373 is being evaluated in two pivotal Phase 3 trials.
PREVENT-19 (the PRE-fusion protein subunit Vaccine Efficacy Novavax Trial | COVID-19) is a 2:1 randomized, placebo-controlled, observer-blinded trial to evaluate the efficacy, safety and immunogenicity of NVX-CoV2373 with Matrix-M™ adjuvant in 29,960 participants 18 years of age and older in 119 locations in the U.S. and Mexico. The primary endpoint for PREVENT-19 was the first occurrence of PCR-confirmed symptomatic (mild, moderate or severe) COVID-19 with onset at least 7 days after the second dose in serologically negative (to SARS-CoV-2) adult participants at baseline. The statistical success criterion included a lower bound of 95% CI >30%. A secondary endpoint was the prevention of PCR-confirmed, symptomatic moderate or severe COVID-19. Both endpoints were assessed at least seven days after the second study vaccination in volunteers who had not been previously infected with SARS-CoV-2. In the trial, NVX-CoV2373 achieved 90.4% efficacy overall. It was generally well-tolerated and elicited a robust antibody response after the second dose in both studies. Full results of the trial were published in the New England Journal of Medicine (NEJM).
PREVENT-19 is being conducted with support from the U.S. government, including the Department of Defense, the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services (HHS), and the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health at HHS. BARDA is providing up to $1.75 billion under a Department of Defense agreement.
Additionally, a trial conducted in the U.K. with 14,039 participants aged 18 years and older was designed as a randomized, placebo-controlled, observer-blinded study and achieved overall efficacy of 89.7%. The primary endpoint was based on the first occurrence of PCR-confirmed symptomatic (mild, moderate or severe) COVID-19 with onset at least 7 days after the second study vaccination in serologically negative (to SARS-CoV-2) adult participants at baseline. Full results of the trial were published in NEJM.
About Matrix-M™ Adjuvant
Novavax’ patented saponin-based Matrix-M™ adjuvant has demonstrated a potent and well-tolerated effect by stimulating the entry of antigen-presenting cells into the injection site and enhancing antigen presentation in local lymph nodes, boosting immune response.
About Novavax
Novavax, Inc. (Nasdaq: NVAX) is a biotechnology company that promotes improved health globally through the discovery, development and commercialization of innovative vaccines to prevent serious infectious diseases. The company’s proprietary recombinant technology platform harnesses the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles designed to address urgent global health needs. NVX-CoV2373, the company’s COVID-19 vaccine, has received conditional authorization from multiple regulatory authorities globally, including the European Commission and the World Health Organization. The vaccine is also under review by multiple regulatory agencies worldwide. In addition to its COVID-19 vaccine, Novavax is evaluating a COVID-seasonal influenza combination vaccine in a Phase 1/2 clinical trial, which combines NVX-CoV2373 and its quadrivalent influenza investigational vaccine candidate previously known as NanoFlu*. These vaccine candidates incorporate Novavax’ proprietary saponin-based Matrix-M™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies.
For more information, visit www.novavax.com and connect with us on LinkedIn.
*NanoFlu identifies a recombinant hemagglutinin (HA) protein nanoparticle influenza vaccine candidate produced by Novavax. This investigational candidate was evaluated during a controlled phase 3 trial conducted during the 2019-2020 influenza season.
Forward-Looking Statements
Statements herein relating to the future of Novavax, its operating plans and prospects, its partnerships, the timing of clinical trial results, including the PREVENT-19 booster study in adolescents results expected during the second half of 2022, the ongoing development of NVX-CoV2373, including its COVID-19-influenza combination vaccine candidate, the scope, timing and outcome of future regulatory filings and actions, including Novavax’ plans to supplement existing authorizations with data from the additional manufacturing sites in Novavax’ global supply chain, additional worldwide authorizations of NVX-CoV2373, the potential impact and reach of Novavax and NVX-CoV2373 in addressing vaccine access, controlling the pandemic, and protecting populations, and the efficacy, safety and intended utilization of NVX-CoV2373 are forward-looking statements. Novavax cautions that these forward-looking statements are subject to numerous risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include, without limitation, challenges satisfying, alone or together with partners, various safety, efficacy, and product characterization requirements, including those related to process qualification and assay validation, necessary to satisfy applicable regulatory authorities; difficulty obtaining scarce raw materials and supplies; resource constraints, including human capital and manufacturing capacity, on the ability of Novavax to pursue planned regulatory pathways; challenges meeting contractual requirements under agreements with multiple commercial, governmental, and other entities; and those other risk factors identified in the “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” sections of Novavax’ Annual Report on Form 10-K for the year ended December 31, 2021, as filed with the Securities and Exchange Commission (SEC). We caution investors not to place considerable reliance on forward-looking statements contained in this press release. You are encouraged to read our filings with the SEC, available at www.sec.gov and www.novavax.com, for a discussion of these and other risks and uncertainties. The forward-looking statements in this press release speak only as of the date of this document, and we undertake no obligation to update or revise any of the statements. Our business is subject to substantial risks and uncertainties, including those referenced above. Investors, potential investors, and others should give careful consideration to these risks and uncertainties.
Contacts:
Investors
Erika Schultz | 240-268-2022
[email protected]
Media
Ali Chartan | 240-720-7804
Laura Keenan Lindsey | 202-709-7521
[email protected]
“We continue to evaluate the dynamic public health landscape and believe there may be a need for recurrent boosters to fight both COVID-19 and seasonal influenza,” said Gregory M. Glenn, M.D., President of Research and Development, Novavax. “We’re encouraged by these data and the potential path forward for a combination COVID-19-influenza vaccine as well as stand-alone vaccines for influenza and COVID-19.”
The safety and tolerability profile of the combination vaccine was consistent with the stand-alone NVX-CoV2373 and quadrivalent nanoparticle influenza vaccine reference formulations in the trial. The combination vaccine was found to be generally well tolerated. Serious adverse were rare and none were assessed as being related to the vaccine.
The study employed descriptive endpoints, assessing safety and the immunological responses of different CIC vaccine formulations. A Design of Experiments (DOE) modeling-based approach was used to design the trial, enabling more powerful fine-tuning of dose selection of both the COVID-19 and influenza antigens for further development compared to traditional approaches. The preliminary trial results found that various CIC vaccine formulations induced immune responses in participants comparable to reference stand-alone influenza and stand-alone COVID-19 vaccine formulations (for H1N1, H3N2, B-Victoria HA and SARS-CoV-2 rS antigens). Modeling results also showed that a combined formulation has the potential to reduce total antigen amount by up to 50% overall, optimizing production and delivery.
Both protein-based vaccines used in the trial were formulated with the patented saponin-based Matrix-M™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies. These data support advancement to a Phase 2 confirmation trial, expected to begin by the end of 2022.
Data from the trial were presented at the World Vaccine Congress (WVC) in Washington, DC.
At the WVC, Novavax also reviewed key findings from the Phase 3 trial of its stand-alone influenza candidate, previously referred to as NanoFlu, which met its primary immunogenicity endpoint. These results have previously been published in The Lancet.
Neither NVX-CoV2373 or the influenza vaccine candidate have been authorized or approved for use in the U.S. by the U.S. Food and Drug Administration.
- NVX-CoV2373 is contraindicated in persons who have a hypersensitivity to the active substance, or to any of the excipients.
- Events of anaphylaxis have been reported with administration of COVID-19 vaccines. Appropriate medical treatment and supervision should be available in case of an anaphylactic reaction following the administration of the vaccine. Close observation for at least 15 minutes is recommended and a second dose of the vaccine should not be given to those who have experienced anaphylaxis to the first dose of NVX-CoV2373.
- Anxiety-related reactions, including vasovagal reactions (syncope), hyperventilation, or stress‐related reactions may occur in association with vaccination as a psychogenic response to the needle injection. It is important that precautions are in place to avoid injury from fainting.
- Vaccination should be postponed in individuals suffering from an acute severe febrile illness or acute infection. The presence of a minor infection and/or low-grade fever should not delay vaccination.
- NVX-CoV2373 should be given with caution in individuals receiving anticoagulant therapy or those with thrombocytopenia or any coagulation disorder (such as haemophilia) because bleeding or bruising may occur following an intramuscular administration in these individuals.
- The efficacy of NVX-CoV2373 may be lower in immunosuppressed individuals.
- Administration of NVX-CoV2373 in pregnancy should only be considered when the potential benefits outweigh any potential risks for the mother and foetus.
- The effects with NVX-CoV2373 may temporarily affect the ability to drive or use machines.
- Individuals may not be fully protected until 7 days after their second dose. As with all vaccines, vaccination with NVX-CoV2373 may not protect all vaccine recipients.
- The most common adverse reactions observed during clinical studies were headache, nausea or vomiting, myalgia, arthralgia, injection site tenderness/pain, fatigue, and malaise.
For additional safety information, including the full Summary of Product Characteristics with Package Leaflet, please visit www.NovavaxCovidVaccine.com.
The Phase 1/2 CIC vaccine trial is evaluating a combination of Novavax’ recombinant protein-based NVX-CoV2373 and influenza vaccine candidates and patented saponin-based Matrix-M adjuvant in a single formulation. The trial will evaluate the safety, tolerability and immune response to the combination vaccine in 642 healthy adults 50 to 70 years of age. Participants will have been either previously infected with the SARS-CoV-2 virus that causes COVID-19 or vaccinated through an authorized vaccine at least eight weeks prior to enrollment. All participants will be randomly assigned to cohorts to evaluate multiple formulations and will be dosed on Day 0 and again at Day 56. The trial is being conducted in Australia at 10 sites. (ClinicalTrials.gov Identifier: NCT04961541)
NVX-CoV2373 is a protein-based vaccine engineered from the genetic sequence of the first strain of SARS-CoV-2, the virus that causes COVID-19 disease. NVX-CoV2373 was created using Novavax’ recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein and is formulated with Novavax’ patented saponin-based Matrix-M adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies. NVX-CoV2373 contains purified protein antigen and can neither replicate, nor can it cause COVID-19.
Novavax’ COVID-19 vaccine is packaged as a ready-to-use liquid formulation in a vial containing ten doses. The vaccination regimen calls for two 0.5 ml doses (5 mcg antigen and 50 mcg Matrix-M adjuvant) given intramuscularly 21 days apart. The vaccine is stored at 2°- 8° Celsius, enabling the use of existing vaccine supply and cold chain channels. Use of the vaccine should be in accordance with official recommendations.
Novavax has established partnerships for the manufacture, commercialization and distribution of NVX-CoV2373 worldwide. Existing authorizations leverage Novavax’ manufacturing partnership with Serum Institute of India, the world’s largest vaccine manufacturer by volume. They will later be supplemented with data from additional manufacturing sites throughout Novavax’ global supply chain.
Novavax’ patented saponin-based Matrix-M adjuvant has demonstrated a potent and well-tolerated effect by stimulating the entry of antigen-presenting cells into the injection site and enhancing antigen presentation in local lymph nodes, boosting immune response.
Novavax’ influenza vaccine, previously known as NanoFlu, is a quadrivalent recombinant hemagglutinin (HA) protein nanoparticle influenza vaccine produced by Novavax in its SF9 insect cell baculovirus system. The influenza vaccine uses HA amino acid protein sequences that are the same as the recommended wild-type circulating virus HA sequences, and contains Novavax’ patented saponin-based Matrix-M adjuvant. This investigational candidate was evaluated during a controlled phase 3 trial conducted during the 2019-2020 influenza season.
Novavax, Inc. (Nasdaq: NVAX) is a biotechnology company that promotes improved health globally through the discovery, development and commercialization of innovative vaccines to prevent serious infectious diseases. The company’s proprietary recombinant technology platform harnesses the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles designed to address urgent global health needs. NVX-CoV2373, the company’s COVID-19 vaccine, has received conditional authorization from multiple regulatory authorities globally, including the European Commission and the World Health Organization. The vaccine is also under review by multiple regulatory agencies worldwide.
For more information, visit www.novavax.com and connect with us on LinkedIn.
Statements herein relating to the future of Novavax, its operating plans and prospects, its partnerships, the timing of clinical trial results, including the Phase 2 confirmation trial expected to begin by the end of 2022, the ongoing development of NVX-CoV2373, NanoFlu, its COVID-seasonal influenza investigational vaccine candidate, and its COVID-Influenza Combination Vaccine, the scope, timing and outcome of future regulatory filings and actions, including Novavax’ plans to supplement existing authorizations with data from the additional manufacturing sites in Novavax’ global supply chain, additional worldwide authorizations of NVX-CoV2373, the potential impact and reach of Novavax and its COVID-19 Influenza Combination Vaccine in protecting populations, and the efficacy, safety and intended utilization of the COVID-19 Influenza Combination Vaccine, NanoFlu, and NVX-CoV2373 are forward-looking statements. Novavax cautions that these forward-looking statements are subject to numerous risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include, without limitation, challenges satisfying, alone or together with partners, various safety, efficacy, and product characterization requirements, including those related to process qualification and assay validation, necessary to satisfy applicable regulatory authorities; difficulty obtaining scarce raw materials and supplies; resource constraints, including human capital and manufacturing capacity, on the ability of Novavax to pursue planned regulatory pathways; challenges meeting contractual requirements under agreements with multiple commercial, governmental, and other entities; and those other risk factors identified in the “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” sections of Novavax’ Annual Report on Form 10-K for the year ended December 31, 2021, as filed with the Securities and Exchange Commission (SEC). We caution investors not to place considerable reliance on forward-looking statements contained in this press release. You are encouraged to read our filings with the SEC, available at www.sec.gov and www.novavax.com, for a discussion of these and other risks and uncertainties. The forward-looking statements in this press release speak only as of the date of this document, and we undertake no obligation to update or revise any of the statements. Our business is subject to substantial risks and uncertainties, including those referenced above. Investors, potential investors, and others should give careful consideration to these risks and uncertainties.
Contacts:
Investors
Erika Schultz | 240-268-2022
[email protected]
Media
Ali Chartan | 240-720-7804
Laura Keenan Lindsey | 202-709-7521
[email protected]
The Associated Press is reporting that the CDC will now be extending the mask requirement for travel until May 3rd to “allow more time to study the BA.2 omicron subvariant that is now responsible for the vast majority of cases in the U.S.”
Yesterday we reported that residents will no longer be required to wear face coverings when they are passengers on Metro, Metro Bus, Ride-On, and in taxis (including Uber & Lyft) after April 18. That is no longer the case.
According to the CDC, “in order to assess the potential impact the rise of cases has on severe disease, including hospitalizations and deaths, and health care system capacity, the CDC order will remain in place at this time.”
In March, the Transportation Security Administration (TSA), at the request of the CDC, extended its face mask requirement for, “individuals across all transportation networks throughout the United States, including at airports, onboard commercial aircraft, on over-the-road buses, and on commuter bus and rail systems” until April 18. It was originally set to expire on March 18.
The Montgomery County Department of Transportation supplies masks for all riders who don’t have one.
The Associated Press is reporting that the CDC will now be extending the mask requirement for travel until May 3rd to “allow more time to study the BA.2 omicron subvariant that is now responsible for the vast majority of cases in the U.S.”
Yesterday we reported that residents will no longer be required to wear face coverings when they are passengers on Metro, Metro Bus, Ride-On, and in taxis (including Uber & Lyft) after April 18. That is no longer the case.
According to the CDC, “in order to assess the potential impact the rise of cases has on severe disease, including hospitalizations and deaths, and health care system capacity, the CDC order will remain in place at this time.”
In March, the Transportation Security Administration (TSA), at the request of the CDC, extended its face mask requirement for, “individuals across all transportation networks throughout the United States, including at airports, onboard commercial aircraft, on over-the-road buses, and on commuter bus and rail systems” until April 18. It was originally set to expire on March 18.
The Montgomery County Department of Transportation supplies masks for all riders who don’t have one.
All passengers are required to wear face coverings when traveling on @RideOnMCT buses, Flash, @Metrobusinfo @Metrorailinfo Taxis, and On-demand car services until April 18.
😷All MCDOT Ride On buses have a supply of face coverings for those who cannot provide their own😷 pic.twitter.com/HZpB7rsh9x
— MCDOT (@MCDOTNow) April 12, 2022
Need a mask? Don't worry, Ride On has you covered. All of our buses are equipped with free masks for our riders. The federal mask mandate is in place through April 18, 2022. pic.twitter.com/FbO3SVpawr
— Ride On Bus (@RideOnMCT) April 12, 2022
John Hopkins University in Baltimore and Georgetown University in D.C. will both be temporarily reinstating mask mandates due to an increase in COVID-19 cases among students, according to WTOP.
According to the report, the indoor mask requirement goes into effect today, April 7, on the Main and Medical Center campuses at Georgetown.
At Johns Hopkins, masks will be required in all classrooms, as well as in common areas of residence and dining halls.
Georgetown students will also need to take a PCR test after Easter break the week of April 18, unless they have tested positive within the previous 90 days.
John Hopkins will be moving to twice-weekly testing for all undergraduate students for at least this week and the next two weeks (through April 22). The school will then re-evaluate and determine whether the increased testing remains necessary.
Full statements from Georgetown University and John Hopkins below:
Georgetown University:
We are temporarily reinstating an indoor mask requirement for the Main and Medical Center campuses, beginning Thursday, April 7. Please also see information below regarding COVID-19 testing and isolation procedures for undergraduate students.
We are taking these steps in response to a significant increase in COVID-19 cases on the Main Campus and Medical Center campuses this week, particularly among undergraduate students. We have not seen a comparable increase in cases on the Law Center campus. Thankfully, with the vast majority of our community up to date on vaccination, we are not seeing cases involving severe illness.
This increase is partly due to the impact of the BA.2 Omicron subvariant. BA.2 is now the dominant strain in the United States, including in DC and on our campuses. While recent studies show that BA.2 does not cause more severe illness than the initial Omicron variant, they also show that BA.2 is even more transmissible.
These circumstances present a challenge, but we have learned to adjust our mitigation measures to respond to changing conditions throughout the pandemic. Another adjustment is needed now to curb transmission on campus.
Temporary Reinstatement of Indoor Mask Requirement
Beginning Thursday, April 7, everyone will need to wear a mask indoors on the Main and Medical Center campuses, except when in their personal residence or private office or while actively eating or drinking. This requirement will be in effect until further notice.
We strongly recommend wearing a properly-fitting, high-quality mask (e.g., N95, KN95), which are available for free on campus. We also strongly recommend that all members of our community wear a mask when attending indoor social gatherings and events off campus as well.
In the March 18 message, we shared that the University’s mask-optional policy is contingent on public health conditions and that we may need to reinstate the indoor mask requirement or other restrictions for short periods.
We will continue to monitor campus case numbers and positivity rates, COVID-19 community levels in DC and nationally, and global developments relating to the pandemic, which will inform our decision of when to resume the mask-optional policy.
COVID-19 Testing
All undergraduate students will need to take a PCR test after Easter break the week of April 18, unless they have tested positive within the previous 90 days. Please schedule your test in advance via the One Medical app or website. If you get tested through a third-party provider (i.e., not One Medical), please report your result through the COVID-19 Test Result Submission form.
If you have been exposed to anyone with a known COVID-19 infection, please get tested on day 5 following your exposure.
Please also get tested when selected to participate in the University’s random asymptomatic testing.
Isolation Procedures for Undergraduate Students
We are nearing full capacity at our campus hotel and have secured additional isolation space at a nearby hotel.
Residential students who test positive may need to share a hotel room or isolate in their campus residence, which means that COVID-positive and negative students may need to be housed together in the same room or apartment.
Students who test positive who prefer to isolate at home may travel home by private transportation, wearing a properly-fitting, high-quality mask (e.g., N95, KN95) while in a vehicle with others, but should not travel home by public transportation (e.g., plane, train, ride-share).
Symptom Monitoring
As a reminder, please stay home if you have symptoms of COVID-19, except to get tested, and report them to the Public Health team by completing the COVID-19 Symptom Check-In survey.
Dining and Events
We encourage grab-and-go dining and eating in the outdoor tents on campus, whenever possible. Events may continue as planned.
We’ve developed the frequently asked questions below to provide additional information, which we hope you will find helpful.
As we’ve done multiple times before, we will get through this surge together and continue to thrive despite these short-term restrictions.
Sincerely,
Ranit Mishori, M.D., MHS, FAAFP
Professor of Family Medicine, Vice President and Chief Public Health Officer
John Hopkins University:
Dear Undergraduate Students,
Since Spring Break, we have received reports of COVID cases among undergraduates who have recently traveled or who were exposed to someone who has recently traveled. Nearly 100 undergraduate students have reported a positive test since April 1, with cases evenly split among residential and non-residential students. Consistent with what we have seen this term, many students who tested positive are asymptomatic, and the rest are experiencing only mild symptoms.
To help monitor the situation, we are moving to twice-weekly testing for all undergraduate students for at least this week and the next two weeks (through April 22). We will then re-evaluate and determine whether the increased testing remains necessary. We are also temporarily reinstating masking requirements for all people (students, staff, faculty, contractors, visitors, and guests) in common areas of the residence halls and in university dining facilities, except when actively eating or drinking. This is in addition to the required masking in classrooms. The university will continue to provide free, high-quality masks at asymptomatic testing sites.
In order to effectively manage our inventory of off-campus isolation housing, we may also adopt the isolation-in-place protocols outlined in a January message for residential undergraduates. In that case, we would prioritize off-campus isolation housing for residential students most in need, such as those with medical conditions that place them at higher risk from COVID; those who are experiencing more serious presentations of COVID; or those whose living arrangements may make it difficult to isolate (such as students living in doubles as opposed to suites with individual bedrooms). We currently are not accommodating our off-campus COVID-positive students in university isolation housing. However, they should continue to use the resources of Student Health and Wellness and Student Outreach and Support.
If students are asked to isolate in place, they must remain in their rooms and are not to leave unless there is a building or medical emergency. They will have meals delivered to their door, and mail, laundry, and trash removal services will be made available. Isolating students – whether in their rooms or in off-campus housing — are also instructed to communicate with their professors and create plans for handling absences from classes, assignments, and exams.
A member of the COVID Support Team will reach out to you as a follow up to answer any questions or concerns you may have about the isolation process and resources available to you.
We want to assure you that we are taking these precautions so that other students in the university’s residence hall buildings are not put at risk. To help students monitor their own health, we are making self-tests available to all residential students. These tests supplement, but do not replace, the mandatory asymptomatic saliva testing requirements that are in place. Test kits can be picked upfrom 1:30 to 4:30 p.m., Monday through Friday, in the Wolman Housing Office or AMR II Residential Life office.
We appreciate your continued flexibility and will provide to updates as conditions warrant.
Sincerely,
Kevin Shollenberger
Vice Provost for Student Health and Well-Being
The Montgomery County Department of Health and Human Services announced that it has received written guidance from the Maryland Department of Health and will begin offering second COVID-19 boosters at Montgomery County clinics beginning today, March 30.
Per Montgomery County:
Eligible people
Effective March 30, 2022, our County-run clinics provide second COVID-19 booster shots as recommended by the FDA and CDC.
If you are 18 years and older, you may choose any of the available COVID-19 vaccines as your booster. If you want a specific vaccine as your booster, check that your vaccination site has it available.
12 to 17-year-olds must select Pfizer boosters.
| If you got | You can get a booster | If you are |
|---|---|---|
| Pfizer | 5 months after second dose | 12 years and older |
| Moderna | 5 months after second dose | 18 years and older |
| Johnson & Johnson | 2 months after single dose |
If you immunocompromised and ages 12 to 17, you may get a second booster of Pfizer vaccine at least 4 months after your first booster.
If you are 50 years and older, or immunocompromised and 18 years and older, you may get a second booster of Moderna or Pfizer vaccine at least 4 months after your first booster.
| If you got | An additional dose of Moderna or Pfizer is recommended | You can get a Moderna or Pfizer booster | If you are |
|---|---|---|---|
| Pfizer | At least 28 days after your second dose | at least 3 months after third dose (ages 12 to 17: Pfizer only) | Immunocompromised and 12 years and older |
| Moderna | At least 28 days after your second dose | at least 3 months after third dose | Immunocompromised and 18 years and older |
| Johnson & Johnson | At least 28 days after your first dose | At least 2 months after second dose |
UPDATED: We have received written guidance from @MDHealthDept and our clinics will offer second boosters to those who are eligible TODAY. https://t.co/DlRypM1C5Y
— Montgomery County DHHS (@MoCoDHHS) March 30, 2022
- U.S. NIAID-sponsored trial will evaluate heterologous booster regimens, including NVX-CoV2373, after primary series with current FDA approved or emergency use authorized-vaccines
- NVX-CoV2373 will be evaluated in a head-to-head boosting trial in the United Arab Emirates to assess boosting options for a large number of the world’s population that have previously been vaccinated with inactivated COVID-19 vaccine
GAITHERSBURG, Md., March 25, 2022/PRNewswire/ — Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, today announced that NVX-CoV2373, its protein-based COVID-19 vaccine, is included in two trials now underway to evaluate its vaccine’s safety, immunogenicity, and reactogenicity as a booster amidst the ongoing COVID-19 pandemic. Both studies have initiated participant enrollment and will help to extend knowledge of how a range of vaccines, including Novavax’ COVID-19 vaccine, can be used as boosters following primary immunization.
“Additional COVID-19 booster studies are important to support vaccine choice for individuals, healthcare providers, and public health authorities,” said Filip Dubovsky, M.D., Chief Medical Officer, Novavax. “Our COVID-19 vaccine has already been recommended by multiple national policy bodies for both primary vaccination and booster settings in individuals 18 years of age and older. We look forward to adding to this body of evidence to support the expanded use of our protein-based vaccine.”
Novavax is participating in an ongoing Phase 1/2 trial sponsored by the National Institute of Allergy and Infectious Diseases (NIAID) to assess homologous and heterologous boosting regimens in participants who received a primary series of a COVID-19 vaccine which has received full approval or Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA). Participants will be given a third dose (> 12 weeks later) of either NVX-CoV2373 or one of the three COVID-19 vaccines that have already received EUA or full authorization from the FDA. The study is enrolling approximately 1,130 healthy individuals aged 18 years or older, about 180 of whom will receive NVX-CoV2373 as a heterologous booster. The trial is being conducted at approximately 10 clinical research sites and its primary objectives are to evaluate safety, reactogenicity, and immunogenicity of delayed heterologous or homologous vaccine doses after EUA dosed vaccines. Participants will be followed for 12 months, with topline results expected later this year and full results expected in 2023.
Novavax’ COVID-19 vaccine is also being evaluated in an observer-blinded Phase 3 study in the United Arab Emirates (UAE) to assess homologous versus heterologous boosting of participants who have already been immunized with Sinopharm’s COVID-19 vaccine. The safety and immunogenicity of a single booster dose of Novavax’ COVID-19 vaccine in adults previously vaccinated with Sinopharm’s COVID-19 vaccine will be evaluated. The study is enrolling approximately 1,000 participants aged 18 years or older at two centers in Abu Dhabi with the goal of providing data to support boosting with NVX-CoV2373 in the large number of individuals who have been vaccinated with inactivated vaccines globally. Participants will be followed for six months, with full results expected during the fourth quarter of 2022. The Ministry of Health and Prevention approved NVX-CoV2373 for emergency use in the UAE in December.
For more information about the NIAID-sponsored study, read here on clinicaltrials.gov. For more information about the study in the UAE, read here on clinicaltrials.gov. NVX-CoV2373 has not yet been authorized for use by the FDA, nor has it received heterologous or homologous booster approval in all the countries where it’s been authorized.
- NVX-CoV2373 is contraindicated in persons who have a hypersensitivity to the active substance, or to any of the excipients.
- Events of anaphylaxis have been reported with administration of COVID-19 vaccines. Appropriate medical treatment and supervision should be available in case of an anaphylactic reaction following the administration of the vaccine. Close observation for at least 15 minutes is recommended and a second dose of the vaccine should not be given to those who have experienced anaphylaxis to the first dose of NVX-CoV2373.
- Anxiety-related reactions, including vasovagal reactions (syncope), hyperventilation, or stress‐related reactions may occur in association with vaccination as a psychogenic response to the needle injection. It is important that precautions are in place to avoid injury from fainting.
- Vaccination should be postponed in individuals suffering from an acute severe febrile illness or acute infection. The presence of a minor infection and/or low-grade fever should not delay vaccination.
- NVX-CoV2373 should be given with caution in individuals receiving anticoagulant therapy or those with thrombocytopenia or any coagulation disorder (such as haemophilia) because bleeding or bruising may occur following an intramuscular administration in these individuals.
- The efficacy of NVX-CoV2373 may be lower in immunosuppressed individuals.
- Administration of NVX-CoV2373 in pregnancy should only be considered when the potential benefits outweigh any potential risks for the mother and foetus.
- The effects with NVX-CoV2373 may temporarily affect the ability to drive or use machines.
- Individuals may not be fully protected until 7 days after their second dose. As with all vaccines, vaccination with NVX-CoV2373 may not protect all vaccine recipients.
- The most common adverse reactions observed during clinical studies were headache, nausea or vomiting, myalgia, arthralgia, injection site tenderness/pain, fatigue, and malaise.
NVX-CoV2373 is a protein-based vaccine engineered from the genetic sequence of the first strain of SARS-CoV-2, the virus that causes COVID-19 disease. NVX-CoV2373 was created using Novavax’ recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein and is formulated with Novavax’ patented saponin-based Matrix-M™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies. NVX-CoV2373 contains purified protein antigen and can neither replicate, nor can it cause COVID-19.
Novavax’ COVID-19 vaccine is packaged as a ready-to-use liquid formulation in a vial containing ten doses. The vaccination regimen calls for two 0.5 ml doses (5 mcg antigen and 50 mcg Matrix-M adjuvant) given intramuscularly 21 days apart. The vaccine is stored at 2°- 8° Celsius, enabling the use of existing vaccine supply and cold chain channels. Use of the vaccine should be in accordance with official recommendations.
Novavax has established partnerships for the manufacture, commercialization and distribution of NVX-CoV2373 worldwide. Existing authorizations leverage Novavax’ manufacturing partnership with Serum Institute of India (SII), the world’s largest vaccine manufacturer by volume. They will later be supplemented with data from additional manufacturing sites throughout Novavax’ global supply chain.
NVX-CoV2373 is being evaluated in two pivotal Phase 3 trials.
PREVENT-19, a trial in the U.S. and Mexico that enrolled almost 30,000 participants aged 18 years and older, achieved 90.4% efficacy overall. It was designed as a 2:1 randomized, placebo-controlled, observer-blinded study to evaluate the efficacy, safety and immunogenicity of NVX-CoV2373. The primary endpoint for PREVENT-19 was the first occurrence of PCR-confirmed symptomatic (mild, moderate or severe) COVID-19 with onset at least 7 days after the second dose in serologically negative (to SARS-CoV-2) adult participants at baseline. The statistical success criterion included a lower bound of 95% CI >30%. A secondary endpoint was the prevention of PCR-confirmed, symptomatic moderate or severe COVID-19. Both endpoints were assessed at least seven days after the second study vaccination in volunteers who had not been previously infected with SARS-CoV-2. It was generally well-tolerated and elicited a robust antibody response after the second dose in both studies. Full results of the trial were published in the New England Journal of Medicine (NEJM).
A trial conducted in the U.K. with 14,039 participants aged 18 years and older was designed as a randomized, placebo-controlled, observer-blinded study and achieved overall efficacy of 89.7%. The primary endpoint was based on the first occurrence of PCR-confirmed symptomatic (mild, moderate or severe) COVID-19 with onset at least 7 days after the second study vaccination in serologically negative (to SARS-CoV-2) adult participants at baseline. Full results of the trial were published in NEJM.
Novavax’ patented saponin-based Matrix-M™ adjuvant has demonstrated a potent and well-tolerated effect by stimulating the entry of antigen-presenting cells into the injection site and enhancing antigen presentation in local lymph nodes, boosting immune response.
Novavax, Inc. (Nasdaq: NVAX) is a biotechnology company that promotes improved health globally through the discovery, development and commercialization of innovative vaccines to prevent serious infectious diseases. The company’s proprietary recombinant technology platform harnesses the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles designed to address urgent global health needs. NVX-CoV2373, the company’s COVID-19 vaccine, has received conditional authorization from multiple regulatory authorities globally, including the European Commission and the World Health Organization. The vaccine is also under review by multiple regulatory agencies worldwide. In addition to its COVID-19 vaccine, Novavax is also currently evaluating a COVID-seasonal influenza combination vaccine in a Phase 1/2 clinical trial, which combines NVX-CoV2373 and NanoFlu, its quadrivalent influenza investigational vaccine candidate. These vaccine candidates incorporate Novavax’ proprietary saponin-based Matrix-M™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies.
For more information, visit www.novavax.comand connect with us on Twitter, LinkedIn, Instagram and Facebook.
Statements herein relating to the future of Novavax, its operating plans and prospects, its partnerships, the timing of clinical trial results, the ongoing development of NVX-CoV2373 and NanoFlu, its COVID-seasonal influenza investigational vaccine candidate, the scope, timing and outcome of future regulatory filings and actions, including Novavax’ plans to supplement existing authorizations with data from the additional manufacturing sites in Novavax’ global supply chain, the potential impact and reach of Novavax and NVX-CoV2373 in addressing vaccine access, controlling the pandemic and protecting populations, and the efficacy, safety and intended utilization of NVX-CoV2373 are forward-looking statements. Novavax cautions that these forward-looking statements are subject to numerous risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include, without limitation, challenges satisfying, alone or together with partners, various safety, efficacy, and product characterization requirements, including those related to process qualification and assay validation, necessary to satisfy applicable regulatory authorities; difficulty obtaining scarce raw materials and supplies; resource constraints, including human capital and manufacturing capacity, on the ability of Novavax to pursue planned regulatory pathways; challenges meeting contractual requirements under agreements with multiple commercial, governmental, and other entities; and those other risk factors identified in the “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” sections of Novavax’ Annual Report on Form 10-K for the year ended December 31, 2021, as filed with the Securities and Exchange Commission (SEC). We caution investors not to place considerable reliance on forward-looking statements contained in this press release. You are encouraged to read our filings with the SEC, available at www.sec.govand www.novavax.com, for a discussion of these and other risks and uncertainties. The forward-looking statements in this press release speak only as of the date of this document, and we undertake no obligation to update or revise any of the statements. Our business is subject to substantial risks and uncertainties, including those referenced above. Investors, potential investors, and others should give careful consideration to these risks and uncertainties.
Contacts:
Investors
Novavax, Inc.
Erika Schultz | 240-268-2022
[email protected]
Solebury Trout
Alexandra Roy | 617-221-9197
[email protected]
Media
Ali Chartan | 240-720-7804
Laura Keenan Lindsey | 202-709-7521
[email protected]
SOURCE Novavax, Inc.
The Montgomery County Council will hold its first in-person meeting in over two years tomorrow, March 15. Council President Gave Albornoz announced today that proof of COVID-19 vaccination will no longer be required to attended.
At today’s media availability, Albornoz said, “upon further reflection and consultation, we’ve decided to not have that be a requirement, to maintain consistency and access to all of our various county facilities, but we do strongly recommend that people do continue to be vaccinated. It has undeniably been the best tool and resource in our fight against COVID-19.”
Residents that do not wish to testify in person can also provide prerecorded audio or video testimony to the Council or submit written testimony.
You can view the agenda for tomorrow’s council meeting here.
Albornoz had previously announced on March 1 that attendees of the meetings will have to show proof of vaccination before entering. At the time, Albornoz told WTOP, “I think the optics are not negative; I think they are positive. We want to encourage county residents to have their vaccinations, and fortunately, over 90% of county residents are vaccinated,” when asked if a government agency placing restrictions on attendance to a public meeting could cause bad optics.
You can view today’s media availability on the council’s Facebook page:
https://www.facebook.com/MontgomeryCountyMdCouncil/videos/507813750965756/
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Per the City of Takoma Park:
Recently, the CDC has shifted its focus from community transmission to community levels as the basis for their guidance regarding recommended COVID-19 preventative measures. Montgomery County currently has a “low” community level as of this past Monday, March 7. The City of Takoma Park will be adjusting our protocols and lifting our mask mandate.
Effective Wednesday, March 9th, masks are not required indoors but strongly encouraged for any unvaccinated visitors in any City buildings or facilities, where social distancing is challenging, and/or when there is direct interaction between the public and employees.
As safety and health remain our #1 priority, the City of Takoma Park will continue to have KN95/N95 masks and rapid test kits available for the public and employees as necessary. We will continue to monitor the community levels and will be prepared to shift our protocols when appropriate.
Per MCPS:
During its March 8 business meeting, the Montgomery County Board of Education voted to make masks optional in all MCPS schools and facilities. This new guidance goes into effect immediately.
This action follows the state of Maryland’s decision to end its statewide mask mandate in schools and aligns with revised Centers for Disease Control and Prevention (CDC) guidelines that no longer recommend universal mask-wearing in schools.
To maintain the safety of our staff and students, other COVID-19 mitigation strategies will continue, including in-school rapid and random testing, distribution of take-home test kits, improved HVAC systems and vaccination availability. Mask-wearing in MCPS will become optional indoors, outside and on school buses. Anyone who chooses to wear a mask may continue to do so, and your child may request a mask from their school if they want one.
Masks: On or Off, It is Just Me
While some will welcome the new mask policy, others may worry about the change. There will be students, teachers and administrators who wish to continue to mask in our schools. We must respect that. So, On or Off, It’s Just Me is a reminder that wearing masks may be an individual choice and we must respect each other’s choices.
As a district, we expect our MCPS community to respect individual decisions about mask-wearing at this time. Our staff and students must model kindness, acceptance and inclusivity. MCPS will work with students, staff and families to promote a shared understanding of respecting each individual’s decision as valid.
MCPS will promote acceptance of masking choices by sharing this important message in posters, flyers, video public service announcements, community messages and through social media. Resources will be provided to schools to include in their own communications with students and families.
Parent Resources
Surprise: Students May be Nervous About Ditching the Mask
How to Deal with Bullying Over Face Masks
MCPS Form to Report Bullying and Harassment
MCPS Bullying and Harassment Information
Important Reminder: If you are sick, stay home. Any student or staff member who has COVID-19 like symptoms should remain home. Symptomatic individuals can only return to schools if free from COVID-19 symptoms, including fever of 100.4 or more, sore throat, cough, difficulty breathing, diarrhea, vomiting, and loss of taste or smell. Use this daily health checklist to help you determine if you are healthy enough to come to school and work.
Quarantine and Isolation Guidelines Remain the Same
Current guidelines governing quarantine and isolation for both students and staff for positive COVID-19 cases have not changed. The policy is five days if certain health conditions are met. This aligns with the recommendations of the CDC, the Maryland Department of Health and the Montgomery County Department of Health and Human Services.
Learn more here https://www.montgomeryschoolsmd.org/coronavirus/quarantine.aspx
Vaccination
As a reminder, vaccination is the best tool to fight COVID-19 and keep our schools safe for all our students. Children ages 5 and older are eligible to be vaccinated against COVID-19. If your child is eligible but not yet vaccinated against COVID-19, you can find out how here https://www.montgomeryschoolsmd.org/Coronavirus/Vaccinations/
Montgomery County Public Schools will continue to closely monitor COVID-19 data from the CDC, in collaboration with the Montgomery County Department of Health and Human Services, and revisit the issue of masks in school buildings, facilities and on school buses, if needed.
Per Montgomery County:
For Immediate Release: Monday, March 7, 2022
Montgomery County’s month of recognizing and commemorating two years of fighting the COVID-19 pandemic continues this week with “Public Health and Health Care Week” (March 6 – 12). The County is highlighting the sacrifices, dedication and efforts of individuals and partners in the community as we continue to move forward.
The monthlong commemoration began with “Memorial Week,” a remembrance of the lives lost to COVID-19 in Montgomery County and the sharing of stories, with #MoCoRemembers, including those of County government employees who lost their lives, culminating with a candlelight vigil on March 3. As the fight against the virus continues, the County continues to remember those who have died from COVID-19 and recognize the many residents and organizations who helped save lives over the last two years. For more information about the monthlong event, visit the County’s website.
“The pandemic is like nothing any of us has experienced in our lifetime,” said Dr. Raymond Crowel, director of the County’s Department of Health and Human Services (DHHS). “While we as a community mourn the loss of nearly 2,000 of our neighbors, we also want to recognize and appreciate the work of so many who have helped save and protect lives throughout the past two years.”
Public Health Services, a division of DHHS, has been at the forefront of the County’s response to the COVID-19 pandemic, as well as countless other health care professionals, the six hospitals in the community, and organizations and human service providers who have worked to keep the community safe, protect lives and meet the needs of everyone impacted. DHHS, the County’s largest department, has been at the center of fighting the pandemic and responding to the unprecedented needs of the community, including food and financial assistance, as well as mental health support and other vital services.
Look for social media postings on DHHS’ Twitter and Facebook throughout the week honoring those who have worked tirelessly in the past two years.
