Reddit and its partners use cookies and similar technologies to provide you with a better experience. Novavax' COVID-19 vaccine is authorized for use as an adult booster in more than 35 countries, and a number of other countries have policy recommendations allowing use of the vaccine as a booster . "I'm making a personal choice based on my own research and my own body," he says. If approved, it would be the first protein-based vaccine to be recommended by the WHO. To maximize our opportunities and mitigate the significant risks and uncertainties of the COVID-19 market, our goal is to reduce spend, extend our cash runway and operate efficiently to best position the company to deliver long-term growth. Jobs could come alongside the new jab, too: in March, Boris Johnson announced that 60m doses would be made in north-east England. A webcast of the conference call can also be accessed on the Novavax website at novavax.com/events. Novavax began developing its COVID vaccine in 2020 with government funding, but its vaccine did not receive final emergency-use approval until July 2022, well after mRNA vaccines from Pfizer and Moderna had dominated the market for COVID vaccines. NEWS ALERT: Lesion removed from Bidens chest was cancerous; no further treatment required, Jeff Clabaugh | jclabaugh@wtop.com. Gaithersburg, Maryland-based Novavax, whose protein-based COVID-19 vaccine was a latecomer to the market, lost as much as a quarter of its value Wednesday, after the company warned of substantial doubt about its ability to stay in business. [44] In 2020 it was reported, that the vaccine would be manufactured in Spain[45] and in November 2021 it was reported to be produced in Poland by the Mabion company. Novavax has further delayed the submission of data for its Covid-19 vaccine to the US regulator as the biotechnology company continues to struggle with collating consistent manufacturing . Can Nigeria's election result be overturned? The vaccine contains the SARS-CoV-2 spike protein and Matrix-M adjuvant. Its a testament to the countrys first-rate research and development capabilities for vaccines with tens of thousands of people taking part in clinical trials here in the UK, contributing to the invaluable research that shows our vaccines are safe and effective. Lower reactogenicity becomes particularly important in groups such as children, where the balance between vaccination and not vaccination becomes a little less clear, simply because, for example, in young children the likelihood of them having severe Covid-19 is so small, said Prof Paul Heath, the director of the Vaccine Institute at St Georges, University of London, and chief investigator of Novavaxs UK trial. Even so, that was on the low end of the companys revised forecast issued last summer, and half its previous forecast for 2022 revenue. SAGE will update this advice as information on the impact of vaccination on virus transmission and indirect protection is assessed. On 4 November, the company submitted an emergency use application to the World Health Organization. By Berkeley Lovelace Jr. [27], In December 2021, Novavax reported that its phase III trial showed the vaccine achieved its primary endpoint of preventing infection at least seven days after the second dose. 3 February 2022 Nuvaxovid, the COVID-19 vaccine developed by Novavax, has today been given regulatory approval by the Medicines and Healthcare products Regulatory Agency (MHRA). The vaccine effectiveness reached 80% for this population. [88][89] As of December 2021 it was validated by the World Health Organization. On 23 July 2021, the TGA approved the Pfizer COVID-19 vaccine for teenagers between 12 and 15 years old. I want the UK to be the best place in the world to conduct clinical trials. The wait to make the Novavax jab available comes after the UK played a significant part in its development: government-funding helped support clinical trials and 15,000 British volunteers participated in the testing. Even lifting it [vaccination rates] by a few per cent would be worth it.". Given these uncertainties, substantial doubt exists regarding our ability to continue as a going concern through one year from the date that these financial statements are issued. 8 June 2022 by Alexis Jones. Late last month the US company, with a factory on Teesside primed to manufacture doses, submitted final data to UK regulators and a positive decision is anticipated within days or weeks. Both the Pfizer and Moderna jabs have been tested on a cross-section of the population, including people with a variety of health conditions. "It's been so frustrating - and it's not just me," says a woman in her 40s, who did not want to be named. On 13 July 2022, the FDA authorized NVX-CoV2373 for emergency use as a primary immunization (not booster) in adults. of COVID-19 in pregnancy, the likely benefits of vaccination in the local epidemiological context, and the current limitations of safety data in pregnant persons. [96], "Covovax" redirects here. Check benefits and financial support you can get, Find out about the Energy Bills Support Scheme, Medicines and Healthcare products Regulatory Agency, European Commission (EC) Decision Reliance Route, The Medicines and Healthcare products Regulatory Agency, Pfizer/BioNTech COVID-19 vaccine shelf-life extended from 5 to 31 days, says MHRA, Commission on Human Medicines advice on ibuprofen and coronavirus (COVID-19), MHRA response to JCVI advice on COVID-19 Vaccine AstraZeneca for people aged under 40, UK regulator confirms that people should continue to receive the COVID-19 vaccine AstraZeneca, Report of the Commission on Human Medicines Expert Working Group on Optimising Data on Medicines used During Pregnancy. Nuvaxovid is distinct from other COVID-19 vaccines currently in use in the UK as it uses recombinant protein-based technology which has been used for many years in the development of vaccines to prevent other illnesses, for example Hepatitis B. All rights reserved. Novavax will host its quarterly conference call today at 4:30 p.m. Novavax has received the largest US government award for developing a coronavirus vaccine to-date. [73], About 216,000 doses of the Novavax COVID-19 vaccine were administered in the EU/EEA from authorization to 26 June 2022. He said: The AstraZeneca vaccine has similar storage requirements to Novavax but the UK government seems to have largely stopped using it.. [66], On 28 January 2021, Novavax reported that preliminary results from the United Kingdom trial showed that its vaccine candidate was more than 89% effective. Meanwhile, Novavax got its first approval anywhere in the world on Monday, when the company and partner Serum received emergency-use authorization for their COVID-19 vaccine in Indonesia. The vaccine is already available for use in at least 170 countries, but if . [5] In November 2021, the EMA received application for conditional marketing authorization. The WHO EUL process also evaluates the quality of manufacturing along with safety and efficacy. Coalition for Epidemic Preparedness Innovations, Full list of Novavax vaccine authorizations, List of COVID-19 vaccine authorizations Novavax, Centers for Disease Control and Prevention, Advisory Committee on Immunization Practices, "WHO issues emergency use listing to Novavax-Serum Institute's COVID-19 vaccine", "Regulatory approval of COVID-19 vaccine Nuvaxovid", Medicines and Healthcare products Regulatory Agency, "EMA starts rolling review of Novavax's COVID-19 vaccine (NVX-CoV2373)", "Novavax and Takeda Finalize License Agreement for Novavax' COVID-19 Vaccine Candidate in Japan; Takeda Initiates Phase 1/2 Trial in Japan", "SARS-CoV-2 rS (NVX-CoV-2373) vaccine for prevention of COVID-19", "Updates to the Prescribing Medicines in Pregnancy database", "TGA eBS - Product and Consumer Medicine Information Licence", "AusPAR: SARS-CoV-2 rS with Matrix-M adjuvant", "AusPAR: SARS-CoV-2 rS vaccine with Matrix-M1 adjuvant", "Product Monograph, NUVAXOVID , COVID-19 Vaccine (Recombinant protein, Adjuvanted)", "Summary Basis of Decision (SBD) for Nuvaxovid", "Novavax COVID-19 Vaccine: Standing Orders for Administering Vaccine to Persons 12 Years of Age and Older", "Coronavirus (COVID-19) Update: FDA Authorizes Emergency Use of Novavax COVID-19 Vaccine, Adjuvanted", "Hope to launch Covovax by September, says Serum Institute CEO", "COVID-19 vaccine trials should seek worthwhile efficacy", "Neutralizing antibody levels are highly predictive of immune protection from symptomatic SARS-CoV-2 infection", "Efficacy and Safety of NVX-CoV2373 in Adults in the United States and Mexico", "A fourth Covid vaccine is cleared for use in the United States", "Safety and Efficacy of NVX-CoV2373 Covid-19 Vaccine", "Efficacy of NVX-CoV2373 Covid-19 Vaccine against the B.1.351 Variant", "COVID-19 vaccine safety report - 27-01-2023", "Novavax vaccine delivers 89% efficacy against COVID-19 in UK but is less potent in South Africa", "New Covid vaccine shows 89% efficacy in UK trials", "Novavax launches pivotal U.S. trial of dark horse COVID-19 vaccine after manufacturing delays", "COVID-19 Vaccine Frontrunners and Their Nanotechnology Design", "Selective Naked-Eye Detection of SARS-CoV-2 Mediated by N Gene Targeted Antisense Oligonucleotide Capped Plasmonic Nanoparticles", "Urgent global health needs addressed by Novavax", "Researchers Are Hatching a Low-Cost Coronavirus Vaccine", "Takeda Provides Updates on Phase 1/2 Clinical Trials of Novavax' and Moderna's COVID-19 Vaccine Candidates in Japan", "Novavax signs COVID-19 vaccine supply deal with India's Serum Institute", "Spain, again chosen to produce the vaccine to combat COVID-19", "Novavax Deal With Mabion Boosts Poland's Nascent Biotech Scene", "EU approves Novavax shot as fifth COVID vaccine", "SII begins manufacturing, stockpiling 2nd Covid vaccine Covovax after Modi govt nod", "Novavax is working to advance a potential coronavirus vaccine. In reaching its decision, the MHRA considered the results of 2 large clinical trials involving nearly 50,000 participants. In reaching this decision, we have taken advice from the governments independent scientific advisory body, the Commission on Human Medicines. WHO recommends the use of the Novavax (NVX-CoV2373) vaccine in pregnant persons when the benefits of vaccination to the pregnant persons outweigh the potential risks. Worldwide, the more vaccines the better, particularly if they are low cost and dont require freezing for storage and delivery, said Brendan Wren, professor of microbial pathogenesis at the London School of Hygiene and Tropical Medicine. Primary and secondary objectives of the study are to assess the safety, tolerability, and immune responses to various formulations of the CIC and influenza vaccine candidates. had been approved by a trusted foreign regulatory authority. The . The vaccination regimen calls for two 0.5 ml doses (5 microgram antigen and 50 microgram Matrix-M adjuvant) given intramuscularly 21 days apart. Novavax's COVID-19 vaccine has cleared the Food and Drug Administration's (FDA) vaccine advisory committee, but. Trial data appear to show the potential for lower reactogenicity compared with existing jabs, meaning side-effects such as injection-site swelling, fatigue, headaches and muscle pain occur less frequently. is compromised, these recommendations will be updated accordingly. This extension has been. The Novavax COVID-19 vaccine, sold under the brand names Nuvaxovid and Covovax,[1] among others, is a subunit COVID-19 vaccine developed by Novavax and the Coalition for Epidemic Preparedness Innovations (CEPI). Novavax has a version of its vaccine specific for the Beta variant of concern in preclinical investigations. Because of Novavaxs simpler storage requirements, it would be easier to use in GP surgeries and pharmacies, said Majeed. Individuals with a history of anaphylaxis to any component of the vaccine should not take it. The efficacy of Novavax (NVX-CoV2373) has been assessed in three Phase 2 and Phase 3 trials. The vaccine is stored at 2- 8 Celsius, enabling the use of existing vaccine supply and . To help pregnant women make this assessment, they should be provided with information about the risks [33], The vaccine requires two doses[34] and is stable at 2 to 8C (36 to 46F) refrigerated temperatures. *Included in current and noncurrent liabilities as of December 31, 2022 and non-current liabilities as of December 31, 2021. Australia's first human trials of a candidate COVID-19 vaccine was Novavax's NVX-CoV2373 which began in Melbourne by 26 May 2020. But they are based on a newer type of technology which delivers genetic code, known as messenger RNA (mRNA), into the bodies' cells - instructing them to produce copies of the distinctive spike protein found on the surface of the SARS-CoV-2 virus. To access the replay by telephone, dial (877) 344-7529 (Domestic) or (412) 317-0088 (International) and use passcode 1137418. [25], The Novavax COVID19 vaccine is indicated for active immunization to prevent COVID19 caused by SARS-CoV-2. When added to vaccines, Novavax's patented saponin-based Matrix-M adjuvant enhances the immune system response, making it broader, and more durable. The goal suggests the U.S. could join the U.K. on the list of countries to authorize the vaccine in the . The Conditional Marketing Authorisation (CMA) extension granted by the MHRA is valid in Great Britain only and was approved via the European Commission (EC) Decision Reliance Route. Emerging post-introduction pharmacovigilance data relating to the use of NVX-CoV2373 in pregnant women have not identified any pregnancy-related safety concerns and based on previous evidence from other protein-based vaccines during pregnancy, efficacy is expected to be comparable to The vaccine is packaged as a ready-to-use liquid formulation and is stored at 2 to 8C, enabling the use of existing vaccine supply and cold chain channels. An 8-week interval is recommended between primary series doses of NVX-CoV2373. The Pfizer-BioNTech vaccine (brand name: Comirnaty) was granted full Food and Drug Administration (FDA) approval in August 2021 for people ages 16 and older. A first dose of the Novavax vaccine being given in Berlin, Germany on 28 February, 2022, People wait in separate queues to receive the Novavax and Pfizer vaccines in Berlin, Germany on 28 February 2022, Health Secretary Sajid Javid toured the Fujifilm site in Teesside in February. I am pleased to confirm today that this authorisation has been granted, providing access to a fifth vaccine that can be used to help protect us from COVID-19. [49] Novavax's work is in competition for vaccine development among dozens of other companies. Dont include personal or financial information like your National Insurance number or credit card details. Bakhmut attacks still being repelled, says Ukraine, Saving Private Ryan actor Tom Sizemore dies at 61, US lawyer jailed for murdering wife and son, The children left behind in Cuba's mass exodus, Xi Jinping is unveiling a new deputy - why it matters, Snow, Fire and Lights: Photos of the Week. [43], Novavax signed an agreement with Serum Institute of India for mass scale production for developing and low-income countries. I've been really interested in whether novavax could alleviate the incoming drops in supply for April but can't seem to find any actual info on how much production is already occuring/planning to occur in early Q2 of 2021 WHO does not recommend The most common reason for remaining unvaccinated is concern about side effects, followed by worries the jabs have not been tested sufficiently. Anyone with a body temperature over 38.5C should postpone vaccination until they no longer have a fever. government. The Joint Committee on Vaccination and Immunisation (JCVI) determines which vaccines are deployed, and which age groups are offered a vaccination. "I had to blag it a bit," she says. The approval follows a review of the safety, quality and effectiveness of the vaccine in this age group, and expert advice from the governments independent scientific advisory body, the Commission on Human Medicines. Access to a broader range of vaccines would also be helpful if regular booster shots are needed in the future. Novavax, a small American company buoyed by lavish support from the U.S. government, announced on Monday the results of a clinical trial of its Covid-19 vaccine in the United States and. Novavaxs offering is a protein-based jab similar to those used to protect against flu, and for routine childhood vaccination against pertussis (whooping cough) or meningococcal infection. The Novavax COVID vaccine also looks like it performs well. Up until now, the FDA has only given the OK to three . Last month she travelled from the UK to a vaccine clinic in France to have the Novavax jab. To help us improve GOV.UK, wed like to know more about your visit today. Jeff Clabaugh has spent 20 years covering the Washington region's economy and financial markets for WTOP as part of a partnership with the Washington Business Journal, and officially joined the WTOP newsroom staff in January 2016. Trials show the protein-based jab causes fewer side-effects and hundreds of British jobs depend on it. The Novavax vaccine can be offered to people who have had COVID-19 in the past. A first booster dose is recommended 4-6 months after the completion of the primary series. Like WTOP on Facebook and follow WTOP on Twitter and Instagram to engage in conversation about this article and others. 5425 Wisconsin Ave Achieved revenues in fourth quarter 2022 of $357 million and full year 2022 of $2.0 billion; Appointed John C. Jacobs as President and Chief Executive Officer; Updated U.S. government agreement to include up to 1.5 million additional doses of Novavax's COVID-19 vaccine for delivery in 2023; Expanded Nuvaxovid label in adult booster and adolescent primary series The FDA committee. The coronavirus (COVID-19) vaccines are safe and effective. What's the least amount of exercise we can get away with? The government has ordered 60m doses of Novavax ahead of its expected approval. Novavax shares jump ahead of expected approval from the EU's drug regulator for its Covid-19 vaccine, which uses a more conventional technology than mRNA. The Novavax vaccine is the fourth one to be authorized in the United States for the prevention of COVID-19. On Jan. 31, Novavax formally submitted its request to the Food and Drug Administration (FDA) to have its COVID-19 vaccine approved for EUA. [4], In May 2021, Serum Institute of India said that it started the production of the Novavax COVID19 vaccine candidate branded as Covovax in India after receiving permission from the Indian government. The Novavax vaccine will be manufactured in two different facilities. Very rare serious adverse events of myocarditis and pericarditis have been observed though cases typically occurred within a few days after vaccination, and were generally mild. Both have been through formal clinical trials and found to be safe and effective by medicines regulators, while real-world monitoring over the past year suggests serious side effects are extremely rare. WTOP.com | Alexa | Google Home | WTOP App | 103.5 FM, It really doesnt concern me: Arlington Co. official reacts after Amazon HQ2 construction put on hold, Franklin Square leases up despite pandemic, office downsizing, 'It really doesn't concern me': Arlington Co. official reacts after Amazon HQ2 construction put on hold, Doctor: Lesion removed from Biden's chest was cancerous, Gusty winds expected to blast the DC area this weekend. The Serum Institute of India is also manufacturing doses, 20m of which have been approved for export to Indonesia. The MHRA is an executive agency of the Department of Health and Social Care. She caught Covid last year and spent five nights in hospital on oxygen. Adjuvants. [58][59] A spokesperson for Novavax stated that the $1.6billion was coming from a "collaboration" between the Department of Health and Human Services and Department of Defense,[58][59] where General Gustave F. Perna has been selected as COO for Warp Speed. But when the vaccine was finally given medical approval in the UK in February 2022, it was on the basis that initial doses would come, not from Teesside, but from the Serum Institute in India. The fact that it uses a more established vaccine technology could also make it more appealing. The BBC is not responsible for the content of external sites. [51] Under the partnership, Emergent BioSolutions was supposed to manufacture the vaccine at large scale at their Baltimore facility. The $1.6 billion award is to fund the production of 100 million doses by early 2021. comment s Monday, June 14, 2021 U.S. clinical trial results show Novavax vaccine is safe and prevents COVID-19 Results from a Phase 3 clinical trial enrolling 29,960 adult volunteers in the United States and Mexico show that the investigational vaccine known as NVX-CoV2373 demonstrated 90.4% efficacy in preventing symptomatic COVID-19 disease. Wed like to set additional cookies to understand how you use GOV.UK, remember your settings and improve government services. The trial will assess a CIC vaccine comprised of Novavax's recombinant protein-based COVID-19 vaccine, quadrivalent influenza vaccine candidate, and patented saponin-based Matrix-M adjuvant. Final data from its phase 3 trial is expected any day now, paving the way for the companies to seek regulatory approval. Nuvaxovid was authorised for use by the MHRA for those aged 18 and over on 3 February 2022. "I think some people are reassured by the decades of safety profiles which are based on this technology.". The independent Commission on Human Medicines and its COVID-19 Expert Working Group has carefully considered the available evidence on safety, quality and effectiveness. "But the language barrier actually helped because I just looked confused.". AOC under investigation for Met Gala dress, Mother who killed her five children euthanised, Alex Murdaugh jailed for life for double murder, Zoom boss Greg Tomb fired without cause, The children left behind in Cuba's exodus, US sues Exxon over nooses found at Louisiana plant, Biden had skin cancer lesion removed - White House. Novavax and the Australian government announced an advance purchase agreement for 51 million doses of Novavax's COVID-19 vaccine in January 2021. InvestorsErika Schultz | 240-268-2022[emailprotected], MediaAli Chartan or Giovanna Chandler | 202-709-5563[emailprotected], Cision Distribution 888-776-0942 Last week's data showed that about 40 percent of people who receive Novavax report. Nuvaxovid becomes the fifth COVID-19 vaccine authorised by the UKs independent medicines regulator. The accompanying condensed consolidated financial statements have been prepared assuming Novavax will continue as a going concern. In February, Novavax secured a deal to sell the U.S. government up to an additional 1.5 million doses of its vaccine, but the federal government will stop buying vaccines from manufacturers later this year. A first booster dose is recommended 4-6 months after the completion of the primary series. Tue 11 Jan 2022 11.30 EST Last modified on Tue 11 Jan 2022 11.32 EST Australia's promised supplies of 51m doses of the Novavax vaccine, which failed to arrive in 2021 as planned, may be. [26] Efficacy is closely related to effectiveness, which is generally expected to slowly decrease over time. date: Dec 20, 2021 6:35 AM EST . Novavax is approved and available for use as a booster in people aged 18 years and over. As with all vaccines. The first part seeks to enroll a total of approximately 1,500 participants in Australia and New Zealand. People with an allergy to one of the components of the vaccine listed in the patient information leaflet should not receive the vaccine. June 14, 2021. It is also undergoing mix and match testing with the Oxford/AstraZeneca or Pfizer/BioNTech jabs and preliminary data suggest it generates a robust immune response when given as the second dose. "I am excited to be joining Novavax at this important time in the company's history," said John C. Jacobs, President and Chief Executive Officer, Novavax. This article provides a summary of those interim recommendations. Sponsor and vaccine. [61], On 24 September 2020, Novavax started for a phase III trial with 15,000 in the UK. ", "Over the past few weeks, the management team and I have identified three near-term priorities that we believe are essential to our success this year and beyond: 1) to deliver a competitive product for the upcoming 2023 fall vaccination season; 2) to reduce our rate of spend, manage our cash flow, and evolve our scale and structure; and 3) to leverage our technology platform, our capabilities and our portfolio of assets to drive additional value beyond Nuvaxovid alone. [29], The most common side effects include fever, headache, nausea, muscle and joint pain, tenderness and pain at the injection site, tiredness, and feeling unwell. Novavax estimates it has sufficient capital available to fund operations this year, but this is subject to significant uncertainty, including as it relates to 2023 revenue, funding from the U.S. government and pending arbitration. Medicine regulators also continue to collect data, so vaccine safety can be monitored and any possible adverse reactions can be investigated. Gaithersburg, Maryland-based Novavax lost as much as a quarter of its value Wednesday after the company warned of substantial doubt about its ability to stay in business. Other protein-based Covid vaccines are also in late-stage clinical trials, including one being developed by Sanofi and GSK, again with 60m orders from the UK. Novavax reported that a part II of its phase III study on the COVID-19 Omicron BA.1 vaccine candidate will evaluate the candidate vaccine compared with an Omicron BA.5 vaccine, as well as a . A replay of the webcast will be available on the Novavax website until May 28, 2023. To further reduce the risk of severe disease, deaths and disruptions of health services, WHO recommends countries should consider a second booster dose 4-6 months after the first booster dose for all older persons, all persons with moderate and severe immunocompromising conditions, regardless of age, adults with comorbidities, pregnant persons and health workers. This combination of easier transport and storage is even more important in developing countries, where low temperature-controlled supply chains are less well established. . I dont know how long the approvals process will take but hope production will get up and running soon, he said. It is impossible to compare vaccine head-to-head due to the different approaches taken in designing the respective studies, but overall, all of the vaccines that have achieved WHO Emergency Use Listing are highly effective in preventing severe disease [67][35], On 12 March 2021, Novavax announced their vaccine candidate was 96.4% effective in preventing the original strain of COVID-19 and 86% effective against the Alpha variant. About 300 people at FujiFilm are said to have been working on the vaccine, though delays had prompted concerns that jobs would be hit. Delivered over 100 million doses of Nuvaxovid, Novavax's COVID-19 vaccine, globally to date Modified agreement with the U.S. government for up to 1.5 million additional doses of Novavax's COVID-19 . You can change your cookie settings at any time. This is when the marketing authorisation application made by the company references the decision made by the EMAs Committee for Medicinal Products for Human Use (CHMP). About the COVID-19-Influenza Combination (CIC) Vaccine Candidate Phase 2 Trial. They give you the best protection against COVID-19. In Europe, the vaccine will be manufactured under the trade name Nuvaxovid and has been approved by the European Medicines Agency, and in India, the vaccine will be manufactured by Pfizer-BioNTech . To date, Novavax said it has delivered over 100 million doses of its COVID-19 vaccine globally. [54][55] The first human safety studies of the candidate, codenamed NVX-CoV2373, started in May 2020 in Australia. July 13, 2022, 1:32 PM PDT. After months of promises, and a series of delays, the Novavax jab was finally approved for use in adults by the European Medicines Agency (EMA) in late December 2021, followed by the British equivalent, the MHRA, on 3 February 2022. Britons have become so accustomed to the three Covid vaccines available in the UK that most have forgotten about two others. As there is not currently sufficient evidence to date to evaluate the impact of the vaccine on transmission, public health and social measures must continue, including use of face masks, physical distancing, handwashing, appropriate ventilation, and other measures as appropriate in particular settings, depending on the COVID-19 epidemiology and potential risks of emerging variants. WHO has identified pregnant persons as a high priority-use group for COVID-19 vaccination, given their increased risk of severe outcomes. The Beta variant was the predominant variant to occur, with post-hoc analysis indicating a cross-protective vaccine efficacy of Novavax against Beta of 51.0% for HIV-negative participants. [40], The vaccine is produced by creating an engineered baculovirus containing a gene for a modified SARS-CoV-2 spike protein. SAGE accepts two heterologous doses of WHO EUL COVID-19 vaccines as a complete primary series.