One is the vaccine developed by Janssen, approved in May, with doses due to be delivered by the end of this year, but the UK government is now planning to donate all 20m of them to developing countries, via the Covax initiative. He adds he is still being as careful around other people as he was at the height of lockdown. 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. 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. Initial results are expected mid-year 2023. It traded as high as $330 a share in early 2021, and has lost more than 90% of its value in the past 12 months. Government advice on public health and social measures should continue to be followed by both vaccinated and unvaccinated individuals. The Medicines and Healthcare products Regulatory Agency is responsible for regulating all medicines and medical devices in the UK. [23] On 22 August 2022, the CDC recommended the Novavax COVID19 vaccine for adolescents aged 12-17 years. ", "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. WHO has identified pregnant persons as a high priority-use group for COVID-19 vaccination, given their increased risk of severe outcomes. There is no confirmed release date for the Novavax COVID-19 vaccine. Pfizer and BioNTech applied for U.S. EUA of their COVID-19 vaccine on Nov. 20, 2020. Nuvaxovid, the COVID-19 vaccine developed by Novavax, has today been given regulatory approval by the Medicines and Healthcare products Regulatory Agency (MHRA). ET. [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. To help us improve GOV.UK, wed like to know more about your visit today. I want the UK to be the best place in the world to conduct clinical trials. Novavax Covid Vaccine: Approval, Release Date, Efficacy What to Know About Novavax, a Possible Fourth COVID Vaccine Option in the US. Focused on the world's most urgent health challenges, Novavax is currently evaluating vaccines for COVID-19, influenza, and COVID-19 and influenza combined. [41] The spike protein was modified by incorporating two proline amino acids in order to stabilize the pre-fusion form of the protein; this same 2P modification is being used in several other COVID19 vaccines. 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. It can be stored in a standard vaccine fridge at 2C to 8C, making it easier to transport and store than mRNA-based vaccines. [94][95] On 19 August 2022, the FDA granted Emergency Use Authorization for the Novavax COVID19 vaccine in people aged 12-17 years. June 14, 2021. [40], The vaccine is produced by creating an engineered baculovirus containing a gene for a modified SARS-CoV-2 spike protein. 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 Adolescents with moderate to severe immunocompromising conditions belong to the highest priority-use group. The TGA has received applications and is assessing data for the following COVID-19 vaccines. December 23, 2021, 9:30 AM. An 8-week interval is recommended between primary series doses of NVX-CoV2373. Because of Novavaxs simpler storage requirements, it would be easier to use in GP surgeries and pharmacies, said Majeed. Another "more traditional" vaccine - produced by the French company Valneva - has just been approved by the UK medicines regulator, although the UK government currently has no doses of that jab on order. The Phase 2 dose-confirmation trial will be conducted in two parts. Novavax's COVID-19 vaccine has cleared the Food and Drug Administration's (FDA) vaccine advisory committee, but. It will take only 2 minutes to fill in. [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. However, a caveat with any new vaccine is that rarer side-effects may not become apparent until a vaccine is used widely, said Azeem Majeed, professor of primary care and public health at Imperial College London. 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). The fact that it uses a more established vaccine technology could also make it more appealing. 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. Nuvaxovid. All work is underpinned by robust and fact-based judgements to ensure that the benefits justify any risks. [53], Trials have also taken place in the United Kingdom. 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 . You have accepted additional cookies. The $1.6 billion award is to fund the production of 100 million doses by early 2021. comment s Even lifting it [vaccination rates] by a few per cent would be worth it.". We also use cookies set by other sites to help us deliver content from their services. More than 92% of over-12s in the UK have already received at least one of those Covid jabs - but that still leaves around five million people unvaccinated. The . The Matrix-M adjuvant stimulates the entry of antigen-presenting cells at the injection site and enhances antigen presentation in local lymph nodes. 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. 8 June 2022 by Alexis Jones. Britons have become so accustomed to the three Covid vaccines available in the UK that most have forgotten about two others. For the purposes of this article, the vaccine will be referred to as Novavax (NVX-CoV2373). Silvia Taylor, the senior vice-president of global corporate communications and investor relations at Novavax, said: Now that the submission [to the UK Medicine and Healthcare products Regulatory Authority] is complete, the timeline is in the hands of the regulatory agencies., Original reporting and incisive analysis, direct from the Guardian every morning. [48], In January 2020, Novavax announced development of a vaccine candidate, codenamed NVX-CoV2373, to establish immunity to SARS-CoV-2. 28 September 2020 to January 2021, United Kingdom. yorkshirepost.co.uk. [42] The baculovirus is made to infect a culture of Sf9 moth cells, which then create the spike protein and display it on their cell membranes. SAGE recommends the use of the Novavax (NVX-CoV2373) vaccine as 2 doses (0.5 ml) given intramuscularly. government. Cookie Notice is compromised, these recommendations will be updated accordingly. While our current cash flow forecast for the one-year going concern look forward period estimates that we have sufficient capital available to fund operations, this forecast is subject to significant uncertainty, including as it relates to 2023 revenue, funding from the U.S. government, and pending arbitration. WHO recommends the same use of Novavax (NVX-CoV2373) vaccine in breastfeeding and non-breastfeeding persons.Vaccine effectiveness is expected to be similar in breastfeeding persons as in other adults. The vaccine is not recommended for people younger than 12 years of age. As Novavax This webpage was updated on 28 September 2022 to reflected updated interim recommendations. This combination of easier transport and storage is even more important in developing countries, where low temperature-controlled supply chains are less well established. On 4 November, the company submitted an emergency use application to the World Health Organization. Dr. Stephaun Wallace receives his second injection from Dr. Tia Babu during the Novavax Covid-19 . It involved about 130 volunteers aged between 18-59. Novavax, Inc. (Nasdaq: NVAX) promotes improved health by discovering, developing and commercializing innovative vaccines to protect against serious infectious diseases. 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. The Novavax jab has already been approved for use in the Philippines and Indonesia. 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. In accordance with the WHO Prioritization Roadmap, the highest priority-use groups (e.g. The Food and Drug Administration on Wednesday authorized Novavax's protein-based Covid vaccine for adults, providing Americans with an . [32], On 27 January 2023, Australia's Therapeutic Goods Administration indicated it will add tinnitus to its label. 26 August 2022 Nuvaxovid, the COVID-19 vaccine developed by Novavax, has today been granted an extension to its existing UK approval, for 12- to 17-year-olds. 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 [4], A vaccine is generally considered effective if the estimate is 50% with a >30% lower limit of the 95% confidence interval. 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. One hurdle to overcome is that the UK vaccine programme does not currently allow someone to choose which type of jab they are given. This extension has been authorised by the Medicines and Healthcare products Regulatory Agency (MHRA). Even so, that was on the low end of the companys revised forecast issued last summer, and half its previous forecast for 2022 revenue. A webcast of the conference call can also be accessed on the Novavax website at novavax.com/events. . They give you the best protection against COVID-19. Updated: Oct. 20, 2022.] Check benefits and financial support you can get, Find out about the Energy Bills Support Scheme, Medicines and Healthcare products Regulatory Agency, The Conditional Marketing Authorisation (CMA) granted by the MHRA, 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). In some other European countries, individuals can call a dedicated phone line to request the Novavax product. Please visit novavax.com and LinkedIn for more information. The goal suggests the U.S. could join the U.K. on the list of countries to authorize the vaccine in the . In 2023, Novavax intends to focus the organization to align our investments and activities with our top priority of delivering an updated Covid-19 vaccine consistent with public health recommendations for strain composition for the 2023 fall vaccination season. Pfizer, AstraZeneca, Moderna. The efficacy of Novavax(NVX-CoV2373) in adolescents 12 to 17 years of age was evaluated in an interim analysis of the paediatric expansion portion of the ongoing phase 3 study in United States. As of 26 August 2022, Nuvaxovid has not been deployed in the UKs COVID-19 vaccination programme. We use some essential cookies to make this website work. How many people have had boosters so far? We are pleased to say that we have advised that the benefit risk balance of Nuvaxovid is positive. To access the replay by telephone, dial (877) 344-7529 (Domestic) or (412) 317-0088 (International) and use passcode 1137418. [72] From the total 77 COVID-19 cases found in the trial participants, 14 occurred in the vaccine group, while 63 occurred in the placebo group. [96], "Covovax" redirects here. News centreMHRA Novavax is targeting a second-quarter FDA filing for emergency use of its COVID-19 vaccine. Former vaccines chief sounds warning about UK pandemic readiness, Updated Moderna Covid booster gives even better protection than earlier jab, From nasal vaccines to pills: the next defences against Covid, Covid vaccines cut global death toll by 20m in first year, study finds, UKhas missed chances to prepare for future pandemics, says ex-vaccines tsar, Moderna to build UKs first mRNA vaccine research and manufacturing centre, Trials of new Covid vaccine raise hopes of once-a-year booster, Atleast 25m people in UK to be offered Covid booster this autumn, Fourth Covid jab can give higher immunity than initial booster, study finds. Anyone with a body temperature over 38.5C should postpone vaccination until they no longer have a fever. Both the Pfizer and Moderna jabs have been tested on a cross-section of the population, including people with a variety of health conditions. Total revenue for 2022 was $1.9 billion, 73% more than its full-year revenue in 2021. [56][57], In July 2020, the company announced it might receive US$1.6 billion from Operation Warp Speed to expedite development of its coronavirus vaccine candidate by 2021 if clinical trials show the vaccine to be effective. A first booster dose is recommended 4-6 months after the completion of the primary series. The TGA has approved Novavax for Aussies aged 18 years and older. The Novavax COVID-19 Vaccine, Adjuvanted is administered as a two-dose primary series, three weeks apart. . 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. [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. The Serum Institute of India is also manufacturing doses, 20m of which have been approved for export to Indonesia. WHO lists 10th COVID-19 vaccine for emergency use : Nuvaxovid, The Janssen Ad26.COV2.S COVID-19 vaccine: What you need to know, The Moderna COVID-19 (mRNA-1273) vaccine: what you need to know, The Pfizer BioNTech (BNT162b2) COVID-19 vaccine: What you need to know, The Sinovac-CoronaVac COVID-19 vaccine: What you need to know, The Sinopharm COVID-19 vaccine: What you need to know, The Oxford/AstraZeneca (ChAdOx1-S [recombinant] vaccine) COVID-19 vaccine: what you need to know, Independent Oversight and Advisory Committee, Strategic Advisory Group of Experts on Immunization, Interim recommendations for use of the Novavax NVX-CoV2373 vaccine against COVID-19, The Novavax vaccine against COVID-19: What you need to know. Novavax asked the Food and Drug Administration on Monday to authorize its protein-based Covid-19 vaccine for adults. 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. date: Dec 20, 2021 6:35 AM EST . 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 Novavax jab has already been approved for use in the Philippines and Indonesia. The Technical Advisory Group for Emergency Use Listing listed Nuvaxovid (NVX-CoV2373) vaccine against COVID-19 and Covovax (NVX-CoV2373) vaccine against COVID-19 for emergency use on 20 December 2021 and 17 December 2021 respectively. Six per cent also said it was because the specific vaccine they wanted was not yet available in the UK. Most side effects - like a sore arm or headache - are mild, with the risk of a severe reaction extremely low. We believe that if we succeed in executing against these priorities, we will position the company well for long-term success. The first part seeks to enroll a total of approximately 1,500 participants in Australia and New Zealand. TGA Provisional Approval of Moderna COVID-19 vaccine to include 12-17 years age group A first booster dose is recommended 4-6 months after the completion of the primary series. Novavax told the Guardian that it was now routinely producing high-quality product at commercial scale at multiple sites across the world. [61], On 24 September 2020, Novavax started for a phase III trial with 15,000 in the UK. 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. In late January, Novavax announced its protein-based vaccine showed a 89.3% efficacy against coronavirus in a U.K.-based trial, which it noted was during a peak period of transmission and. But while it is now available in much of Europe, Novavax is still not cleared for use in the UK. 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 . 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 will host its quarterly conference call today at 4:30 p.m. 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. The Joint Committee on Vaccination and Immunisation (JCVI) determines which vaccines are deployed, and which age groups are offered a vaccination. Reddit and its partners use cookies and similar technologies to provide you with a better experience. Novavax said today it will file for FDA approvals in the third quarter for its COVID-19 vaccine NVX-CoV2373, after it showed 90.4% overall efficacy, and 93% efficacy against the . The TGA provisionally approved Novavax for use as a primary course in Australia on 20 January 2022. Well send you a link to a feedback form. 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. The JCVI's chair of Covid-19, Professor Wei Shen Lim, says only that the vaccine's potential use remains "under consideration" and full advice will be published in "due course". Last week's data showed that about 40 percent of people who receive Novavax report. [30][68], On 28 January 2021, Novavax reported that interim results from a trial in South Africa showed a lower effectiveness rate against the Beta variant (lineage B.1.351), at around 5060%. Dr. Nita Patel, Director of Antibody discovery and Vaccine development, lifts a vial with a potential coronavirus, COVID-19, vaccine at Novavax labs in Gaithersburg, Maryland on March 20, 2020 . [51] Under the partnership, Emergent BioSolutions was supposed to manufacture the vaccine at large scale at their Baltimore facility. 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. The coronavirus (COVID-19) vaccines are safe and effective. On 13 July 2022, the FDA authorized NVX-CoV2373 for emergency use as a primary immunization (not booster) in adults. Novavax has a version of its vaccine specific for the Beta variant of concern in preclinical investigations. 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. Novavax COVID-19 Vaccine, Adjuvanted indicated for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The vaccine is stored at 2- 8 Celsius, enabling the use of existing vaccine supply and . 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. Approval for use in Australia. "But the language barrier actually helped because I just looked confused.". The first shipment to Australia of the Novavax vaccine is expected in the coming month. Privacy Policy. 10 South ColonnadeLondonE14 4PU, During office hours: 020 3080 7651 (08:30 - 17:00), Out of office hours: 07770 446 189 (17:00 - 08:30), Office hours are Monday to Friday, 8:30am to 5pm. The local Labour MP, Alex Cunningham, who represents Stockton North, met with a representative of Novavax and said he felt reassured. In line with the WHO Prioritization Roadmap and the WHO Values Framework, older adults, health workers and immunocompromised persons should be prioritised. We also use cookies set by other sites to help us deliver content from their services. So what difference would this additional weapon make to the UKs vaccination armoury? It is great to see our world renowned medicines regulator approve another COVID-19 vaccine. 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. . It is expected that should Novavax be provisionally approved for use, it will require two doses. [citation needed], On 30 June 2021, a primary Novavax-funded study published in The New England Journal of Medicine, showed that the vaccine has an overall efficacy of 83.4% two weeks after the first dose and 89.7% one week after the second dose. I dont know how long the approvals process will take but hope production will get up and running soon, he said. [5] In November 2021, the EMA received application for conditional marketing authorization. Novavax stock had dropped more than 23% in mid-morning Wednesday trading, to $7.09 per share. "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. Persons with acute PCR-confirmed COVID-19 should not be vaccinated until after they have recovered from acute illness and the criteria for ending isolation have been met. [50], In March 2020, Novavax announced a collaboration with Emergent BioSolutions for preclinical and early-stage human research on the vaccine candidate. Age modifications . Can Nigeria's election result be overturned? 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. "I think [the Novavax vaccine] could make a difference," says Dr Peter English, a retired consultant in communicable disease control and former editor of the journal Vaccines in Practice. 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. Novavax marks the fourth COVID-19 vaccine available in the U.S.. This news service reported 3 May that using a tweaked Covid-19 vaccine would allow for broader immunogenicity profile in the vaccine receiver. The approval authorises the use of this vaccine in people aged 18 and over for a first and second dose. This website is not intended for users located within the European Economic Area. Dont worry we wont send you spam or share your email address with anyone. The vaccine effectiveness reached 80% for this population. In a Phase 3 study conducted in the USA and Mexico during a period in which multiple variants (Alpha, Beta and Delta) were in circulation, vaccine efficacy against mild, moderate, or severe COVID-19 was 90%. He stresses that he is not anti-vaccination. [+] vaccine phase 3 clinical trial at the UW Virology Research Clinic on February 12, 2021, in . ", "By now, someone in Germany who got their first Novavax vaccine at the end of February could have had their full primary series and be getting on with their life - whereas I'm still waiting around in a sort-of personal lockdown, so that is really frustrating.". Covid vaccines: How fast is worldwide progress? 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 *Included in current and noncurrent liabilities as of December 31, 2022 and non-current liabilities as of December 31, 2021. 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. The Interim order expired September 16, 2021 so all new . The FDA authorized the vaccine on Dec. 11 -- barely over three weeks later. Having multiple types of vaccines offers more options and flexibility for the public, jurisdictions, and vaccine providers. 2023 BBC. The COVID-19-Influenza Combination (CIC) Vaccine Candidate Phase 2 Trial is a dose-confirming, randomized, observer-blinded trial evaluating the safety and effectiveness (immunogenicity) of different formulations of the CIC and influenza vaccine candidates in adults aged 50 through 80. We also carry out independent batch testing on all the approved COVID-19 vaccines to ensure that every batch meets the expected quality standards. 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. Nuvaxovid (Novavax) is approved and available for use as a primary course in people aged 12 years and over. Medicine regulators also continue to collect data, so vaccine safety can be monitored and any possible adverse reactions can be investigated. When added to vaccines, Novavax's patented saponin-based Matrix-M adjuvant enhances the immune system response, making it broader, and more durable. Table 2 shows the dates of provisional registrations granted to COVID-19 vaccines. Nuvaxovid, the COVID-19 vaccine developed by Novavax, has today been granted an extension to its existing UK approval, for 12- to 17-year-olds. At the time, Novavax said production should be up and running by April 2021. 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. and our [30] A post hoc analysis showed an efficacy of 86.3% against the B.1.1.7 (Alpha) variant and 96.4% against "non-B.1.1.7 strains", the majority of which were the "prototype strains" (original strain). Wed like to set additional cookies to understand how you use GOV.UK, remember your settings and improve government services. [74] On 20 December 2021, the European Commission granted a conditional marketing authorization across the EU, following a recommendation from the European Medicines Agency (EMA), for it to be sold under the brand name Nuvaxovid. A replay of the webcast will be available on the Novavax website until May 28, 2023. 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.
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