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. All four vaccines used so far in the UK have gone through safety checks as part of the clinical trial and approval process. [29] On 19 July 2022, the US Centers for Disease Control and Prevention (CDC) recommended the Novavax COVID19 vaccine as a two-dose primary series for adults age 18 and older, thus endorsing the recommendation from the Advisory Committee on Immunization Practices (ACIP) regarding this vaccine. FDA requires vaccination providers to report vaccine administration errors, serious adverse events, cases of multisystem inflammatory syndrome, and cases of COVID-19 that result in hospitalization or death after administration of COVID-19 vaccine under an EUA. If. 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. One hurdle to overcome is that the UK vaccine programme does not currently allow someone to choose which type of jab they are given. You can change your cookie settings at any time. The sample size of each survey is small, at around 70 people, as they are investigating a hard-to-reach minority, but the results are still thought to be representative. In some other European countries, individuals can call a dedicated phone line to request the Novavax product. An 8-week interval is recommended between primary series doses of NVX-CoV2373. [54][55] The first human safety studies of the candidate, codenamed NVX-CoV2373, started in May 2020 in Australia. How many people have had boosters so far? At the time, Novavax said production should be up and running by April 2021. This news service reported 3 May that using a tweaked Covid-19 vaccine would allow for broader immunogenicity profile in the vaccine receiver. So what difference would this additional weapon make to the UKs vaccination armoury? 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%. To date, Novavax said it has delivered over 100 million doses of its COVID-19 vaccine globally. [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. The Medicines and Healthcare products Regulatory Agency is responsible for regulating all medicines and medical devices in the UK. had previously been approved in Canada for another use. [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. "Protein-based vaccines like this have quite a long history - from hepatitis to meningococcal B, to HPV," says Novavax's chief medical officer Filip Dubovsky. Kenneth, from Bristol, says he has a health condition which makes him cautious about anything that interacts with his immune system; he has been waiting for an alternative to the two main mRNA vaccines. 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. 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. This extension has been. The TGA provisionally approved Novavax for use as a primary course in Australia on 20 January 2022. [75][4][76][77], As of November 2021, it has been authorized for use in Indonesia,[78] the Philippines,[79] as of December in India,[80] as of January 2022 in South Korea,[81][82] Australia,[83][84] as of February 2022 in the United Kingdom,[85] Canada,[86] Taiwan,[87] and Singapore. Initial results are expected mid-year 2023. [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. 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. Well send you a link to a feedback form. 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. This combination of easier transport and storage is even more important in developing countries, where low temperature-controlled supply chains are less well established. Post-marketing surveillance would be needed to identify any previously unknown side-effects, he said. If approved, the Novavax vaccine is expected to be available among the second wave of jabs to provide a . Given these uncertainties, substantial doubt exists regarding our ability to continue as a going concern through one year from the date of these financial statements are issued, it said in a statement accompanying its fourth quarter results. The Novavax vaccine was one of the first on the market to work in a more traditional way - the spike protein is grown outside the body in a laboratory and then injected, alongside a separate ingredient which boosts the immune response called an adjuvant. 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. 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. Novavax COVID-19 Vaccine, Adjuvanted is available under emergency use authorization (EUA) to prevent COVID-19 in individuals 12 years of age and older. Like WTOP on Facebook and follow WTOP on Twitter and Instagram to engage in conversation about this article and others. It will take only 2 minutes to fill in. 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. [32], On 27 January 2023, Australia's Therapeutic Goods Administration indicated it will add tinnitus to its label. To help us improve GOV.UK, wed like to know more about your visit today. It involved about 130 volunteers aged between 18-59. SAGE recommends the use of the Novavax (NVX-CoV2373) vaccine as 2 doses (0.5 ml) given intramuscularly. In reaching its decision, the MHRA considered the results of 2 large clinical trials involving nearly 50,000 participants. We are pleased to say that we have advised that the benefit risk balance of Nuvaxovid is positive. 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 . Our approval of Nuvaxovid today follows a rigorous review of the safety, quality and effectiveness of this vaccine, and expert advice from the governments independent scientific advisory body, the Commission on Human Medicines. 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. [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. The TGA has received applications and is assessing data for the following COVID-19 vaccines. A first booster dose is recommended 4-6 months after the completion of the primary series. [28] Overall efficacy against different SARS-CoV-2s was 90.4% and efficacy against moderate-to-severe disease was 100%. The approval authorises the use of this vaccine in people aged 18 and over for a first and second dose. Nuvaxovid was authorised for use by the MHRA for those aged 18 and over on 3 February 2022. [41][70][71], On 14 June 2021, Novavax announced overall 90.4% efficacy in the Phase III U.S. & Mexico trial that involved nearly 30,000 people aged 18 years of age and older. By accepting all cookies, you agree to our use of cookies to deliver and maintain our services and site, improve the quality of Reddit, personalize Reddit content and advertising, and measure the effectiveness of advertising. The Novavax vaccine is the fourth one to be authorized in the United States for the prevention of COVID-19. Novavax has a version of its vaccine specific for the Beta variant of concern in preclinical investigations. For real-time updates including the latest press releases and news statements, see our Twitter channel at https://www.twitter.com/mhragovuk. News centreMHRA The independent Commission on Human Medicines and its COVID-19 Expert Working Group has carefully considered the available evidence on safety, quality and effectiveness. The most common reason for remaining unvaccinated is concern about side effects, followed by worries the jabs have not been tested sufficiently. NEWS ALERT: Lesion removed from Bidens chest was cancerous; no further treatment required, Jeff Clabaugh | jclabaugh@wtop.com. You can change your cookie settings at any time. 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. Novavax Covid Vaccine: Approval, Release Date, Efficacy What to Know About Novavax, a Possible Fourth COVID Vaccine Option in the US. 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. 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. Total revenue for 2022 was $1.9 billion, 73% more than its full-year revenue in 2021. 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. 8 June 2022 by Alexis Jones. 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. 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. Novavax shares sank as much as 25% after the COVID-19 vaccine maker warned Tuesday it has "substantial doubt" about its ability to stay in business through next year and it plans cuts to its spending. 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. Last week's data showed that about 40 percent of people who receive Novavax report. [35], NVX-CoV2373 has been described as both a protein subunit vaccine[36][37] and a virus-like particle vaccine,[38][39] though the producers call it a "recombinant nanoparticle vaccine". Fujifilm Diosynth would manufacture them at its plant in Billingham, while GSK would fill and finish them package them up in vials at its operation in Barnard Castle. Even so, that was on the low end of the companys revised forecast issued last summer, and half its previous forecast for 2022 revenue. [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. Six per cent also said it was because the specific vaccine they wanted was not yet available in the UK. Nuvaxovid. [91][92] She had wanted a vaccine previously, but was unsure about the Pfizer and Moderna jabs which have been rolled out in their tens of millions across the UK. [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. 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. Its protein-based Covid-19 vaccine . and hospitalization due to COVID-19. In late September, Novavax entered the final stages of testing its coronavirus vaccine in the UK. In February, the UK medicines regulator approved the first Covid vaccine based on an older, more established technology. 2023 WTOP. 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 Under the interim order, a company could submit an application for a drug or vaccine for use in COVID-19 that: had never been approved in Canada. The formulation includes a saponin-based adjuvant[36][37][40] named Matrix-M. On 24 February 2021, Novavax partnered with Takeda to manufacture the vaccine in Japan, where its COVID19 vaccine candidate is known as TAK-019. [61], On 24 September 2020, Novavax started for a phase III trial with 15,000 in the UK. In view of these findings, WHO recommends the use of Novavax (NVX-CoV2373) vaccine according to the WHO Prioritization Roadmap, even if currently recognized Variants of Concern (VOC) are present in the country. [43], Novavax signed an agreement with Serum Institute of India for mass scale production for developing and low-income countries. The vaccine effectiveness reached 80% for this population. Pfizer-BioNTech . On 4 November, the company submitted an emergency use application to the World Health Organization. "It's been so frustrating - and it's not just me," says a woman in her 40s, who did not want to be named. Medicine regulators also continue to collect data, so vaccine safety can be monitored and any possible adverse reactions can be investigated. This website is not intended for users located within the European Economic Area. There are insufficient data still for Omicron. Date published: 2023-01-12. In accordance with the WHO Prioritization Roadmap, the highest priority-use groups (e.g. 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. [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. Log in to your WTOP account for notifications and alerts customized for you. 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. 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; unanticipated challenges or delays in conducting clinical trials; challenges meeting contractual requirements under agreements with multiple commercial, governmental, and other entities; manufacturing delays or challenges, including as a result of the timing of the anticipated regulatory requirements for the fall 2023 vaccination season; the loss of future funding from the U.S. government; the potential for an unfavorable outcome in disputes, including the pending arbitration with Gavi; 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's Annual Report on Form 10-K for the year ended December 31, 2021 and subsequent Quarterly Reports on Form 10-Q, as filed with the Securities and Exchange Commission (SEC). The national drug regulator has approved the Novavax vaccine, as well as two oral treatments for vulnerable patients with COVID-19. 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. ET. Why are 'anti-vaxxers' excited about it? [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%. To access the replay by telephone, dial (877) 344-7529 (Domestic) or (412) 317-0088 (International) and use passcode 1137418. Read about our approach to external linking. Having multiple types of vaccines offers more options and flexibility for the public, jurisdictions, and vaccine providers. News stories, speeches, letters and notices, Reports, analysis and official statistics, Data, Freedom of Information releases and corporate reports. The other is the Novavax jab; the government has ordered 60m doses and hundreds of British jobs depend on it. SAGE will update this advice as information on the impact of vaccination on virus transmission and indirect protection is assessed. [88][89] As of December 2021 it was validated by the World Health Organization. Novavax CEO: FDA filing for COVID-19 vaccine is 'probably going to be next week'. ET on March 7, 2023. [4], Additional possible side effects include anaphylaxis (severe allergic reaction), paresthesia (unusual feeling in the skin, such as tingling or a crawling sensation) and hypoesthesia (decreased feeling or sensitivity, especially in the skin), and pericarditis (inflammation of lining around the heart). 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 government has ordered 60m doses of Novavax ahead of its expected approval. We also use cookies set by other sites to help us deliver content from their services. You have accepted additional cookies. The study enrolled more than 15,000. 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). Key points: The government has ordered 51 million doses of the Novavax vaccine Around 800,000 doses of the anti-viral pills are expected to arrive in the coming weeks Novavax asked the Food and Drug Administration on Monday to authorize its protein-based Covid-19 vaccine for adults. On 23 July 2021, the TGA approved the Pfizer COVID-19 vaccine for teenagers between 12 and 15 years old. WHO does not recommend pregnancy testing prior to vaccination. 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 . Government advice on public health and social measures should continue to be followed by both vaccinated and unvaccinated individuals. The Novavax jab has already been approved for use in the Philippines and Indonesia. 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. Who can get a COVID-19 vaccine Everyone aged 5 (on or before 31 August 2022) and over can get a 1st and 2nd dose of the COVID-19 vaccine. [40], The vaccine is produced by creating an engineered baculovirus containing a gene for a modified SARS-CoV-2 spike protein. [52] However, following production issues with the Johnson & Johnson and OxfordAstraZeneca vaccines at its Baltimore plant and to decrease the burden on the plant, Novavax subsequently partnered with a different manufacturer in a new agreement overseen by the U.S. Table 2 shows the dates of provisional registrations granted to COVID-19 vaccines. Novavax's Covid-19 Vaccine Moves Closer to FDA Authorization Decision Company says it has resolved manufacturing problems that led to earlier delays; FDA is reviewing shot's authorization. "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. By Berkeley Lovelace Jr. The accompanying condensed consolidated financial statements have been prepared assuming Novavax will continue as a going concern. Novavax, Inc. (Nasdaq: NVAX) promotes improved health by discovering, developing and commercializing innovative vaccines to protect against serious infectious diseases. The fact that it uses a more established vaccine technology could also make it more appealing. . This thread is archived . Anyone with a body temperature over 38.5C should postpone vaccination until they no longer have a fever. older adults, persons with moderate to severe immunocompromising conditions, and health workers) should be offered it first. Novavax marks the fourth COVID-19 vaccine available in the U.S.. 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. Sponsor and vaccine. There is no confirmed release date for the Novavax COVID-19 vaccine. *Included in current and noncurrent liabilities as of December 31, 2022 and non-current liabilities as of, Environmental, Social and Governance (ESG), HVAC (Heating, Ventilation and Air-Conditioning), Machine Tools, Metalworking and Metallurgy, Aboriginal, First Nations & Native American, Novavax to Host Conference Call to Discuss Fourth Quarter and Full Year 2022 Financial Results and Operational Highlights on February 28, 2023, Governo dos EUA e Novavax ampliam parceria, garantindo at 1,5 milhes de doses adicionais da vacina contra a COVID-19 da Novavax, 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 vaccine for delivery in 2023, Agreement maintains the U.S. public's access to Novavax's COVID-19 vaccine and supports the development of smaller dose vials, strain selection in line with U.S. Food and Drug Administration (FDA) recommendations and a smooth transition to the commercial market, Reaffirmed intent to deliver an updated mono- or bivalent strain vaccine for the 2023 fall vaccination season, consistent with public health recommendations, Secured European Medicines Agency (EMA) and FDA approval of Nuvaxovid five-dose vial variation and EMA approval of the Company's, Presented data to the U.S. FDA Vaccine and Related Biological Products Advisory Committee demonstrating that when used as a booster, Novavax's COVID-19 vaccine induces broad functional immune responses, including for contemporary variants, Part 2 to evaluate our prototype vaccine compared to an Omicron BA.5 vaccine, as well as a bivalent containing prototype and Omicron BA.5 vaccine, Expanded Nuvaxovid label in adult booster and adolescent primary series to enable broader uptake in the long-term commercial market, Initiated Phase 2 dose-confirming trial to evaluate safety and immunogenicity of different formulations of CIC and influenza stand-alone vaccine candidates in adults aged 50 to 80 years, with topline results expected by mid-year 2023, CIC Phase 2 trial includes additional study arms exploring alternate influenza stand-alone formulations. Up until now, the FDA has only given the OK to three . 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. Dont include personal or financial information like your National Insurance number or credit card details. What's the least amount of exercise we can get away with? "Much has been achieved over the past three years, and based on the foundation that has been laid to date, I believe that Novavax has significant potential for a bright future. 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. had been approved by a trusted foreign regulatory authority. The spike proteins are harvested and assembled onto a synthetic lipid nanoparticle about 50 nanometers across, each displaying up to 14 spike proteins.[36][37][40]. [50], In March 2020, Novavax announced a collaboration with Emergent BioSolutions for preclinical and early-stage human research on the vaccine candidate. 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. News stories, speeches, letters and notices, Reports, analysis and official statistics, Data, Freedom of Information releases and corporate reports, The Medicines and Healthcare products Regulatory Agency has concluded that Nuvaxovid is safe and effective in this age group. The vaccine is already available for use in at least 170 countries, but if . A first booster dose (0.5 mL) of Novavax COVID-19 Vaccine, Adjuvanted may be administered intramuscularly at least 6 months after completion of primary vaccination with an authorized or approved COVID-19 vaccine in individuals 18 years of age and older for whom an FDA-authorized mRNA bivalent COVID-19 booster vaccine is not accessible or clinically appropriate and in individuals 18 years of . Date Covid vaccine could get approval - and how it compares to AstraZeneca . The TGA has approved Novavax for Aussies aged 18 years and older. [+] vaccine phase 3 clinical trial at the UW Virology Research Clinic on February 12, 2021, in . You have accepted additional cookies. The goal suggests the U.S. could join the U.K. on the list of countries to authorize the vaccine in the . At the moment, it is only approved as a two-dose course, which means Novavax boosters are not yet an option. "Every single one of our neighbours in the EU - Ireland, France, Belgium, the Netherlands - they all have access to Novavax. Final data from its phase 3 trial is expected any day now, paving the way for the companies to seek regulatory approval. Fujifilm last month said manufacturing was unaffected by the delay, and it planned to expand its workforce in the years to come. ", "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.". 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 . The Novavax COVID-19 Vaccine (NVX-CoV2373) is an investigational SARS-CoV-2 vaccine for the prevention of COVID-19. "But the language barrier actually helped because I just looked confused.". delaying pregnancy or terminating pregnancy because of vaccination. But the most appropriate use of Novavax over the next year or two would be to help reduce the extensive COVID vaccine inequity that exists. Get breaking news and daily headlines delivered to your email inbox by signing up here. We also carry out independent batch testing on all the approved COVID-19 vaccines to ensure that every batch meets the expected quality standards. It is great to see our world renowned medicines regulator approve another COVID-19 vaccine. [33], The vaccine requires two doses[34] and is stable at 2 to 8C (36 to 46F) refrigerated temperatures. [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.

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