Telecom Review finds that 700 MHz 5G network construction drives investment and brings benefits to telecom vendors in China

DUBAI, UAE, Aug. 11, 2021 /PRNewswire/ — Telecom Review finds that Chinese telecom carriers are making significant progress in constructing low-band 5G networks, and much of the attention is drawn to the 700MHz frequency which is part of the wider ultra-high frequency (UHF) band.

At the beginning of 2021, China Mobile and China Broadcasting Network (CBN) had announced a 5G strategic cooperation agreement to construct and share a 700 MHz 5G network. As a combined effort, they have purchased 480,400 700 MHz 5G base stations this year. According to Guang Yang at Strategy Analytics, this increase of base stations in 700 MHz will be a significant boost to the 5G infrastructure market and also a catalyst for the 5G development in China, since most of the 5G base stations in China so far are deployed in the 2.6 GHz or 3.5 GHz band.

China Telecom and China Unicom have also jointly launched the centralized procurement of 242,000 5G base stations and have recently released the announcement on public bidding involving the 2.1 GHz wireless primary device needed in the 5G SA construction project in 2021.

Telecom Review reports the increased 5G activities in 700 MHz band will drive 5G investment in China and benefit domestic equipment vendors like Huawei. In China Mobile and CBN bidding, Huawei, as the major infrastructure vendor in China’s 5G market, has won around 60% of the total share. It is expected that Huawei will continue to be the biggest winner in the Chinese market in 2021 and the main vendor beneficiary of 5G CAPEX spending in China.

With the strength of wider coverage and low propagation loss, Telecom Review expects the low band 5G frequencies will enable a better 5G network experience and help companies like Huawei to demonstrate the true value of 5G, which will keep boosting the confidence of clients in its business continuity under the current circumstances.

About Telecom Review

Telecom Review was founded in 2005 and is today the leading global ICT media platform. With its different editions that cover all the industry’s updates in the Middle East, Asia Pacific, Africa and North America, Telecom Review has gained a stellar reputation for guaranteeing quality content, offering reliable information and addressing the most trending topics. Telecom Review has always been a pioneer in the ICT media industry by launching e-newsletters, digital flipping magazines and most recently, organizing virtual panels and webinars.

Lantronix achève l’acquisition du segment d’activité isolable d’électronique et logiciels de Communications Systems, Inc.

IRVINE, Californie, 11 août 2021 (GLOBE NEWSWIRE) — Lantronix, Inc. (« Lantronix ») (NASDAQ : LTRX), fournisseur mondial de logiciels en tant que service (Saas), services de connectivité et d’ingénierie, et solutions matérielles intelligentes et clés en main pour l’Internet des objets (IdO) et la gestion des environnements distants (REM), a annoncé aujourd’hui avoir finalisé son acquisition précédemment annoncée de Transition Networks et Net2Edge, comprenant la majorité du segment d’activité isolable d’électronique et logiciels de Communications Systems, Inc. (NASDAQ : JCS) (« CSI »).La transaction apportera une échelle immédiate à Lantronix, avec des revenus de la société combinée qui devraient totaliser plus de 100 millions de dollars par an. L’acquisition apportera des produits et des capacités de connectivité IdO complémentaires, y compris des produits de commutation, d’alimentation par Ethernet (PoE), des produits de conversion média et des adaptateurs.

Lantronix voit d’importantes synergies d’exploitation et de développement de produits au sein de la société combinée et s’attend à ce que d’importantes synergies au premier jour génèrent une désactualisation immédiate des revenus non conformes aux PCGR à la clôture, et la société prévoit en outre de réaliser 7 millions de dollars de synergies annuelles de taux d’exploitation au cours des 24 premiers mois. Lantronix publiera des directives pour son exercice 2022 lors de sa conférence téléphonique sur les résultats du quatrième trimestre 2021, dont la date sera bientôt fixée.

La Silicon Valley Bank, la banque des sociétés les plus innovantes au monde et leurs investisseurs, ainsi que SVB Capital, ont fourni un financement d’acquisition.

O’Melveny & Myers LLP a occupé le poste de conseiller juridique chez Lantronix.

À propos de Lantronix
Lantronix Inc. est un fournisseur mondial de solutions clés en main sécurisées pour l’Internet des Objets (IdO) et la gestion des environnements distants (REM), proposant des logiciels en tant que services (SaaS), des services de connectivité, des services d’ingénierie et des solutions d’ingénierie et des solutions matérielles intelligentes. Lantronix permet à ses clients de fournir des solutions d’informatique en périphérie pour l’IdO et d’OOBM (gestion hors bande) fiables et sécurisées, tout en raccourcissant les délais de mise sur le marché. Les produits et services de Lantronix simplifient considérablement la création, la mise au point, le déploiement et la gestion de projets IdO, tout en garantissant la qualité, la fiabilité et la sécurité des matériels, logiciels et solutions.

Fort de trois décennies d’expérience éprouvée dans la création de solutions robustes pour les technologies IdO et l’OOBM, Lantronix est un innovateur qui permet à ses clients de construire de nouveaux modèles commerciaux, de tirer parti d’une plus grande efficacité et de réaliser les possibilités offertes par l’Internet des Objets. Les solutions de Lantronix sont déployées à l’intérieur de millions de machines équipant des datacenters, bureaux et sites distants pour le compte d’une large gamme de secteurs, parmi lesquels l’énergie, l’agriculture, la médecine, la sécurité, la fabrication, la distribution, le transport, le commerce de détail, la finance, l’environnement et les services publics.

Lantronix a son siège à Irvine, en Californie. Pour tout complément d’information, veuillez consulter le site www.lantronix.com.

Vous en apprendrez davantage sur le blog de Lantronix, www.lantronix.com/blog, où vous trouverez les discussions et les actualités du secteur. Pour suivre Lantronix sur Twitter, veuillez vous rendre sur le site www.twitter.com/Lantronix. Visionnez notre vidéothèque sur YouTube à l’adresse www.youtube.com/user/LantronixInc ou connectez-vous avec nous sur LinkedIn à l’adresse www.linkedin.com/company/lantronix.

Discussion sur les mesures financières non conformes aux PCGR

Lantronix estime que la présentation d’informations financières non conformes aux PCGR, en conjonction avec les mesures conformes aux PCGR correspondantes, fournit des informations supplémentaires importantes à la direction et aux investisseurs concernant les tendances financières et commerciales liées à la situation financière et aux résultats d’exploitation de la société. La direction utilise les mesures non conformes aux PCGR susmentionnées pour surveiller et évaluer les résultats d’exploitation et les tendances en cours afin de mieux comprendre nos performances d’exploitation comparatives. Les mesures financières non conformes aux PCGR divulguées par la société ne doivent pas être considérées comme un substitut ou comme étant supérieures aux mesures financières calculées conformément aux PCGR, et les résultats financiers calculés conformément aux PCGR et les rapprochements des mesures financières non conformes aux PCGR avec les mesures financières calculées conformément aux PCGR doivent être soigneusement évalués. Il se peut que les mesures non conformes aux PCGR utilisées par la Société soient calculées différemment et qu’elles ne soient par conséquent pas comparables à des mesures similaires utilisées par d’autres sociétés.

Les indications sur la croissance des bénéfices par action sont fournies uniquement sur une base non conforme aux PCGR en raison de la difficulté inhérente à prévoir le calendrier ou le montant de certains éléments qui ont été exclus des mesures prospectives non conformes aux PCGR, et un rapprochement avec les directives conformes aux PCGR comparables n’a pas été fourni parce que certains facteurs qui sont importants pour la capacité de Lantronix à estimer les éléments exclus ne sont ni accessibles ni évaluables sur une base prospective sans effort déraisonnable.

Énoncés prospectifs

Le présent communiqué de presse contient des énoncés prospectifs tels que définis par la Section 27A du Securities Act de 1933, tel que modifié, et par la Section 21E du Securities Exchange Act de 1934, tel que modifié. Les déclarations qui ne sont pas strictement historiques constituent des énoncés prospectifs qui peuvent souvent, mais pas toujours, être identifiés à l’aide de termes comme « s’attend à », « croit » ou « a l’intention de », « anticipe », « prévoit », « estime », « potentiel », « possible », ou « probable », ou encore des variantes de ces mots et expressions, ou des indications que certaines actions, certains événements ou certains résultats « peuvent », « pourront », « devraient », ou « pourraient » se réaliser. Les énoncés prospectifs contenus dans le présent communiqué de presse comprennent, entre autres, des déclarations concernant les avantages attendus de l’acquisition de réseaux de Transition et de Net2Edge (la « Transaction »), y compris les synergies attendues dans la société combinée, pour Lantronix et ses actionnaires, le caractère croissant de la Transaction proposée et les résultats d’exploitation futurs prévus de la société fusionnée. Les énoncés prospectifs sont fondés sur les prévisions, hypothèses et analyses actuelles de Lantronix et sa direction à la lumière de notre expérience et de notre perception des tendances historiques, des conditions actuelles et des développements futurs prévus, ainsi que d’autres facteurs qui, selon nous, sont appropriés aux circonstances. Cependant, la question de savoir si les résultats et développements réels seront conformes aux attentes est soumise à un certain nombre de risques et d’incertitudes importants, y compris, mais sans s’y limiter : la capacité de Lantronix à intégrer avec succès les activités acquises après la transaction et à en tirer des avantages anticipés ; les risques liés à tout passif imprévu des entreprises acquises ; l’inexactitude des estimations de réserve ou des hypothèses qui les sous-tendent ; la révision des estimations des réserves en raison de l’évolution des prix des produits de base ; toute perte de direction ou de personnel clé ; l’impact de la pandémie de COVID-19, y compris l’émergence de nouvelles souches plus contagieuses et/ou résistantes aux vaccins du virus et l’impact des efforts de vaccination, y compris l’efficacité et l’acceptation par le public des vaccins, sur les activités des entreprises combinées, les employés, les chaînes d’approvisionnement et de distribution et l’économie mondiale ; et tous les autres facteurs compris dans le rapport de Lantronix sur formulaire 10-K pour l’exercice clos au 30 juin 2020, déposé auprès de la Securities and Exchange Commission (la « SEC ») le 11 septembre 2020, y compris dans la section intitulée « Risk Factors » (Facteurs de risque) du point 1A de la première partie de ce rapport ; son rapport trimestriel sur formulaire 10-Q pour le trimestre clos au 31 mars 2021, déposé auprès de la SEC le 30 avril 2021, y compris dans la section intitulée « Risk Factors » (Facteurs de risque) du point 1A de la deuxième partie de ce rapport ; et dans les autres documents publics déposés par la société auprès de la SEC. En outre, les résultats réels peuvent différer en raison d’autres risques et incertitudes que la direction de Lantronix ignore ou ne considère pas actuellement comme importants pour les activités de la société. Pour ces raisons, les investisseurs sont invités à ne pas se fier indûment aux déclarations de nature prospective. Les énoncés prospectifs de Lantronix ne sont valables qu’à la date à laquelle ils sont formulés. Lantronix décline toute obligation de révision ou de mise à jour de tout énoncé prospectif public, sauf selon la loi ou les règles du marché boursier du Nasdaq Stock Market, LLC.

Contact médias Lantronix :
Gail Kathryn Miller
Responsable du marketing et
des communications d’entreprise
media@lantronix.com
949-453-7158

Contact investisseurs et analystes Lantronix :
Jeremy Whitaker
Directeur financier
investors@lantronix.com
949-450-7241

Ventes Lantronix :
sales@lantronix.com
Amériques  +1 (800) 422-7055 (États-Unis et Canada) ou +1 949-453-3990
Europe, Moyen-Orient et Afrique  +31 (0)76 52 36 744
Asie/Pacifique  + 852 3428-2338
Chine + 86 21-6237-8868
Japon +81 (0) 50-1354-6201
Inde +91 994-551-2488

© 2021 Lantronix, Inc. Tous droits réservés.

Lantronix Conclui a Aquisição do Segmento da Unidade de Eletrônicos e Softwares Reportáveis da Communications Systems, Inc.

IRVINE, Calif., Aug. 11, 2021 (GLOBE NEWSWIRE) — A Lantronix , Inc. (Lantronix) (NASDAQ: LTRX), provedora global de Software as a Service (Saas), serviços de conectividade, serviços de engenharia, hardware inteligente e soluções turnkey para Internet of Things (Internet das Coisas – IoT) e Remote Environment Management (Gerenciamento de Ambiente Remoto – REM), anunciou hoje que concluiu a aquisição anunciada da Transition Networks e Net2Edge, que abrange a maior parte da unidade de Eletrônicos e Software reportáveis da Communications Systems, Inc. (NASDAQ: JCS) (“CSI”).

A transação irá ampliar a Lantronix imediatamente, com o aumento da receita combinada da empresa prevista para alcançar mais de US$100 milhões ao ano. A aquisição irá adicionar produtos e recursos complementares de conectividade de IoT, incluindo comutação, Power over Ethernet (PoE) e produtos de conversão de mídia e adaptador.

A Lantronix espera alcançar sinergias significativas de operação e desenvolvimento de produtos na empresa conjunta e que as sinergias significativas já a partir do primeiro dia venham impulsionar a adição de lucros não GAAP no fechamento, e espera ainda alcançar US$7 milhões em sinergias anuais de taxa de execução ao longo dos primeiros 24 meses. A Lantronix divulgará a orientação para o exercício fiscal de 2022 em sua teleconferência de ganhos do quarto trimestre do exercício fiscal de 2021, em data a ser notificada.

O Silicon Valley Bank, o banco das empresas mais inovadoras do mundo, e seus investidores, juntamente com a SVB Capital, forneceram financiamento de aquisição.

O’Melveny & Myers LLP atuou como consultor jurídico da Lantronix.

Sobre a Lantronix
A Lantronix Inc. é provedora global de soluções turnkey seguras para Internet of Things (Internet das Coisas – IoT) e Remote Environment Management (Gerenciamento de Ambiente Remoto – REM), oferecendo Software as a Service (SaaS), serviços de conectividade, serviços de engenharia e hardware inteligente. A Lantronix viabiliza que seus clientes forneçam soluções IoT Intelligent Edge e OOBM confiáveis e seguras, acelerando o tempo de colocação do produto no mercado. Os produtos e serviços da Lantronix simplificam drasticamente a criação, desenvolvimento, implantação e gerenciamento de projetos de IoT, proporcionando qualidade, confiabilidade e segurança em hardware, software e soluções.

Com três décadas de experiência comprovada na criação de tecnologias IoT e soluções OOBM robustas, a Lantronix é uma inovadora ao capacitar seus clientes a construir novos modelos de negócios, utilizar maiores eficiências e entender as possibilidades da Internet das Coisas. As soluções da Lantronix são implantadas dentro de milhões de máquinas em data centers, escritórios e locais remotos que atendem a uma ampla gama de indústrias, incluindo energia, agricultura, medicina, segurança, fabricação, distribuição, transporte, varejo, financeiro, ambiental e governamental.

A sede da Lantronix está localizada em Irvine, Califórnia. Para mais informação, visite www.lantronix.com.

Obtenha mais informações no blog da Lantronix, www.lantronix.com/blog, com discussões e atualizações da indústria. Para seguir a Lantronix no Twitter, visite www.twitter.com/Lantronix. Consulte a nossa biblioteca de vídeos no YouTube em www.youtube.com/user/LantronixInc ou conecte-se conosco no LinkedIn em www.linkedin.com/company/lantronix.

Discussão das Medidas Financeiras Não GAAP

A Lantronix acredita que a divulgação de informações financeiras não GAAP, quando divulgadas em conjunto com as medidas GAAP correspondentes, fornece informações suplementares importantes à administração e aos investidores sobre as tendências financeiras e dos negócios relacionadas à condição financeira e aos resultados das operações da empresa. A Administração usa as medidas não GAAP acima mencionadas para monitorar e avaliar os resultados e tendências operacionais em andamento para obter uma compreensão do nosso desempenho operacional comparativo. As medidas financeiras não GAAP divulgadas pela empresa não têm por objetivo substituir ou serem superiores às medidas financeiras calculadas de acordo com o GAAP, e os resultados financeiros calculados de acordo com o GAAP e as reconciliações das medidas financeiras não GAAP com as medidas financeiras calculadas de acordo com o GAAP devem ser cuidadosamente avaliados. As medidas financeiras não GAAP utilizadas pela empresa podem ser calculadas de forma diferente e, portanto, podem não ser comparáveis às medidas de títulos semelhantes utilizadas por outras empresas.

A orientação quanto ao crescimento do lucro por ação é fornecida apenas em uma base não-GAAP devido à dificuldade inerente da previsão da ocasião ou do valor de certos itens que foram excluídos das medidas não-GAAP prospectivas, e uma reconciliação com as orientações GAAP comparáveis não foi fornecida porque certos fatores que são materialmente significativos para a capacidade da Lantronix de estimar os itens excluídos não estão acessíveis ou não podem ser previstos em uma base prospectiva sem esforço não razoável.

Declarações de Previsão

Este comunicado contém “declarações de previsão” de acordo com a definição do termo estabelecido na Seção 27A da Lei de Valores Mobiliários (Securities Act) de 1933 e suas alterações, e na Seção 21E da Lei de Mercados Mobiliários (Securities Exchange Act) de 1934, e suas emendas. As declarações que não são declarações estritamente históricas constituem declarações prospectivas e muitas vezes, mas nem sempre, podem ser identificadas pelo uso de palavras como “espera”, “acredita”, “pretende”, “antecipa”, “planeja”, “estima”, “potencial”, “possível” ou “provável” ou declarações de que certas ações, eventos ou resultados “possam”, “venham a ser”, “devem” ou “poderiam” ser tomados, ocorrer ou serem alcançados. As declarações prospectivas neste comunicado de imprensa incluem, entre outras coisas, declarações sobre os benefícios esperados da aquisição da Transition Networks e da Net2Edge (a “Transação”), incluindo sinergias esperadas na empresa conjunta, para a Lantronix e seus acionistas, a natureza cumulativa da Transação proposta e os resultados operacionais futuros esperados da empresa combinada. As declarações prospectivas são baseadas em expectativas e suposições atuais e análises feitas pela Lantronix e sua administração em virtude da experiência e percepção das tendências históricas, condições atuais e desenvolvimentos futuros esperados, bem como outros fatores apropriados de acordo com as circunstâncias. No entanto, a ocorrência da conformidade dos resultados e desenvolvimentos reais com as expectativas está sujeita a uma série de riscos e incertezas materiais, incluindo, mas não se limitando a: A capacidade da Lantronix de integrar as empresas adquiridas com sucesso após a Transação e obter benefícios antecipados; riscos relacionados a quaisquer passivos imprevistos das empresas adquiridas; imprecisões das estimativas ou premissas de reserva subjacentes; revisões das estimativas de reserva como resultado das mudanças nos preços das commodities; qualquer perda de gestão ou pessoal-chave; o impacto da pandemia da COVID-19, incluindo o surgimento de novas cepas mais contagiosas e/ou resistentes à vacina do vírus e o impacto dos esforços de vacinação, incluindo a eficácia e aceitação pública das vacinas, pelas empresas, funcionários, cadeias de fornecimento e distribuição das empresas conjuntas, e na economia global; e quaisquer fatores adicionais incluídos no Relatório da Lantronix no Formulário 10-K para o exercício fiscal encerrado em 30 de junho de 2020, arquivado na Comissão de Valores Mobiliários (o “SEC”) em 11 de setembro de 2020, incluindo na seção intitulada “Fatores de Risco” no Item 1A da Parte I de tal relatório; seu Relatório Trimestral no Formulário 10-Q para o trimestre fiscal encerrado em 31 de março de 2021, arquivado no SEC em 30 de abril de 2021, incluindo na seção intitulada “Fatores de Risco” no Item 1A da Parte II de tal relatório; e nos outros registros públicos da Empresa arquivados no SEC. Além disso, os resultados reais podem ser diferentes devido aos riscos e incertezas adicionais dos quais a administração da Lantronix atualmente não tem conhecimento ou não vê como relevantes para os negócios da Empresa. Devido a tudo isso, os investidores não devem depositar confiança indevida em qualquer declaração voltada para o futuro. As declarações prospectivas que a Lantronix faz somente tem validade a partir da data em que são feitas. A Lantronix não se compromete a revisar ou atualizar publicamente quaisquer declarações prospectivas, exceto conforme exigido por lei ou pelas regras da Nasdaq Stock Market, LLC.

Contato de Mídia da Lantronix:
Gail Kathryn Miller
Gerente de Marketing e
Comunicações Corporativas
media@lantronix.com
949-453-7158

Contato para Analista e Investidor da Lantronix:
Jeremy Whitaker
Diretor Financeiro
investors@lantronix.com
949-450-7241

Lantronix Sales:
sales@lantronix.com
Américas +1 (800) 422-7055 (EUA e Canadá) ou +1 949-453-3990
Europa, Oriente Médio e África +31 (0)76 52 36 744
Ásia-Pacífico + 852 3428-2338
China + 86 21-6237-8868
Japão +81 (0) 50-1354-6201
Índia +91 994-551-2488

© 2021 Lantronix, Inc. Todos os direitos reservados.

California to Require COVID Vaccinations for Teachers, School Staff

California will require that all teachers and school staff be vaccinated or undergo weekly COVID-19 testing, Governor Gavin Newsom announced Wednesday. No other state has enacted such a requirement.

“We think this is the right thing to do, and we think this is a sustainable way to keeping our schools open and to address the number one anxiety that parents like myself have for young children,” said Newsom, who is facing a recall election.

Newsom’s mandate comes as some large school districts in California have already enacted similar rules as the delta variant spreads in the nation’s most populous state.

Health care, state workers

Recently, Newsom also mandated that health care workers get vaccinated. They don’t have the option of being tested instead. State employees are also required to be vaccinated or face weekly testing.

Meanwhile, two separate court decisions in Texas have granted local officials the authority to implement face mask mandates in defiance of Governor Greg Abbott’s order prohibiting local governments from issuing such initiatives.

A district judge in Dallas County on Tuesday issued a temporary restraining order against the governor’s order, saying Texans “have and will continue to be damaged and injured by Governor Abbott’s conduct.”

Clay Jenkins, the top Dallas County executive, had filed a lawsuit against Abbott’s executive order. Jenkins said Tuesday on Twitter that he would meet with county emergency officials in anticipation of issuing an order mandating mask wearing on Wednesday.

Another decision was handed down Tuesday in Bexar County, where a judge ruled that the county and San Antonio, its county seat, could mandate face coverings in public schools and other public buildings. County and city officials immediately issued mask mandates after the court’s ruling.

The superintendents of public schools in Dallas and Austin, the state capital, each imposed mandatory face mask orders for their districts earlier this week.

Abbott’s office has issued a statement defending his order, saying it is time for Texans to take “personal responsibility” when it comes to choosing to wear a mask.

In Florida, the Broward County school board voted Tuesday to maintain its face mask mandate in defiance of Governor Ron DeSantis, who has threatened to withhold funding from school districts and withhold the salaries of local superintendents and school board members who go against his order banning such mandates.

Different approaches

The governors of Oregon and Hawaii are taking different approaches and reimposing restrictions.

Oregon Governor Kate Brown issued an executive order Wednesday mandating that everyone return to wearing face masks indoors, regardless of their vaccination status. And Governor David Ige of Hawaii issued an order limiting bars, restaurants and gyms to 50% capacity, with patrons required to wear masks at all times except when eating and drinking.

Ige also ordered that all social gatherings be limited to no more than 10 people indoors and 25 people outdoors.

Source: Voice of America

How Does FDA Approve Vaccines?

Three vaccines developed to prevent COVID-19 infections received emergency use authorization earlier this year, allowing nearly half the U.S. population to be fully vaccinated against the virus.

But while much of the population remains skeptical of vaccination, the U.S. Food and Drug Administration is working to fully approve, or license, the three vaccines.

Some experts say that this approval, which is a much longer and more complicated process, may encourage some skeptics to get vaccinated.

“We recognize that for some, the FDA approval of COVID-19 vaccines may bring additional confidence and encourage them to get vaccinated,” Dr. Peter Marks, the director of the Center for Biologics Evaluation and Research at the FDA, told VOA via email.

But experts have said repeatedly that the three vaccines — Pfizer, Moderna and Johnson & Johnson — had been declared safe and effective before they were authorized for emergency use.

“The full approval process has less to do with getting additional scientific evidence and more to do with some of the logistics,” said Dr. David Dowdy, an epidemiologist at the Bloomberg School of Public Health at Johns Hopkins University. He told VOA the process included steps such as specifying the labeling of the vaccine and the specific wording on packaging.

Currently, Pfizer and Moderna have each filed a biologics license application (BLA) — the last step to full approval — with the FDA. Johnson & Johnson said in a statement released earlier this year that it would apply “later in 2021.”

What is the normal FDA licensing process for vaccines?

After a vaccine is developed, drugmakers usually test them on animals and tissue samples in preclinical trials.

Once a vaccine passes these pretrials, it undergoes three phases of clinical trials in humans, each trial with an increased number of participants. During this monthslong period, FDA officials will monitor the progress of the trials, observe the vaccine’s long-term efficacy and look for rare side effects.

Only after these trials are completed can a drug company submit a biologics license application, the formal and final approval process for a vaccine.

Once this application is submitted, the FDA will review all information from the clinical trials and inspect every facility where the vaccine is made to ensure everything is in order.

How will the process for the COVID-19 vaccines be different?

Three COVID-19 vaccines have already been widely used throughout the U.S. and the world because they were given emergency use authorization.

Still, all vaccines must go through the process of full licensing, which can take years. The FDA has not specified how long this process will take but has said that the COVID-19 vaccines are being given “priority review.”

“Acknowledging the urgency related to the current state of the pandemic, we have taken an all-hands-on-deck approach, including identifying additional resources, such as personnel and technological resources from across the agency, and opportunities to reprioritize other activities, in order to complete our review to help combat this pandemic surge,” Marks said.

The FDA clarified that a “priority review designation” means it aims to fully license vaccines within six months of an application being filed, as opposed to the standard 10 months.

According to Dowdy, the only differences between licensing a COVID-19 vaccine versus previous vaccines will involve speed and manpower. Dowdy likened the process to getting a passport, saying that while passport processing can take months because of the volume of applications, people can apply to expedite the process. This does not make the process less rigorous; it just means that a certain application is moved to the front of the line.

“We’re not giving these vaccines a free pass just because they’re being manufactured in the midst of a pandemic. The goal is to try and expedite these processes as much as possible,” he said.

How is emergency use authorization different?

Three COVID-19 vaccines were granted emergency use authorization earlier this year. Such approval requires the same scientific evidence and number of clinical trials proving the safety and effectiveness of the vaccine, but it skips some steps and technicalities concerning labeling and distribution.

“Although an authorization is not an FDA approval, the FDA conducted a thorough scientific evaluation of each of the authorized vaccines and can assure the public and medical community that the vaccines meet FDA’s rigorous standards for safety, effectiveness and manufacturing quality,” an FDA official told VOA via email.

Experts stress that millions of people have received the vaccines and that data continue to support their safety and effectiveness against the coronavirus.

Source: Voice of America