#covovax trial start

[tezlivenews]

कोरोना वैक्सीन कोवोवैक्स का बच्चों पर परीक्षण, 02-17 उम्र के वॉलिंटियर्स की भर्ती शुरू

कोरोना वैक्सीन कोवोवैक्स का बच्चों पर परीक्षण, 02-17 उम्र के वॉलिंटियर्स की भर्ती शुरू

नयी दिल्लीहमदर्द चिकित्सा विज्ञान एवं अनुसंधान संस्थान में दो से 17 वर्ष की आयु के बच्चों के बीच कोविड-19 रोधी टीके कोवोवैक्स के तीन चरणों में से दूसरे चरण के नैदानिक परीक्षण के लिए स्वयंसेवियों की भर्ती रविवार को शुरू हुई। आधिकारिक सूत्रों के अनुसार यह परीक्षण 10 स्थानों पर होगा और इसमें 920 बच्चे शामिल होंगे जिनमें 12-17 और 2-11 आयु वर्ग में 460-460 बच्चे शामिल होंगे। कुछ शर्तों के साथ परीक्षण…

[newsmatters]

Serum institute to start clinical trials of Novavax for children in July

Serum institute to start clinical trials of Novavax for children in July

Image Source : AP The government had said the efficacy data of Novavax vaccine against Covid-19 is promising If reports are to be believed, the Serum Institute of India is planning to start clinical trials of the Novavax shot for children in July. The US-based biotechnology company Novavax has tied up with the Serum Institute of India (SII) to manufacture its Covid-19 vaccine, namely Covovax.…

[thedepthnews]

कोरोना वायरस की नई वैक्सीन ''Covovax'' का फाइनल ट्रायल इसी महीने होगा शुरू - कोरोना वायरस की वैक्सीन कोवोवैक्स (Covovax) का दूसरे और तीसरे फेज ट्रायल करने की तैयारी शुरू हो चुकी है। इसका ट्रायल इंडियन काउंसिल ऑफ मेडिकल रिसर्च (ICMR) और सीरम इंस्टीट्यूट ऑफ इंडिया (SII) कर रहे हैं। SII ने अपनी दूसरी वैक्सीन कोवोवैक्स को डेवेलप करने के लिए नोवावैक्स के साथ https://thedepth.in/serum-institute-of-india-will-start-trial-of-second-corona-vaccine-in-may/

[newsindiaguru]

Serum Institute to start phase 3 trials of COVID-19 vaccine Covovax by mid-May

Serum Institute to start phase 3 trials of COVID-19 vaccine Covovax by mid-May

नई दिल्ली: सीरम इंस्टीट्यूट ऑफ इंडिया द्वारा COVID-19 वैक्सीन कोवॉक्स के 3 चरण शुरू किए जाने की संभावना है, जिसे वह अमेरिकी कंपनी नोवावैक्स के साथ साझेदारी में बना रही है। ड्रग्स कंट्रोलर जनरल ऑफ इंडिया ने अगले चरण के परीक्षणों के लिए जाने की अपनी मंजूरी प्रदान कर दी है। Covovax के बाद दूसरा टीका उम्मीदवार है Covishield कि SII निर्माण कर रहा है। डेटा सुरक्षा निगरानी बोर्ड ने कोवॉक्स के चरण -2…

[tachtutor]

Serum Institute starts trial for 2nd Covid-19 vaccine ‘Covavax’

Serum Institute starts trial for 2nd Covid-19 vaccine ‘Covavax’

Serum Institute of India CEO Adar Poonawalla today tweeted that the trial for their second Covid-19 vaccine “Covovax” already commenced and his company hopes to launch it by September this year. The trials of “Covovax,” made by Serum and US vaccine development company Novavax, began at a hospital in the western Indian city of Pune yesterday, Poonawalla said. “Covovax trials finally begin in…

[globalexpressnews]

Serum Institute plans to launch yet another COVID-19 drug 'Covovax' by June

Serum Institute plans to launch yet another COVID-19 drug 'Covovax' by June

Mumbai: The world’s biggest vaccine producer Serum Institute of India (SII) on Saturday announced that it was hopeful to launch Covovax – developed in partnership with American vaccine developer Novavax – by June this year. After developing Covishield, SII CEO Adar Poonawalla said his company has applied to start the trials of Covovax. “Our partnership for a COVID 19 vaccine with @Novavax has…

[sachkiawaaj]

Serum Institute of India plans to launch Covovax by June: Adar Poonawalla

Serum Institute of India plans to launch Covovax by June: Adar Poonawalla

PUNE: In what could be a mega boost to the ongoing Covid-19 vaccination drive in India, the Serum Institute of India (SII) has announced its plan to launch its new vaccine, Covovax, by June this year. SII CEO Adar Poonawalla said on Saturday that its partnership for a Covid-19 vaccine with Novavax has shown excellent efficacy results. “We have applied for starting trials in India. Hope to launch…

[phgq]

Informed consent needed to get inoculated against Covid-19: DOH

#PHnews: Informed consent needed to get inoculated against Covid-19: DOH

MANILA – While prioritizing front-line workers, the elderly, and indigents with the limited doses of coronavirus disease 2019 (Covid-19) vaccine initially coming to the country starting next month, an informed consent would be needed to get inoculated against the deadly virus, a health official said Tuesday.

"Ang ating agreement diyan, and as recommended by our experts, mayroon naman ho kasi tayong informed consent. So, wala ho tayong maba-violate doon po sa mga karapatan ng ating mga kababayan (Our agreement on that, and as recommended by our experts, we have an informed consent. So, we won't violate any of our fellowmen's rights)," Health Undersecretary Maria Rosario Vergeire said during a televised Palace briefing.

Vergeire was responding to a question if an individual is allowed to refuse getting shots of Covid-19 vaccine.

She explained that individuals will be informed about the type of vaccine - including its benefits and side effects - before they sign the consent form for Covid-19 vaccination.

Choosing not to be inoculated with Covid-19 for whatever reason does not disqualify a person from being vaccinated in the future, she added.

"Ilalagay lang ho sila sa (Their names will just be placed at the) bottom list so that the other individuals can receive the vaccine," Vergeire said.

She emphasized that any kind of vaccine entering the country is scrutinized by the Food and Drug Administration (FDA) to ensure its efficacy and safety for public use.

"Basta nabigyan na po ng Emergency Use Authorization (EUA) ng FDA of the Philippines, equal footing na po iyan. Kaya hindi po natin kailangan na mamili po tayo ng bakuna. Kung ano po iyong mauunang bakuna, atin pong tanggapin iyan (If it's given Emergency Use Authorization by the FDA of the Philippines, that's equal footing. So, we don't need to choose. We'll receive which ever vaccine comes first)," she said. "Tandaan po natin iyong objective ng gobyerno kung bakit tayo kumukuha ng bakuna ay para maibsan na po natin itong sitwasyon natin ngayon (Let's remember that the objective of the government is to relieve our present situation that's why we are procuring vaccines)," she added.

On Monday, Presidential Spokesperson Harry Roque said the first 50,000 of the 25 million doses of China’s Sinovac vaccine will arrive in February aside from 15,000 doses to be used for clinical trials in the country.

Meanwhile, the delivery of 30 million doses of the Covovax vaccine from India will begin in the third quarter of the year.

The healthcare workers, senior citizens, and the indigent population constitute the sectors to be prioritized in the deployment of the Covid-19 vaccines. (PNA)

***

References:

* Philippine News Agency. "Informed consent needed to get inoculated against Covid-19: DOH." Philippine News Agency. https://www.pna.gov.ph/articles/1127178 (accessed January 13, 2021 at 05:28AM UTC+14).

* Philippine News Agency. "Informed consent needed to get inoculated against Covid-19: DOH." Archive Today. https://archive.ph/?run=1&url=https://www.pna.gov.ph/articles/1127178 (archived).

[phgq]

Delivery of 30M Covovax doses to PH starts in Q3 of 2021

#PHnews: Delivery of 30M Covovax doses to PH starts in Q3 of 2021

MANILA – The delivery of 30 million doses of the Covid-19 vaccine Covovax to the country will begin in the third quarter of the year, Fabreco Life Institutes Medical Director Dr. Luningning Villa said on Monday.

In virtual Palace presser, Villa said the delivery will start “within” July, August and September.

"More or less five to six months, matagal na po siguro 'yung six months na makumpleto po iyong (six months would be the maximum period to complete the) delivery," Villa added.

Fabreco Life Institutes is the local partner of Serum Institute of India (SII) which is the world’s largest vaccine manufacturer.

SII and Novavax, a US-based biotechnology company, have partnered to develop and commercialize the Covovax vaccine.

Through vaccine czar Carlito Galvez Jr., the government has signed a term sheet for the supply of the 30 million Covavax vaccine doses.

Covavax is in Phase 3 clinical trials and is expected to be approved for use by international regulators.

"We hope to have the EUA (emergency use authorization). Most likely, the United Kingdom will go first because they will finish the clinical trial first," Villa said. "And of course, with that, with the results of the Phase 3, we'll have hopefully EUA here in the Philippines by the FDA (Food and Drug Administration), of course with their evaluation.”

Covovax, Villa noted, is stable at 2°C to 8°C which is the standard temperature that is within the existing cold chain system in the country.

"Kahit doon sa malalayong baranggay na may health facility na magkakaroon ng vaccination, kayang-kaya po, stable pa rin po ang Covavax (Even if in the remotest barangays with health facility that will have vaccination, it can be used, the Covavax is still stable)," she said.

Apart from Covavax, the country has also secured 25 million doses of Sinovac vaccines and 2.6 million doses of vaccine from AstraZeneca which are expected to arrive in the second quarter of the year.

During the same Palace briefing, Presidential Spokesperson Harry Roque said the first 50,000 doses of China’s Sinovac vaccine will arrive in February aside from 15,000 doses to be used for clinical trials in the country.

“At least, by February, 65,000 na ang mabibigyan ng bakuna (But at least, 65,000 will be inoculated by February),” he said.

He said the delivery of 25 million doses of Sinovac vaccines is expected to be completed by December this year.

The government has also been negotiating other pharmaceutical companies including Pfizer, Johnson & Johnson, and Gamaleya Institute. (PNA)

***

References:

* Philippine News Agency. "Delivery of 30M Covovax doses to PH starts in Q3 of 2021." Philippine News Agency. https://www.pna.gov.ph/articles/1127050 (accessed January 12, 2021 at 04:07AM UTC+14).

* Philippine News Agency. "Delivery of 30M Covovax doses to PH starts in Q3 of 2021." Archive Today. https://archive.ph/?run=1&url=https://www.pna.gov.ph/articles/1127050 (archived).

[phgq]

PH signs deal to secure 30M doses of Covovax

#PHnews: PH signs deal to secure 30M doses of Covovax

MANILA – The Philippine government, represented by vaccine czar Secretary Carlito Galvez Jr., Serum Institute of India (SII), and Faberco Life Sciences, Inc. signed a term sheet on Saturday to secure 30 million doses of Covid-19 vaccine Covovax that will be available starting third quarter of this year.

“This is a significant milestone in relations between India and the Philippines. It shows that we don’t have to look far beyond Philippine shores to find friends who are willing to help each other out,” said Kishore Hemlani, founder of Faberco Life Sciences Inc., SII’s Philippine partner, after the signing with Galvez.

SII, the world’s largest vaccine manufacturer, partnered with Novavax, a US-based biotechnology company for the development and commercialization of the Covovax vaccine.

The vaccine has the recombinant coronavirus spike protein nanoparticle and a Novavax-patented Matrix-M adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies.

Covovax is in third-stage trials and expected to be approved for use by international regulators. 

“The vaccine will be used to vaccinate 15 million vulnerable and poor Filipinos. The vaccine is stable at 2°C to 8°C, the standard temperature that is within the existing cold chain system in the Philippines, thus allowing its distribution to the remotest barangays,” said Faberco Life Sciences medical director Luningning Villa.

The candidate vaccine is thoroughly evaluated in different geographies, various age groups, groups that are most affected by Covid-19, including people living with HIV, and racial and ethnic minorities.

The clinical trials involve a sizeable population of around 50,000 subjects to ensure extreme robust clinical data prior to approval by relevant regulatory bodies including the World Health Organization.

The vaccine underwent the initial phase of the clinical trials in Australia, South Africa and India.

Phase three trial is currently carried out in the United Kingdom with 15,000 subjects and also ongoing in the United States and Mexico with 30,000 subjects.

The price of the vaccine is expected to be finalized soon between the government and SII, which is noted for providing effective, safe and affordable vaccines across the globe through the decades.

Faberco Life Sciences, Inc., is also SII’s partner for key programs in the country such as the inactivated polio vaccine, rotavirus vaccine, pneumococcal conjugate vaccine, aside from the Covid-19 vaccine. (PR)

***

References:

* Philippine News Agency. "PH signs deal to secure 30M doses of Covovax." Philippine News Agency. https://www.pna.gov.ph/articles/1126945 (accessed January 11, 2021 at 07:19AM UTC+14).

* Philippine News Agency. "PH signs deal to secure 30M doses of Covovax." Archive Today. https://archive.ph/?run=1&url=https://www.pna.gov.ph/articles/1126945 (archived).