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India's drug regulator on Tuesday allowed vaccine maker Serum Institute to enroll kids aged 7-11 years for its Covid-19 vaccine trial as the country prepares to protect children from the coronavirus.
"After detailed deliberation, the committee recommended for allowing enrolment of subjects of 7 to 11 years of age group as per the protocol," a subject&nbsp;expert panel of the Central Drugs Standard Control Organization said.
Serum Institute is already conducting a trial of its Covid-19 vaccine, which is a domestically produced version of US drugmaker Novavax's shot, in the 12-17 age group and has presented safety data for an initial 100 participants.
So far, only Zydus Cadila's DNA Covid-19 vaccine has received emergency use approval in India to be used in adults and children aged 12 years and above.
&nbsp;

Serum Institute gets nod to enroll kids aged 7 to 11 for Covid vaccine trials

Covid Vaccine for children: Serum Institute allowed to enroll kids aged 7 to 11 for Covid vaccine trials


Serum can enroll kids aged 7 to 11 for Covid vaccine trials

India's drug regulator on Tuesday allowed vaccine maker Serum Institute to enrol kids aged 7-11 years for its Covid-19 vaccine trial as the country prepares to protect children from the coronavirus.
Serum Institute is already conducting a trial of its Covid-19 vaccine, which is a domestically produced version of US drugmaker Novavax's shot, in the 12-17 age group and has presented safety data for an initial 100 participants.
So far, only Zydus Cadila's DNA Covid-19 vaccine has received emergency use approval in India to be used in adults and children aged 12 years and above.
&nbsp;

India's drug regulator on Tuesday allowed vaccine maker Serum Institute to enroll kids aged 7-11 years for its Covid-19 vaccine trial as the country prepares to protect children from the coronavirus

India's drug regulator on Tuesday allowed vaccine maker Serum Institute to enroll kids aged 7-11 years for its Covid-19 vaccine trial as the country prepares to protect children from the coronavirus.
"After detailed deliberation, the committee recommended for allowing enrolment of subjects of 7 to 11 years of age group as per the protocol," a subject&nbsp;expert panel of the Central Drugs Standard Control Organization said.
Also watch:&nbsp;<a title="Nearly 25% of India's adults fully vaccinated against Covid-19" href="https://www.editorji.com/india-news/nearly-25-of-india-s-adults-fully-vaccinated-against-covid-19-1632880555317">Nearly 25% of India's adults fully vaccinated against Covid-19</a>
Serum Institute is already conducting a trial of its Covid-19 vaccine, which is a domestically produced version of US drugmaker Novavax's shot, in the 12-17 age group and has presented safety data for an initial 100 participants.
So far, only Zydus Cadila's DNA Covid-19 vaccine has received emergency use approval in India to be used in adults and children aged 12 years and above.
&nbsp;

Austria, Germany, Slovenia, Greece, Iceland, Ireland and Spain are the seven EU member countries that accepted Covidshield vaccine on Thursday.

Covishield cleared by 8 EU nations for 'Green Pass'

Austria, Germany, Slovenia, Greece, Iceland, Ireland and Spain are the EU member countries that accepted Covishield vaccine on Thursday.

Covid-19: 8 European countries include Covishield in 'green pass'
India-made Covishield vaccine gets &lsquo;green pass&rsquo; in few European countries EU nations add SII&rsquo;s Covishield in Green Passport List
India reached out to EU for exemption on India-made vaccines

Austria, Germany, Slovenia, Greece, Iceland, Ireland and Spain are the EU member countries that accepted Covishield vaccine on Thursday.

Day after India formally requested European Union member states to include both Covishield&nbsp;and Covaxin&nbsp;in their exemption list for the passport, Switzerland and seven EU countries have added the Serum Institute-manufactured Oxford-Astrazeneca vaccine.
Austria, Germany, Slovenia, Greece, Iceland, Ireland and Spain are the seven EU member countries that accepted Covishield&nbsp;vaccine on Thursday. Earlier,&nbsp;India had reached out to member countries of the European Union, urging to list domestically-made coronavirus&nbsp;vaccines--Covaxin and&nbsp;Covishield on the national travel lists formed in the backdrop of the Covid crisis.&nbsp;

As the acute vaccine shortage continues across India, Bloomberg&nbsp;reports as per sources that the Modi-govt had only placed an order for 110 million vaccines from Serum since sales started in December. A 110 millon doses is only enough to cover 4% of India's eligible population for the inoculation drive.&nbsp;
Sources also told Bloomberg&nbsp;that&nbsp;Serum though is now getting many orders from states is facing difficulty keeping up as&nbsp;production facilities can produce only 60 to 70 million doses a month.
Serum, the world's largest vaccine manufacturer hopes to ramp up capacity to 100 million by July.&nbsp;

Govt places vaccine order till July but data shows Serum December order covered just 4% of people

Even as the central govt finally places vaccine&nbsp;orders for the next 3 months reports indicate that&nbsp;Modi-govt had only placed an order for 110 million vaccines from Serum since sales started in December. A 110 millon doses is only enough to cover 4% of India's eligible population for the vaccine drive.&nbsp;
&nbsp;

Serum Vaccine order covered just 4% of people

<ul>
<li>Modi&nbsp;govt only ordered 110 million doses from Serum: reports&nbsp;</li>
<li>Central govt order in December for vaccine = 4% of population: reports</li>
<li>Serum currently can produce only 60-70 million doses/month</li>
<li>Serum hoping to increase production to 110 million doses by July</li>
</ul>

As the acute vaccine shortage continues across India, Bloomberg&nbsp;reports as per sources that the Modi-govt had only placed an order for 110 million vaccines from Serum since sales started in December. A 110 millon doses is only enough to cover 4% of India's eligible population for the inoculation drive.&nbsp;
Sources also told Bloomberg&nbsp;that&nbsp;Serum though is now getting many orders from states is facing difficulty keeping up as&nbsp;production facilities can produce only 60 to 70 million doses a month.
Serum, the world's largest vaccine manufacturer hopes to ramp up capacity to 100 million by July.&nbsp;
The government however refuting it's laxity in ordering&nbsp;said it placed a third order last month for 160 million vaccine doses to be delivered over the following three months.&nbsp;
The Centre had on April 28 ordered 110 million doses of Covishield, made by Serum Institute of India (SII) and 50 million of Bharat Biotech&rsquo;s Covaxin to cover inoculations until July, the government said in a statement on Monday.
&nbsp;

Serum India told to halt recruitment for vaccine trials

India's drug regulator has directed Serum Institute of India to suspend recruitment of new volunteers for phase 2 and 3 clinical trials of the Oxford Covid-19 vaccine candidate

India's drug regulator has directed Serum Institute of India to suspend recruitment of new volunteers for phase 2 and 3 clinical trials of the Oxford Covid-19 vaccine candidate. The directive came in the backdrop of pharma giant AstraZeneca pausing the trials in other countries. The DCGI on Friday also directed Serum Institute to increase the safety monitoring of the subjects already vaccinated as part of the trial, and submit the plan and report. The drugmaker&nbsp;had on Thursday hit a pause after AstraZeneca put the trials on hold following an unexplained illness in a volunteer in the UK.

New Delhi, PTI: Drugs Controller General of India (DCGI) has directed Serum Institute of India to suspend till further orders new recruitment in phase 2 and 3 clinical trials of the Oxford Covid-19 vaccine candidate in the backdrop of pharma giant AstraZeneca pausing the trials in other countries.
In an order, a copy of which has been accessed by PTI, DCGI Dr V G Somani on Friday also directed Serum Institute of India (SII) to increase the safety monitoring of the subjects already vaccinated as part of the trial, and submit the plan and report.
Somani also asked the firm to submit clearance from Data and Safety Monitoring Board (DSMB) in the UK as well as in India to obtain clearance from his office (DCGI) prior to resumption of future recruitment in the trial. The central drug regulator DCGI had issued a show-cause notice to SII on September 9 for not informing it about AstraZeneca pausing clinical trials of the vaccine candidate in other countries and also for not submitting casualty analysis of the "reported serious adverse events".
Following which the Pune-based firm, which has partnered with the British-Swedish biopharmaceutical giant AstraZeneca for manufacturing the Oxford vaccine candidate, on Thursday said it is pausing the clinical trials in India.
Earlier this week, AstraZeneca said it had paused the trials because of 'an unexplained illness' in a participant in the study. "We are reviewing the situation and pausing India trials till AstraZeneca restarts the trials," SII said in a statement on Thursday. According to the DCGI's order issued on Friday, the SII in its reply stated that DSMB has noted no safety concerns from the Indian study (part 1-phase-2 study) with the first dose and seven days post vaccination safety data. In its reply, SII also stated that DSMB further recommended "to pause further enrolment into the study until ongoing investigations of SAE reported in the UK study is completed and the sponsor and the UK DSMB are satisfied that it doesn't pose any safety concerns".
"In the view of the above, I Dr V G Somani, Drugs Controller General of India, Central Licensing Authority, after careful examination of your reply and the recommendations of the DSMB in India, in exercise of the powers vested under Rule 30 of the New Drugs and Clinical Trials Rules, 2019, direct to you suspend any new recruitment in the phase 2 and 3 clinical trial till further orders," the order read.
"Increase the safety monitoring of the subjects already vaccinated with the vaccine under trial and submit the plan and report," the order further stated.

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