Coronavirus live updates | Covaxin’s launch in U.S. to be delayed after FDA requests additional data

The seven-day rolling average of daily vaccinations in the country stood at 30.27 lakh on June 10. The last time the figure had crossed the 30-lakh mark was nearly two months back, on April 17. Only 3.4% of the country’s population has received both doses, while 14.6% population has received at least the first shot of vaccine.

You can track coronavirus cases, deaths and testing rates at the national and State levels here. A list of State Helpline numbers is available as well.

Here are the latest updates:

Karnataka

A list of what is allowed in Bengaluru and what is not from June 14 to 21

While continuing the current lockdown restrictions in 11 districts that have high positivity rate for COVID-19, the Karnataka government on June 10 modified some of the restrictions imposed in other districts, including Bengaluru, from June 14 to 21.

• Shops related to food, groceries, fruits and vegetables, meat, fish and dairy will function from 6 a.m. to 2 p.m. Ration shops too will be open.
• Standalone liquor shops will be open from 6 a.m. to 2 p.m.
• Parks will be open from 5 a.m. to 10 a.m. for walking and jogging, but group activities are prohibited.
• Street vendors can carry out their business from 6 a.m. to 2 p.m.

Find the complete list here.

Karnataka

Expect restrictions till December: Experts

Although the second wave of COVID-19 appears to be subsiding, it is going to be a long wait for return of the pre-lockdown days in Karnataka, say experts. They warn that people will have to learn to live with some restrictions in place even beyond December.

The State’s COVID-19 Technical Advisory Committee (TAC), that has recommended staggered unlocking in its report submitted to the government, has made it clear that all social, political and religious gatherings, public rallies, sit-ins/dharnas, fairs and festivals should not be allowed in all of 2021. Besides, it has recommended that all elections that involve canvassing and rallies or any other super-spreading events should not be held in 2021.

Covaxin’s launch in U.S. to be delayed after FDA requests additional data

In a setback to Bharat Biotech’s COVID-19 vaccine Covaxin, the U.S. Food and Drug Administration has “ recommended” Ocugen Inc, the U.S. partner of the Indian vaccine maker, to go for Biologics Licence Application (BLA) route with additional data, nixing hopes of Emergency Use Authorisation.

Ocugen in a statement on Thursday announced that as recommended by the FDA,it will pursue submission of a biologics licence application (BLA) for Covaxin.

BLA is a “full approval” mechanism by the FDA for drugs and vaccines.

“The company will no longer pursue an Emergency Use Authorisation (EUA) for Covaxin. The FDA provided feedback to Ocugen regarding the Master File. The company had previously submitted and recommended that Ocugen pursue a BLA submission instead of an EUA application for its vaccine candidate and requested additional information and data,” Ocugen said.