New York: Pfizer Inc and BioNTech SE on Monday said their vaccine candidate was found to be more than 90 percent effective in preventing COVID-19.
"Today is a great day for science and humanity. The first set of results from our Phase 3 COVID-19 vaccine trial provides the initial evidence of our vaccine's ability to prevent COVID-19," Pfizer Chairman and CEO Albert Bourla said.
"We are reaching this critical milestone in our vaccine development program at a time when the world needs it most with infection rates setting new records, hospitals nearing over-capacity, and economies struggling to reopen," he added.
After a discussion with the Food and Drug Administration (FDA), the companies recently elected to drop the 32-case interim analysis and conduct the first interim analysis at a minimum of 62 cases, the statement said.
"... we are a significant step closer to providing people around the world with a much-needed breakthrough to help bring an end to this global health crisis. We look forward to sharing additional efficacy and safety data generated from thousands of participants in the coming weeks," Bourla said.
BioNTech co-founder and CEO Ugur Sahin said: "The first interim analysis of our global Phase 3 study provides evidence that a vaccine may effectively prevent COVID-19. This is a victory for innovation, science, and a global collaborative effort."
"Especially today, while we are all in the midst of a second wave and many of us in lockdown, we appreciate even more how important this milestone is on our path towards ending this pandemic and for all of us to regain a sense of normality," he added.
The Phase 3 clinical trial of BNT162b2 began on July 27 and has enrolled 43,538 participants to date, 38,955 of whom have received a second dose of the vaccine candidate as of November 8, 2020, the statement said.
The trial is continuing to enroll and is expected to continue through the final analysis when a total of 164 confirmed COVID-19 cases have accrued.
The study also will evaluate the potential for the vaccine candidate to provide protection against COVID-19 in those who have had prior exposure to SARS-CoV-2, as well as vaccine prevention against severe COVID-19 disease, it added.
"Pfizer and BioNTech are continuing to accumulate safety data and currently estimate that a median of two months of safety data following the second (and final) dose of the vaccine candidate - the amount of safety data specified by the FDA in its guidance for potential Emergency Use Authorization - will be available by the third week of November," the statement said.
Based on current projections, the companies expect to produce globally up to 50 million vaccine doses in 2020 and up to 1.3 billion doses in 2021, it added.
The companies also plan to submit data from the full Phase 3 trial for scientific peer-review publication, the statement said.
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New Delhi (PTI) A day after a 50 per cent rise in commercial LPG cylinder prices, Delhi's food business, with restaurant owners and street vendors have warned of higher menu rates, financial strain and potential job losses if the trend persists.
The price of commercial LPG was hiked by a steep Rs 993 per 19 kg cylinder, marking the third consecutive monthly hike amid rising global energy prices linked to the West Asia conflict.
For many in the restaurant industry, the spike has been both sudden and steep.
Manpreet Singh, honorary treasurer of the National Restaurant Association of India, said that eateries are already grappling with supply challenges alongside rising costs.
"There is a huge difficulty in getting these cylinders, and black marketing is also increasing in many unregulated sectors," he said, noting that prices that were once around Rs 1,600, often dropping to nearly Rs 1,300 with discounts, have now surged to between Rs 3,000 and Rs 4,000 per cylinder.
He further added that a medium-sized restaurant typically uses between two and five cylinders daily, making the increase particularly burdensome as costs mount.
Singh further said that as costs mount, smaller establishments could struggle to stay afloat. Instead, the association has advised restaurants to shift towards piped natural gas connections through Indraprastha Gas Limited as a more sustainable alternative.
"If this problem continues, PNG is the only long-term solution," he said, adding that temporary measures like coal offer limited relief due to slower cooking times and that it can largely be used only for tandoors.
Echoing similar concerns, Kabir Suri, owner of Mamagoto in Khan Market, said the impact is already visible across the industry. "There has been almost a threefold increase in cylinder prices for restaurants," he said, adding that rising fuel and logistics costs are compounding the pressure.
"If this continues, it will become a significant financial burden, and food prices will inevitably go up. Adding to this burden, higher fuel costs are also affecting logistics and transportation, making a price rise unavoidable. The extent of the impact will vary between small eateries and large chains depending on their scale," he said.
Global oil prices have surged nearly 50 per cent following disruptions in energy supply chains due to the West Asia conflict, pushing up commercial fuel costs and transport expenses.
A West Delhi-based restaurateur said they are trying to manage rising costs while keeping their staff secure. "We are trying to ensure that our staff, from kitchen workers to waiters, are paid on time and do not face immediate hardship," the owner said.
"We are a small restaurant with seating for about 20 to 25 people at a time. But if this continues for long, we will have to take difficult calls. There is only so much we can absorb, and menu prices will have to go up. We hope this does not continue for a longer period," he said.
Another restaurant owner in North Delhi, who did not wish to be named, said operational adjustments alone may not be enough. "We are checking our costs very carefully and trying to cut wherever possible, but if fuel prices remain high, it will eventually affect how we run the business," the owner said.
"Coal helps in tandoor cooking, but it takes more time," the owner further added.
The strain is even more acute among street vendors, many of whom operate on thin margins. A vendor in Saket said he had recently expanded his business, moving from a mobile cart to a rented outlet.
"I have a family to feed and more responsibilities now. Earlier, I managed with a moving cart, but after renting the place, expenses increased," he said. "Whenever cylinders were unavailable, I had to buy them at higher rates in the black market. Now even regular supply is too expensive, and if this continues, we may have to shut down," he added.
In Laxmi Nagar, another vendor said they are struggling to keep the business running. "Sometimes we even used domestic cylinders from home when supply ran out because we had to keep the stall running," he said, adding that rising costs leave little choice but to increase prices or bear losses.
On April 1, the rates of commercial LPG cylinders were hiked by Rs 195.50 per cylinder, followed by a Rs 114.5 hike on March 1, taking the total increase over the past three months to Rs 1,303. With the latest revision, a 19 kg commercial LPG cylinder now costs Rs 3,371.5 in Delhi, up from Rs 2,078.5 earlier.
The prices of domestic LPG cylinders used for household cooking have remained unchanged. They were last increased by Rs 60 per 14.2 kg cylinder on March 7 and currently cost Rs 913 in Delhi.
