Connect with us

Business

Guyanese scientist in Pfizer COVID vaccine team says it’s safe for use – Stabroek News

Published

 on


The rapid development of COVID-19 vaccines has caused much wariness and concern, but Guyanese-born scientist Vidia Roopchand, who is employed with Pfizer Inc is assuring that all safety standards were observed during the development of the Pfizer-BioNTech vaccine.

Roopchand is one of several scientists who were involved in the development of the Pfizer-BioNTech vaccine called BNT162b2.

The announcement of effective COVID-19 vaccines was a glimmer of hope to many but persons are unsure about the safety of the vaccination given its rapid development.

During an interview with Stabroek News earlier this month, Roopchand stated that the COVID-19 pandemic represents an unparalleled crisis in recent history and has been a challenge to science, but safety has always been the number one priority for Pfizer.

“Safety was, is, and will always be our number one priority in vaccine research and development. Even though we moved with extraordinary speed, high quality and safety standards were preserved throughout development. And as in all our work to advance investigational vaccines, we worked closely with clinical trial sites and experienced investigators and regulatory agencies worldwide. We took all of the regulatory and operational steps that we would normally take for all of our vaccine trials to maintain the highest standards in our development process and did not cut any corners. In addition, an independent safety data monitoring committee is in place to evaluate the safety of our vaccine candidate,” Roopchand assured.  

Roopchand noted that Pfizer and BioNTech began collaborating in 2018 to develop a vaccine for influenza and extended the collaboration in March 2020 with the launch of “Project Lightspeed” to develop a vaccine for COVID-19.

He disclosed that the Phase 1 clinical trials began in the US and Germany in April and were designed to evaluate the safety, tolerability, and potential efficacy of up to four mRNA vaccine candidates and to select which vaccine candidate and dose should be taken forward for future clinical study.

One vaccine candidate – BNT162b2, was selected for the phase 3 clinical trial, which began in July with more 44,000 participants. He added that the final efficacy analysis in the ongoing Phase 3 study demonstrated a vaccine efficacy rate of 95% in participants without prior COVID-19 infection and also in participants with prior COVID-19 infection. He noted that the effectiveness of the vaccine was consistent across age, gender, race and ethnicity demographics. “The observed efficacy in adults over 65 years of age was over 94%,” he said. He added that BNT162b2 was selected based on an extensive review of preclinical and clinical data from Phase 1 and 2 clinical trials.

In addition, he said, the Pfizer-BioNTech team accelerated the development process by doing some operational steps in parallel rather than sequentially as would normally be done. He explained that the investigator site selection process began earlier than normal and more persons were employed to give operations the support and flexibility needed. He added that they also invested upfront in certain areas, such as manufacturing, in order to be ready to execute as decisions were made.  

Further, he noted that in the usual drug development journey, the process of preparing regulatory data packages to submit to the FDA and waiting for its response often takes months but due to the fact that COVID-19 is a global pandemic, regulators have responded to the data very quickly to help keep trials running as quickly as possible.

“When COVID-19 emerged, it was a logical step for BioNTech and Pfizer to collaborate in this effort. The BioNTech and Pfizer scientists worked in close collaboration to design BNT162b2 which eventually became the vaccine.

I led the cell culture group to provide the cells which were used to confirm that the m-RNA was expressing the correct protein. I also assisted with some of the immunological assays to evaluate the response in the preclinical studies,” he added.

Meanwhile, it was revealed that data from this study, including longer term safety, comprehensive information on duration of protection, efficacy against asymptomatic SARS-CoV-2 infection, and safety and immunogenicity in adolescents 12 to 17 years of age, will be gathered in the upcoming months.

Additional studies are planned to evaluate BNT162b2 in pregnant women, children younger than 12 years, and those in special risk groups, such as the immunocompromised.

Roopchand added that persons who receive the Pfizer-BioNTech COVID-19 vaccine are encouraged to continue to take all COVID-19 safety precautions.

It is yet to be determined the duration of immunity after immunization with an effective COVID-19 vaccine.

Based on evidence from clinical trials, Pfizer-BioNTech said that the vaccine they have developed is 95% effective at preventing laboratory-confirmed COVID-19 illness in people without evidence of previous infection. Several countries including the United Kingdom and the United States have since approved the Pfizer vaccine for emergency use.

According to Health Minister Dr Frank Anthony, Guyana will be accessing a COVID-19 vaccine for three per cent of its population through COVAX.

However, as of now it is uncertain when or which COVID-19 vaccine will be accessed by Guyana although it was suggested that the vaccine will be made available to Guyana in the second quarter of the New Year. Nevertheless, Anthony said that preparatory steps are underway to ensure that the country is ready for a vaccine when it becomes available.

Let’s block ads! (Why?)



Source link

Continue Reading

Business

Retail frenzy as restrictions eased – Winnipeg Free Press

Published

 on



Hundreds of Winnipeggers lined up outside multiple retailers across the city, with one shopper bellowing triumphantly: “It doesn’t even feel like a pandemic anymore — it’s Boxing Day 2.0!”

As the province eased public-health orders to allow the sale of non-essential items this weekend, parking lots filled up quickly Saturday morning.

Shoppers didn’t let the biting snow showers or even the mandated 25-per-cent capacity limits stop them from waiting outside storefronts for hours on end, before they could get in. Malls remained busy well into the evening, with larger outlets allowing up to 250 people at a time.

“Honestly,” Darrien Drewyer told the Free Press, as he queued up outside the Winnipeg IKEA with his young son to pick up a new chair, “I’ve been waiting for this for like months now.”

Drewyer — like all of Manitoba — hasn’t been able to shop for anything but groceries, pharmaceuticals or other essentials since mid-November, when the province enforced strict Code Red measures to curb the spread of COVID-19.

At Polo Park, a security guard said he’d never seen this many cars stacked across the space in tight rows in the many years he’s worked at the mall. “It’s madness,” he said.

“We couldn’t do a lot of Christmas shopping or even Boxing Day or Black Friday properly,” said Nicole Julien, waiting outside the Grant Park Winners outlet.

“I guess this is our chance now because the government finally said you can do it,” chimed in Julien’s boyfriend Henry Siloam, who wanted to purchase a pair of T-shirts he saw at a special in-store discount.

While most other large retailers, such as Costco, Toys”R”Us, Best Buy and Sport Chek were also chock full of customers, independent and small stores did not see the same level of foot traffic.

Just a few steps next to the busy Winners outlet in Grant Park Shopping Centre, which touts up to 70 different storefronts, Northern Reflections and other such outlets appeared barren.

Used DVD store Entertainment Exchange was relatively occupied with customers, however. At one point Saturday afternoon, at least 12 people were waiting to enter, while several others were already glancing over the CDs inside.

“I’m sure the larger businesses are extremely happy with this,” said Jonathan Alward, Manitoba director for the Canadian Federation of Independent Business. “But I just wish people would understand that it might actually be safer and even quicker to go support a small business instead of going off to an IKEA instantly.”

Alward hopes, “once people have gotten things out of their system in the following days,” retailers could look calmer. He thinks a lot of it comes from having more than two months of pent-up cabin fever since restrictions were implemented.

According to the newly relaxed public-health orders, all businesses are allowed to reopen and sell anything they’d like, if they’re enforcing strict capacity limits, physical distancing guidelines and mask policies. Restrictions have not been eased for northern Manitoba communities.

The new rules have effectively closed all loopholes that emerged from a repeatedly changed provincial list of “essential” items, which advocates and business owners have argued impacted independent companies more than big-box stores. Smaller shops relied far more on curbside pickups, delivery and online sales — without necessarily having the infrastructure to match larger chains.

Announcing the measures Thursday, chief public health officer Dr. Brent Roussin said the new rules are meant to “allow increased personal connections, support the well-being of Manitobans… and allow struggling small businesses to get a chance at opening.”

“It all depends on Manitobans,” said Roussin of the current orders that will last at least three weeks. “If we start seeing transmission of COVID-19 again, we’re not going to be able to further reopen.”

Looking at the lineups across the provincial capital on the first day of reopenings, Lisa Malbranck of Diamond Gallery isn’t sure if that messaging has come across for Manitobans.

“You know, they’ve talked so much about this ‘spirit’ of the orders,” she said Saturday. “To me this doesn’t really seem like the spirit of the order when you’re running off and flocking so quickly to the bigger stores.”

At her own store, Malbranck did not see any lineups. Save for the occasional walk-in customers, most people came in after they’d already booked an appointment.

“At the end of the day,” she said, “I just want our community to come together and support the ones these orders are really there for, as we return to some sense of normal again.”

Twitter: @temurdur

Temur.Durrani@freepress.mb.ca

Temur Durrani

Temur Durrani
Reporter

Temur Durrani reports on the economic impact of the coronavirus pandemic for the Winnipeg Free Press. Funding for this Free Press reporting position comes from the Government of Canada through the Local Journalism Initiative.

   Read full biography

Let’s block ads! (Why?)



Source link

Continue Reading

Business

Retail frenzy as restrictions eased – Winnipeg Free Press

Published

 on



Hundreds of Winnipeggers lined up outside multiple retailers across the city, with one shopper bellowing triumphantly: “It doesn’t even feel like a pandemic anymore — it’s Boxing Day 2.0!”

As the province eased public-health orders to allow the sale of non-essential items this weekend, parking lots filled up quickly Saturday morning.

Shoppers didn’t let the biting snow showers or even the mandated 25-per-cent capacity limits stop them from waiting outside storefronts for hours on end, before they could get in. Malls remained busy well into the evening, with larger outlets allowing up to 250 people at a time.

“Honestly,” Darrien Drewyer told the Free Press, as he queued up outside the Winnipeg IKEA with his young son to pick up a new chair, “I’ve been waiting for this for like months now.”

Drewyer — like all of Manitoba — hasn’t been able to shop for anything but groceries, pharmaceuticals or other essentials since mid-November, when the province enforced strict Code Red measures to curb the spread of COVID-19.

At Polo Park, a security guard said he’d never seen this many cars stacked across the space in tight rows in the many years he’s worked at the mall. “It’s madness,” he said.

“We couldn’t do a lot of Christmas shopping or even Boxing Day or Black Friday properly,” said Nicole Julien, waiting outside the Grant Park Winners outlet.

“I guess this is our chance now because the government finally said you can do it,” chimed in Julien’s boyfriend Henry Siloam, who wanted to purchase a pair of T-shirts he saw at a special in-store discount.

While most other large retailers, such as Costco, Toys”R”Us, Best Buy and Sport Chek were also chock full of customers, independent and small stores did not see the same level of foot traffic.

Just a few steps next to the busy Winners outlet in Grant Park Shopping Centre, which touts up to 70 different storefronts, Northern Reflections and other such outlets appeared barren.

Used DVD store Entertainment Exchange was relatively occupied with customers, however. At one point Saturday afternoon, at least 12 people were waiting to enter, while several others were already glancing over the CDs inside.

“I’m sure the larger businesses are extremely happy with this,” said Jonathan Alward, Manitoba director for the Canadian Federation of Independent Business. “But I just wish people would understand that it might actually be safer and even quicker to go support a small business instead of going off to an IKEA instantly.”

Alward hopes, “once people have gotten things out of their system in the following days,” retailers could look calmer. He thinks a lot of it comes from having more than two months of pent-up cabin fever since restrictions were implemented.

According to the newly relaxed public-health orders, all businesses are allowed to reopen and sell anything they’d like, if they’re enforcing strict capacity limits, physical distancing guidelines and mask policies. Restrictions have not been eased for northern Manitoba communities.

The new rules have effectively closed all loopholes that emerged from a repeatedly changed provincial list of “essential” items, which advocates and business owners have argued impacted independent companies more than big-box stores. Smaller shops relied far more on curbside pickups, delivery and online sales — without necessarily having the infrastructure to match larger chains.

Announcing the measures Thursday, chief public health officer Dr. Brent Roussin said the new rules are meant to “allow increased personal connections, support the well-being of Manitobans… and allow struggling small businesses to get a chance at opening.”

“It all depends on Manitobans,” said Roussin of the current orders that will last at least three weeks. “If we start seeing transmission of COVID-19 again, we’re not going to be able to further reopen.”

Looking at the lineups across the provincial capital on the first day of reopenings, Lisa Malbranck of Diamond Gallery isn’t sure if that messaging has come across for Manitobans.

“You know, they’ve talked so much about this ‘spirit’ of the orders,” she said Saturday. “To me this doesn’t really seem like the spirit of the order when you’re running off and flocking so quickly to the bigger stores.”

At her own store, Malbranck did not see any lineups. Save for the occasional walk-in customers, most people came in after they’d already booked an appointment.

“At the end of the day,” she said, “I just want our community to come together and support the ones these orders are really there for, as we return to some sense of normal again.”

Twitter: @temurdur

Temur.Durrani@freepress.mb.ca

Temur Durrani

Temur Durrani
Reporter

Temur Durrani reports on the economic impact of the coronavirus pandemic for the Winnipeg Free Press. Funding for this Free Press reporting position comes from the Government of Canada through the Local Journalism Initiative.

   Read full biography

Let’s block ads! (Why?)



Source link

Continue Reading

Business

Vaccine eligibility spurs frustration as youngest Albertan, 20, dies of COVID-19 – Calgary Herald

Published

 on


Article content continued

Through Friday, Alberta has administered 98,807 doses of COVID-19 vaccine, including at least 8,304 second doses. It’s an increase of only 1,022 shots from the previous day, a slowdown caused by short supply from a disruption to Pfizer shipments.

On Saturday, the province reported 573 new cases of the novel coronavirus. The infections came from 10,894 tests, representing a 5.3 per cent positivity rate and breaking a three-day streak of positivity rates below five per cent.

Also Saturday, Alberta reported 13 additional deaths from COVID-19, bringing the pandemic’s toll in the province to 1,525.

Two of those deaths were people in their 20s from the Alberta Health Services Calgary zone, a man and a woman. According to Alberta Health, it’s unknown whether the man had any comorbidities, but the woman did not.

One of the newly reported deaths was 20 years old, the youngest Albertan to die of COVID-19. Previously, the youngest person reported to have died from the virus was 23. Seven Albertans in their 20s and another seven in their 30s have lost their lives to the virus.

Hospitalization rates continued a steady decline Saturday. There are now 676 Albertans in hospital with the coronavirus, including 114 in intensive-care units.

The number of active cases in Alberta also dropped to 9,727. The province dipped below 10,000 active cases the previous day for the first time since November.

jherring@postmedia.com

Twitter: @jasonfherring

Let’s block ads! (Why?)



Source link

Continue Reading

Trending