EU criticizes UK’s fast approval of Pfizer vaccine against COVID-19

 

BRUSSELS, DEC 2 – The EU criticized the UK’s rapid approval of the COVID-19 vaccine developed by Pfizer and BioNTech. The European Medicines Agency said its approval procedure is “more thorough”.

The UK has become the first country to approve Pfizer’s COVID vaccine and will start vaccinating next week. The decision was made in an ultra-fast approval process, which allowed the UK drug regulator to temporarily authorize the vaccine just ten days after it began examining data from large-scale studies.

In a statement, the European Medicines Agency (EMA), which handles the approval of COVID-19 vaccines for the EU, said its longer approval procedure is more appropriate because it is based on more evidence and requires more controls. than the procedure chosen by the United Kingdom.

The EMA also said it would make a decision by December 29. A European Commission spokesman said the EMA procedure is “the most effective regulatory mechanism to give all EU citizens access to a safe and effective vaccine”.

June Raine, head of the UK Medicines and Medicines Regulatory Agency (MHRA), defended the decision and said that “the way the MHRA has been conducted is equivalent to all international standards”.

EU parliamentarians have been even more explicit in their criticisms of Britain’s action. “I think this decision is problematic and I recommend that EU member states not repeat the process in the same way,” said Peter Liese, an EU parliamentarian who is a member of German Chancellor Angela Merkel’s party.

Reuters reminds that according to EU rules, the Pfizer vaccine must be authorized by the EMA, but EU countries can use an emergency procedure. The UK is still subject to EU rules until it leaves the EU bloc for good at the end of the year.

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COURTESY universul.net

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UK approves Pfizer-BioNTech vaccine for rollout from 'next week'

 

The vaccine also has been tested in only a small number of children, none younger than 12, and there is no information on its effects in pregnant women

Pfizer and BioNTech say they've won permission on Wednesday for emergency use of their Covid-19 vaccine in Britain, the world's first coronavirus shot that's backed by rigorous science — and a major step toward eventually ending the pandemic.

The move makes Britain one of the first countries to begin vaccinating its population as it tries to curb Europe's deadliest Covid-19 outbreak.

Health Secretary Matt Hancock said the programme would begin early next week. Hospitals, he said, were already ready to receive it.

“It is very good news,” Hancock said.

Other countries aren't far behind: The US and the European Union also are vetting the Pfizer shot along with a similar vaccine made by competitor Moderna Inc.

British regulators also are considering another shot made by AstraZeneca and Oxford University.

British media have reported that hospitals in England have been told to get ready to start doing vaccinations for medical workers as early as next week.

Pfizer said it would immediately begin shipping limited supplies to the UK — and has been gearing up for even wider distribution if given a similar nod by the US Food and Drug Administration, a decision expected as early as next week.

But doses everywhere are scarce, and initial supplies will be rationed until more is manufactured in the first several months of next year.

Pfizer CEO Albert Bourla called the UK decision a historic moment.

"We are focusing on moving with the same level of urgency to safely supply a high-quality vaccine around the world," Bourla said in a statement.

While the UK has ordered enough Pfizer vaccine for 20 million people, its not clear how many will arrive by year's end. Adding to the distribution challenges, the Pfizer vaccine must be stored at ultra-cold temperatures. Two doses three weeks apart are required for protection.

The UK government says frontline health care workers and nursing home residents will be first in line to get vaccinated, followed by older adults.

But UK Prime Minister Boris Johnson has warned "we must first navigate a hard winter of restrictions to try to curb the virus until there's enough vaccine to go around".

Every country has different rules for determining when an experimental vaccine is safe and effective enough to use.

Intense political pressure to be the first to roll out a rigorously scientifically tested shot colored the race in the US and Britain, even as researchers pledged to cut no corners. In contrast, China and Russia have offered different vaccinations to their citizens ahead of late-stage testing.

The shots made by US-based Pfizer and its German partner BioNTech were tested in tens of thousands of people.

And while that study isn't complete, early results suggest the vaccine is 95 per cent effective at preventing mild to severe Covid-19 disease.

The companies told regulators that of the first 170 infections detected in study volunteers, only eight were among people who had received the actual vaccine and the rest had gotten a dummy shot.

"This is an extraordinarily strong protection," Dr Ugur Sahin, BioNTech's CEO, recently told The Associated Press.

The companies also reported no serious side effects, although vaccine recipients may experience temporary pain and flu-like reactions immediately after injections.

But experts caution that a vaccine cleared for emergency use is still experimental and the final testing must be completed.

Still to be determined is whether the Pfizer-BioNTech shots protect against people spreading the coronavirus without showing symptoms. Another question is how long protection lasts.

The vaccine also has been tested in only a small number of children, none younger than 12, and there is no information on its effects in pregnant women.

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Pfizer and Biontech apply for corona vaccine approval in Norway, EU

 

Pfizer and Biontech have submitted the formal application to have their coronavirus vaccine approved in the EU. Approval would also apply in Norway.

About two weeks ago, Pfizer stated that its coronavirus vaccine is 95% effective against the coronavirus.

The European Medicines Agency (EMA) recently said that the first vaccines could be approved in late 2020 or early 2021.

An approval from the EMA means that the vaccine would also be approved in Norway.

Norway is also a party to the major procurement agreements the EU has entered into for the purchase of several vaccines, including an agreement with Pfizer and Biontech.

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COURTESY NORWAYTODAY

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UK to approve Covid-19 vaccine developed by Pfizer and BioNTech next week

 

The United Kingdom will approve next week the vaccine for Covid-19 developed by Pfizer and BioNTech, and the deliveries will start in a few hours from its authorization, the Financial Times publication quoted by Reuters, taken over by News.ro , reported on Saturday .

The first immunizations with the vaccine created by Pfizer and BioNTech will take place starting December 7, the Financial Times also wrote, citing sources.

Also on Saturday, Prime Minister Boris Johnson appointed Nadhim Zahawi, currently deputy minister of business, as the minister responsible for distributing vaccines for Covid-19.

The United Kingdom announced on November 20 that it had formally requested its medical regulator, the Medicines and Medicines Regulatory Agency (MHRA), to assess the suitability of the Pfizer-BioNTech vaccine for Covid-19 as the first step in its distribution. outside the United States.

The UK has ordered 40 million doses of the vaccine, which has been shown to be 95% effective in preventing the spread of the virus, which has killed more than 1.4 million people worldwide and devastated the global economy.

The government on Friday asked the regulator to evaluate AstraZeneca's Covid-19 vaccine for possible authorization.

The London executive has contracted 100 million doses of the vaccine developed by AstraZeneca and Oxford University and aimed to have it distributed soon in the days to come.

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COURTESY universul.net

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Hyderabad emerging as new Covid-19 hotspot as case positivity, deaths rise

 

Hyderabad — Sindh's second-largest city after Karachi — is fast emerging as a coronavirus hotspot, with a rise in both the city's positivity ratio and mortality rate worrying doctors.

As Hyderabad's health care workers brace for the second wave of Covid-19, three patients lost their lives from the virus in the past day at Liaquat University Hospital's (LUH) City branch.

“Three deaths are reported in our high dependency unit (HDU) and intensive care unit (ICU),” said Dr Aftab Phull, focal person for LUH Hyderabad. The deceased included two men aged 71 years and 58 years, respectively, and a 70-year-old woman.

Hyderabad reported its first Covid-19 case on March 10, a woman who had arrived from Iran after pilgrimage. The city's positivity rate declined in the July-August period but from then onwards, a rise in cases was seen in laboratory reports.

The National Command and Operation Centre had last week reported that Hyderabad had the highest positivity ratio of Covid-19 cases in Pakistan at 16.59 per cent. However, Sindh government spokesperson Murtaza Wahab at the time contradicted the figure, saying the positivity rate in the Hyderabad district stood at 8.7pc.

According to Prof Dr Ikram Ujjan, head of the Diagnostic and Research Laboratory (DRL) of the Liaquat University of Medical and Health Sciences (LUMHS), Hyderabad's positivity ratio in late October and early November had varied between 10pc and 12pc.

“And now cases are increasing,” he said, adding that the positivity rate was increasing in districts of Sindh other than Karachi and Hyderabad as well. “These districts in lower and upper Sindh were [earlier] reporting around 1pc positivity ratio but it is now climbing up to 4pc which is a sharp increase.”

According to reports of tests conducted at the DRL, 293 samples were tested during the last 24 hours of which 42 returned positive — a positivity rate of 14pc.

The rate is based on tests conducted only at the government facility, and does not include tests conducted at private labs.

In June, 'smart' lockdowns were imposed in 70 areas of the city by the district administration with the Sindh government’s approval, leading to a drop in the positivity ratio from 38pc to 2pc in August, according to daily situation reports issued by the provincial government.

“The situation is worrying us. The second wave seems to be more severe. We need to go for intermittent lockdown,” said Prof Dr Imran Ali Shaikh of LUMHS. “The situation had changed when the lockdown was imposed. We can perhaps keep businesses closed on Friday and Sunday. It will help reduce the ratio of the infection’s transmission among people.”

According to him, the positivity ratio of Hyderabad was 2.4pc to 2.5pc during the first wave in March-April. “Now it is clearly 12pc to 13pc and it is dangerous,” he added.

Despite the increasing numbers, Dr Shaikh said the general public appeared unfazed.

“People don’t care what we advise them as they don’t follow standard operating procedures or observe social distancing,” he said. He strongly advised for immediately shifting Covid-19 patients to hospitals or to quarantine them in homes.

Dr Shaikh also pointed out another worrying factor, concerning unconfirmed reports of different laboratories. “We are getting reports in which patients have clear symptoms of novel coronavirus but on the basis of some private laboratories' reports, those patients are being treated for typhoid and not Covid-19,” he said, urging the government to look into the matter. “I am getting patients at my clinic with clear symptoms of coronavirus and there are several other doctors who are receiving such patient.”

As per the district health office (DHO) figures, there are 1,355 active coronavirus cases in Hyderabad. And out of these, 1,332 patients are in home isolation. Since the outbreak hit Hyderabad, a total of 6,774 positive cases were reported and of them 5,314 recovered. At least 105 deaths have been reported in the district so far. However, this mortality figure is exclusive of the patients who hailed from other districts of Sindh but were admitted to and died in LUH's City branch.

LUH’s Dr Phull said the hospital currently had 23 Covid-19 patients. Of them 11 are in HDU, nine in ICU and three are under-trial prisoners. “We have 20 beds each in HDU and ICU. Normally not all patients need ICU but positive coronavirus patients’ flow is indeed now increasing,” he remarked.

The district administration has been enforcing timing restrictions on all wedding halls and businesses except for pharmacies and medical stores. Officials have been imposing fines on eateries and owners restaurants if they are seen serving customers after 10pm.

“All businesses are to close by 10pm except for medical stores in Hyderabad," said Fuad Soomro, Hyderabad's deputy commissioner. “We will also ensure implementation of the ban on holding of weddings in marriage halls as per Sindh government’s directives.”

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