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pfizer

Moderna’s Covid Jab Gets EU Approval For Kids Aged 6-11

by Medically Speaking Team February 25, 2022

Moderna’s anti-Covid vaccination was authorised by the European Union’s medicines authority on Thursday for children aged six to eleven, making it the second vaccine to be licenced for younger children in the 27-member bloc.

“The EMA’s human medicines committee (CHMP) has recommended granting an extension of indication for the Covid-19 vaccine Spikevax to include use in children aged 6 to 11,” the Amsterdam-based European Medicines Agency said in a statement.

The jab, developed by US-based pharmaceutical company Moderna, has already been approved for adults and children aged 12 and above.

“As in the older age group, the vaccine is given as two injections in the muscles of the upper arm, four weeks apart,” the EMA said.

Pfizer/BioNTech’s anti-Covid shot called Comirnaty was greenlit for children aged five to 11 in November.

The regulator has so far approved five vaccines for use in the EU: Pfizer and Moderna, which use messenger RNA technology, AstraZeneca and Johnson & Johnson, which use viral vector technology, and Novavax, which is based on a spike protein produced in a laboratory.

February 25, 2022 0 comment

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Pfizer and BioNTech Omicron vaccine delayed: BioNTech CEO

by Medically Speaking Team February 17, 2022

written by Medically Speaking Team

The delivery of Pfizer’s (PFE.N) and BioNTech SE’s vaccine to combat the Omicron COVID-19 variant has been delayed by several weeks due to a slower-than-expected data collection process, according to BionTech Chief Executive Ugur Sahin on Thursday in Germany’s Bild.

Once the vaccine is ready, the company would assess whether it was still needed, Sahin said.

“If the wave ends, that does not mean it can’t begin again,” he told Bild in a video interview, adding that BioNTech was in a position to continue creating new vaccines as variants emerged if needed.

“I really don’t see the situation as dramatic anymore,” he said, referring to how the coronavirus would develop in future.

BioNTech had previously expected to launch the vaccine by end of March, but said in late January that this depended on how much clinical data regulators would require.

Source: Reuters

February 17, 2022 0 comment

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Three doses of Pfizer Covid vaccine better than two shots, Study says

by Medically Speaking Team February 16, 2022

written by Medically Speaking Team

A study indicated that a third dose of the Pfizer COVID-19 vaccination was more effective than two doses of the preventative after one month in preventing infection and hospitalisation. The study, which was published in The Lancet Regional Health-Americas, looked at how successful two doses of the Pfizer COVID-19 vaccine were at preventing infection, hospitalisation, and death for up to eight months after vaccination.

The effectiveness of three vaccine doses was also evaluated up to three months following vaccination, according to the researchers.

From December 2020 to December 2021, the study looked at the electronic health records of 3.1 million Kaiser Permanente members in Southern California.

February 16, 2022 0 comment

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Pfizer asks FDA to allow Covid-19 vaccine for children under 5

by Medically Speaking Team February 2, 2022

written by Medically Speaking Team

Pfizer asked the US on Wednesday to approve extra-low doses of its COVID-19 vaccine for children under the age of five, potentially paving the way for vaccinations to begin as early as March.

The Food and Drug Administration had asked Pfizer and its partner BioNTech to submit their applications earlier than expected in an unusual step.

The country’s 19 million youngsters under the age of five are the only ones who have not yet been vaccinated against the coronavirus. Many parents have advocated for expanding vaccinations to toddlers and preschoolers, particularly since the omicron wave sent a record number of children to the hospital.

If the FDA agrees, Pfizer shots containing just one-tenth of the dose given to adults could be dispensed to children as young as 6 months. Pfizer said Wednesday it had started submitting its data to the FDA and expects to complete the process in a few days.

An open question is how many shots those youngsters will need. Pfizer is testing three shots after two of the extra-low doses turned out to be strong enough for babies but not for preschoolers, and the final data from the study isn’t expected until late March.

That means the FDA may consider whether to authorize two shots for now, with potentially a third shot being cleared later if the study supports it.

The FDA said Tuesday it will convene a panel of independent researchers and physicians in mid-February to help review the Pfizer data. The agency isn’t required to follow the panelists’ advice but their input is a key step in publicly vetting vaccine safety and effectiveness.

The FDA’s ultimate decision could come within the month but that isn’t the only hurdle. The Centers for Disease Control and Prevention also has to sign off.

The Biden administration has been trying to speed the authorization of COVID-19 shots for children, contending vaccinations are critical for opening schools and day care centers and keeping them open, and for freeing up parents from child care duties so they can go back to work.

Yet vaccination rates have been lower among children than in other age groups. As of last week, just 20 per cent of kids ages 5 to 11 and just over half of 12- to 17-year-olds were fully vaccinated, according to the American Academy of Pediatrics. Nearly three-quarters of adults are fully vaccinated.

While young children are far less likely than adults to get severely ill from the coronavirus, it can happen, and pediatric COVID-19 infections are higher than at any other point in the pandemic.

What we’re seeing right now is still a lot of hospitalizations and unfortunately some deaths in this age group, said DrS ean O’Leary of the University of Colorado, who is on the AAP’s infectious disease committee. If the FDA clears vaccinations for these youngsters, that’s going to be really important because all of those hospitalizations and deaths essentially are preventable.

For kids under 5, Pfizer’s study is giving participants two shots three weeks apart, followed by a third dose at least two months later. The company is testing whether the youngsters produce antibody levels similar to those known to protect teens and young adults.

In December, Pfizer announced that children under 2 looked to be protected but that the antibody response was too low in 2- to 4-year-olds. It’s not clear why, but one possibility is that the extra-low dose was a little too low for the preschoolers.

Since the preliminary results showed the shots were safe, Pfizer added a third dose to the testing in hopes of improving protection.

Given how well boosters are working for older age groups, it makes some sense that younger children could benefit from a third shot, O’Leary said.

I certainly can understand where both the company and the FDA are coming from in terms of wanting to move this along, anticipating that there’s going to be a third dose down the line.

February 2, 2022 0 comment

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Pfizer-BioNTech start trial of vaccines for Omicron

by Medically Speaking Team January 26, 2022

written by Medically Speaking Team

The Omicron type of the coronavirus has caused a worldwide outbreak of Covid-19 infection. The substantially modified strain is thought to circumvent current immunizations and infect the host more effectively.

Despite the fact that Omicron has proven to be the most probable variety to cause illness in persons who have been vaccinated, it is unclear if a vaccine adjustment is truly necessary.

Original immunizations continue to provide effective protection against serious disease and death. Studies also suggest that getting a regular booster reduces your chances of preventing even a minor illness.

“We recognize the need to be prepared in the event this protection wanes over time and to potentially help address Omicron and new variants in the future,” Pfizer vaccine research chief Kathrin Jansen said in a statement.

“We recognize the need to be prepared in the event this protection wanes over time and to potentially help address Omicron and new variants in the future,” she said.

Ugur Sahin, CEO of the biotech company BioNTech said protection of the original vaccine did appear to wane more rapidly against Omicron.

“The study is part of our scientific approach to develop a variant-based vaccine that provides protection from Omicron similar to what we have observed with previous variants, but at the same time lasts longer,” Sahin said.

The trial will involve 1,420 people aged 18-55 across the United States and South Africa, with the first participant dosed in North Carolina.

A government panel in Japan approved expansion of Covid restrictions in 18 additional regions, such as the western prefectures of Osaka and Kyoto. The decision was taken due to a rise in cases and hospitalizations, driven by the Omicron variant. Under the new rules, which will last till February 20, regional governors will have the power to ask restaurants to shorten working hours and stop serving alcohol.

January 26, 2022 0 comment

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Sputnik V shows higher Omicron-antibody levels than Pfizer in Prelim study

by Medically Speaking Team January 21, 2022

written by Medically Speaking Team

A modest early laboratory investigation found that patients who received Russia’s Sputnik V vaccine had lower levels of Omicron-neutralizing antibodies than those who received Pfizer doses.

The joint Russian-Italian study – funded by the Russian Direct Investment Fund, which markets Sputnik V abroad – compared the blood serum of people who had received the different vaccines.

The preliminary study was conducted by scientists from the Spallanzani Institute in Italy and Gamaleya Institute in Moscow, the developer of Sputnik V vaccine.

Researchers said samples taken three to six months after the second dose of a vaccine have shown that the levels of antibodies in recipients of two doses of Sputnik V were more resistant to Omicron than in those vaccinated with Pfizer.

It included 51 people vaccinated with Sputnik V and 17 after two shots of the Pfizer vaccine.

“Today the necessity of third booster vaccination is obvious,” the preliminary study published on Jan. 19 said.

January 21, 2022 0 comment

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Covid vaccines offer limited protection, ‘if any’: Pfizer CEO

by Medically Speaking Team January 11, 2022

written by Medically Speaking Team

Pfizer CEO Albert Bourla claimed in an interview with CNBC that two doses of the vaccine provide minimal protection, if any, but three doses plus a booster provide reasonable protection against hospitalisation and mortality but less protection against infection. Bourla told CNBC confidentially that the vaccine against the Omicron version will be ready in March.

“I don’t know if we will need it. I don’t know if and how it will be used.” he said. “While the existing system of two vaccine shots and a booster has provided “reasonable” protection against Omicron, a vaccine focused directly on the Omicron variant would also guard against breakthrough infections of a strain that has proven highly contagious and has triggered many mild or asymptomatic cases”, CNBC quoted Bourla as saying.

It’s worth noting that Bourla once stated that two doses of the mRNA vaccine were 100 percent effective in preventing the illness. Bourla sought to rewrite the entire COVID narrative in a series of interviews, while also casting serious doubt on the efficiency of his current product line.

Dr. Bourla, recently told the BBC that getting vaccinated every year might provide a “very high degree of protection” against the fatal disease, which has claimed the lives of up to five million people worldwide.

According to Bourla, omicron is a more challenging target than prior variations. Omicron, which contains hundreds of mutations, is able to circumvent part of the protection offered by Pfizer’s original two doses.

According to statistics from the United Kingdom’s Health Security Agency, two vaccine doses are 52 percent effective at avoiding hospitalisation 25 weeks after having the second jab. The two doses of Pfizer or Moderna vaccines are only approximately 10% effective at preventing omicron infection 20 weeks after the second dose.

The overall efficacy against severe Covid is 80% with two doses of Covishield and 69% with two doses of Covaxin, which is much greater than the efficacy of Pfizer or Moderna. Because Covaxin is a ‘whole virion inactivated coronavirus,’ experts believe it might be extremely effective against the Omicron form (SARS-CoV-2). However, we will have to wait a little longer for real proof to back this up.

Several global health organizations consider the profits made by Pfizer, BioNTech, and Moderna from the epidemic to be unethical. Pfizer is expected to make at least $35 billion in Covid vaccine sales in 2021 and its stock price has risen as a result. Dr. Bourla has made no apologies about profiting, stating that “the bottom line is millions of lives were saved.”. “We have saved the world economy trillions of dollars,” he stated. It provides a tremendous incentive for innovation in the event of the next epidemic, “However, people will realise that there is a financial benefit if they stand up to the challenge and provide something that saves lives and saves money.”

January 11, 2022 0 comment

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Pfizer’s tablet against Covid can be harmful, when taken with other medications

by Medically Speaking December 27, 2021

written by Medically Speaking

Experts have stated that antiviral medicines used to treat Covid may not be safe for everyone. According to NBC, physicians and pharmacists examined the tablets extensively and found that they can be life-threatening when combined with other prescriptions.

The Food and Drug Administration (FDA) recently granted the green light to two pills: Paxlovid by Pfizer and Molnupiravair by Merck.

It has been authorised for mild to moderate Covid in people as young as 12 years, who have underlying conditions that increase the risk of hospitalisation and death from the coronavirus.

The Paxlovid cocktail consists of two tablets of the antiviral nirmatrelvir and one tablet of ritonavir. However, FDA does not recommend Paxlovid for people with severe kidney and liver disease. This is because one of the two drugs in the antiviral cocktail could lead to severe consequences with widely used medications. These medications range from statins, blood thinners to several antidepressants.

In a report by The Hill, a spokesperson said, “The potential for drug-drug interactions (DDI) for Paxlovid was examined in a series of in vitro studies, as well as clinical DDI studies.”

He further added, “The product’s emergency use authorisation fact sheets include information on drug interactions and contraindications. Healthcare providers should consider the potential for drug interactions prior to and during Paxlovid therapy and review concomitant medications during Paxlovid therapy.”

In the case of Merck’s Molnupiravair, the FDA has already restricted its use to adults, only in scenarios in which other authorised treatments, including monoclonal antibodies, are not “clinically appropriate.”

Emily Zadvorny, a clinical pharmacist who is the executive director of the Colorado Pharmacists Society, in a statement to NBC, said, “Pharmacists are highly trained experts in medication safety and monitoring and are an excellent source of information and advice about interactions between medications and also supplements and herbal products. They will help determine if a significant interaction exists and devise solutions to mitigate the interaction if possible.”

Pfizer’s treatment has previously been authorised in the European Union. The US has already paid for 10 million courses.

The authorisation comes as cases are surging across the US, driven by Omicron, the most infectious variant seen so far.

Paxlovid’s therapy consists of a five-day course of two tablets.

December 27, 2021 0 comment

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Omicron can evade immunity provided by Covid vaccines, study suggests

by Medically Speaking Team December 24, 2021

written by Medically Speaking Team

According to a peer-reviewed study, Omicron can circumvent the immunological protection provided by COVID-19 vaccines as well as natural infection, implying that the new coronavirus variation is totally resistant to current antibody therapy.

The study, published in the journal Nature on Thursday, also highlights the need for new vaccines and treatments that anticipate how the SARS-CoV-2 virus may soon evolve.

The researchers from Columbia University in the US and the University of Hong Kong noted that a striking feature of Omicron is the alarming number of changes in the variant’s spike protein that could pose a threat to the effectiveness of current vaccines and therapeutic antibodies.

The study tested the ability of antibodies generated by vaccination to neutralise Omicron in laboratory tests that pitted antibodies against live viruses and against pseudoviruses constructed in the lab to mimic the variant.

The researchers found that the antibodies from people double-vaccinated with Moderna, Pfizer, AstraZeneca, and Johnson & Johnson COVID-19 vaccines were significantly less effective at neutralising Omicron compared to the original virus.

Antibodies from previously infected individuals were even less likely to neutralise Omicron, they said.

People who received a booster shot of either Pfizer or Moderna vaccines are likely to be better protected, although even their antibodies exhibited diminished neutralising activity against Omicron, the study shows.

“The new results suggest that previously infected individuals and fully vaccinated individuals are at risk for infection with the Omicron variant,” said David Ho, a professor at Columbia University Vagelos College of Physicians and Surgeons.

“Even a third booster shot may not adequately protect against Omicron infection, but of course it is advisable to get one, as you will still benefit from some immunity,” Ho added.

The researchers noted that the findings are consistent with other neutralisation studies, as well as early epidemiological data from South Africa and the UK, which show efficacy of two doses of the vaccines against symptomatic disease is significantly reduced against Omicron.

The study also suggests that all of the monoclonal antibody therapies currently in use and most in development are much less effective against Omicron.

Monoclonal antibodies are laboratory-made proteins that mimic the immune system’s ability to fight off harmful pathogens such as viruses.

In neutralisation studies with monoclonal antibodies, only one — Brii198 approved in China — maintained notable activity against Omicron, according to the researchers.

A minor form of Omicron is completely resistant to all antibodies in clinical use today, they said.

The study authors note that Omicron is now the most complete “escapee” from neutralisation that scientists have seen.

They also identified four new mutations in the spike protein of Omicron that help the virus evade antibodies, a finding that could inform the design of new approaches to combat the variant.

The SARS-CoV-2 virus uses the spike protein to enter and infect the human cells.

The researchers suggest that new vaccines and treatments need to be developed that can better anticipate how the virus is evolving.

“It is not too far-fetched to think that SARS-CoV-2 is now only a mutation or two away from being completely resistant to current antibodies, either the monoclonal antibodies used as therapies or the antibodies generated by vaccination or infection with previous variants,” Ho added.

(Content of this post has been auto-generated from a syndicate feed with some changes to the text and headline)

December 24, 2021 0 comment

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Pfizer Covid vaccine provides 70% protection against hospitalization from Omicron

by Medically Speaking Team December 14, 2021

written by Medically Speaking Team

According to a large-scale analysis presented Tuesday in South Africa, a two-dose Pfizer/BioNTech immunisation gives just 33% protection against infection by the omicron version of the coronavirus, but 70% protection against hospitalisation.

The first large-scale analysis of vaccine effectiveness in the region where the new variant was discovered appears to support early indications that omicron is more easily transmissible and that the Pfizer shot isn’t as effective in protecting against infection as it was against the delta variant.

The analysis was based on more than 211,000 positive COVID-19 test results, 41 per cent from adults who had received two doses of the Pfizer vaccine. About 78,000 of these positive COVID-19 test results between Nov. 15 and Dec. 7 were attributed to omicron infections.

The study was carried out by Discovery Health, South Africa’s largest private health insurer, and the South African Medical Research Council.

The study has been carried out in the weeks since omicron was first announced in November by scientists in South Africa and Botswana. The researchers emphasized that its findings are preliminary and not peer reviewed.

The data are gathered from the first three weeks of South Africa’s omicron-driven wave and may change as time passes. South Africa is the first country to experience a surge in COVID-19 driven by the omicron variant.

South Africa has experienced rapid community spread — concentrated in its most populous province, Gauteng — dominated by the omicron variant.

The seven-day rolling average of daily new cases in South Africa has risen over the past two weeks from 8.07 new cases per 100,000 people on Nov. 29 to 34.37 new cases per 100,000 people on Dec. 13, according to Johns Hopkins University. The death rate hasn’t increased during that same period.

“Superb genetic surveillance by the Network for Genomic Surveillance in South Africa identified that omicron infection accounts for over 90% of new infections in South Africa, and has displaced the formerly dominant delta variant,” Discovery Health chief executive Dr. Ryan Noach said.

“The omicron-driven fourth wave has a significantly steeper trajectory of new infections relative to prior waves. National data show an exponential increase in both new infections and test positivity rates during the first three weeks of this wave, indicating a highly transmissible variant with rapid community spread of infection,” Noach said.

The result shows that vaccinated individuals who received two doses of the Pfizer vaccine have 33 per cent protection against infection from omicron, relative to those who were unvaccinated in the first weeks of South Africa’s current omicron-driven wave.

This represents a significant drop from the 80 per cent protection against infection afforded during the earlier period, probably on the basis of lower antibody susceptibility, following the extensive spike protein mutations in the omicron variant.

Encouragingly though, the result shows that these same vaccinated individuals who received two doses of the Pfizer vaccine have 70 per cent protection against hospital admission in this same time period. This protection against hospital admission is reduced from the highs of 93 per cent in South Africa’s delta-driven variant.

The study shows that the protection against hospital admission is maintained across all ages, in people from 18 to 79 years old, with slightly lower levels of protection for older people, with 67 per cent in people age 60 to 69 and 60 per cent for people age 70 to 79. Protection against admission is also consistent across a range of chronic illnesses including diabetes, hypertension, hypercholesterolemia, and other cardiovascular diseases.

The study also found:

1. Omicron poses a higher risk of reinfection. For individuals who have previously had COVID-19, the risk of reinfection with omicron is significantly higher than that of earlier variants.

2. Risk of hospitalisation from omicron is lower. Hospital admissions among adults diagnosed with COVID-19 attributed to omicron is 29 per cent lower compared to the COVID-19 wave that South Africa experienced in mid-2020, after adjusting for vaccination status.

December 14, 2021 0 comment

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