Pfizer-BioNTech, Moderna, J&J, AstraZeneca investigating omicron

The world’s largest manufacturers of Covid-19 vaccines announced on Friday that they were working to rapidly screen their vaccines and adapt them to a new and highly mutated strain of the virus.

The World Health Organization said Friday the new strain, dubbed Omicron, is a “worrying variant” that could pose a higher risk of reinfection than previous mutations of the virus.

Pfizer and BioNTech said they are studying Omicron, labeled B.1.1.529 first, and can quickly adjust their vaccine if necessary.

“We understand the concerns of experts and immediately initiated investigations into variant B.1.1.529,” said the company.

Pfizer and BioNTech expect further data from laboratory tests in two weeks at the latest.

“These data will provide more information on whether B.1.1.529 could be an escape variant that could require our vaccine to be modified if the variant spreads globally,” the companies said.

Pfizer and BioNTech said they can customize their mRNA vaccine within six weeks and start shipping within 100 days if an escape variant is identified.

Johnson & Johnson on Friday said they are already testing their vaccine against Omicron.

“We are closely monitoring newly emerging COVID-19 virus strains with variations of the SARS-CoV-2 spike protein and are already testing the effectiveness of our vaccine against the new and rapidly spreading variant, which was first discovered in southern Africa,” said J&J .

AstraZeneca said the variant is also being investigated. Its vaccine platform, developed with Oxford University, enables rapid response to new mutations as they occur, the company said.

“AstraZeneca is also doing research in places where the variant has been identified, namely in Botswana and Eswatini,” the company said.

Modern, said in a statement on Friday that the combination of mutations in the variant “poses a significant potential risk of accelerating the decline in natural and vaccine-induced immunity”.

“A booster dose of an approved vaccine is the only strategy currently available to boost declining immunity,” the company said.

Moderna said it would test three booster candidates against Omicron, also in higher doses. The company will also develop a booster dose specific to the variant.

“We have said from the start that it is imperative that we be proactive in fighting the pandemic as the virus evolves,” said Stephane Bancel, CEO of Moderna, in a statement. “The mutations in the Omicron variant are worrying and for several days we have been working as quickly as possible to implement our strategy to combat this variant.”

The variant that originated in South Africa has around 50 mutations, more than 30 of which are on the spike protein, which enables the virus to bind to human cells. The spread of the new variant is still in its infancy, and it is not yet clear how difficult it would be to infect a vaccinated person.

Several European and Asian nations have suspended flights from southern Africa in response to the variant. The UK suspended flights from six countries in the region on Thursday and the European Commission – the executive body of the European Union – has asked all 27 member states to suspend travel from southern Africa.

White House senior medical advisor Dr. Anthony Fauci said Friday that the US is working with South African scientists to determine the molecular makeup of the variant so that laboratory tests can be carried out. These tests would help determine whether or not the variant can evade the vaccines’ antibody protection.

Fauci said data would help determine whether or not the US should put in place similar travel restrictions. The Biden government later confirmed Friday that the US would restrict entry to non-citizens from eight South African nations.

The strength of Covid vaccines against infection has decreased over time, although they are still highly effective at preventing hospitalizations and deaths. A study published in Science this month found that the Pfizer vaccine’s effectiveness in preventing infections decreased from 86% to 43% from February through October. Moderna’s vaccine decreased from 89% to 58% and J & J’s vaccine decreased from 86% to 13% effectiveness against infections in the same study.

The US Centers for Disease Control and Prevention last Friday approved booster vaccines of Pfizer-BioNTech and Moderna vaccines for all adults. Pfizer’s booster dose was 95% effective in preventing symptomatic infection in people who had no evidence of previous infection in a clinical study of 10,000 subjects 16 years and older, the company said. Moderna is still conducting a clinical study on the effectiveness of its booster dose.

Blood clots linked to AstraZeneca shot have 22% mortality fee: examine

A paramedic prepares doses of the AstraZeneca vaccine for patients at a walk-in COVID-19 clinic at a Buddhist temple in the Smithfield suburb of Sydney on Aug. 4, 2021.

Saeed Khan | AFP | Getty Images

A new study has provided further details on the “rare but devastating” blood clotting complications associated with the Oxford-AstraZeneca Covid-19 vaccine.

In a peer-reviewed article published Wednesday in the New England Journal of Medicine, Massachusetts Medical Society scientists analyzed the first 220 cases of the disease reported in the UK.

The Oxford-AstraZeneca vaccine – now one of the most widely used Covid vaccines in the world – was launched in the UK in January, making it the first country to give the vaccine.

A very small number of people who have been vaccinated with the AstraZeneca Vaccine have suffered blood clots. The condition, described by health authorities marked as “extremely rare” by blood clots accompanied by low platelet counts.

Massachusetts Medical Society study uses data from 294 patients who presented to UK hospitals between March 22nd and June 6th) – have been identified.

All of these patients had received their first dose of the Oxford-AstraZeneca shot and went to hospital with symptoms between 5 and 48 days after their vaccination. The average time between vaccination and hospitalization was 14 days, the results showed.

The overall mortality rate for VITT in the study was 22%.

The researchers also found that 41% of patients who presented with VITT were not diagnosed with any underlying health problems. Of those who reported a past or current illness, the study found that there were no prevalent diseases or medications that were “unexpected in the general population”.

“Against the background of a successful vaccination program in the UK, VITT has emerged as a rare but devastating complication,” the study’s authors said in their report. “We found that it often affects young, otherwise healthy vaccine recipients and is associated with high mortality.”

“In our cohort, 85% of the patients were younger than 60 years, although the (Oxford / AstraZeneca) vaccination was predominant in older adults,” the scientists found.

As a precautionary measure, the UK is offering people under 40 years of age an alternative to the Oxford AstraZeneca vaccine since May.

People diagnosed with VITT were between 18 and 79 years old, with the mean age being 48, the study showed.

As of July 28, inclusive, an estimated 24.8 million first doses of the Oxford-AstraZeneca Covid vaccine had been administered in the UK, with an estimated 23.6 million second doses received.

On July 28, government figures show that for every million first or unknown doses of the Oxford AstraZeneca shot, 14.9 people developed a rare blood clot with low platelet counts. After a second dose of the vaccine, the number dropped to 1.8 cases per million.

The overall death rate for that period was 18%, the government data showed, with 73 deaths. Six of these occurred after the second dose.

Late last month, AstraZeneca published a study that found the VITT rate was 8.1 per million after the first dose of its vaccine, which dropped to 2.3 per million after a second dose.

According to official information, 411 suspected cases of VITT had been reported in Great Britain by July 28.

Benefits vs. Risks

Ann Taylor, AstraZeneca’s chief medical officer, said in March that the prevalence of blood clots in the number of people vaccinated is lower than what would normally be expected in the general population.

Both UK and EU drug regulators have identified possible links between the Oxford AstraZeneca vaccine and rare blood clots.

In April, the company announced it would comply with government requests in the UK and Europe to update its Covid vaccine labels. However, it stressed that WHO had said “a causal relationship is considered plausible but not confirmed”.

The UK Joint Vaccination and Immunization Committee has stated time and time again that for the vast majority of people, the benefits of the Oxford-AstraZeneca vaccine continue to outweigh the risks.

Several health authorities including the WHO, the European Medicines Agency and the International Society for Thrombosis and Hemostasis agree that the benefits of giving the vaccine outweigh the risks.

AstraZeneca Misplaced Cash on Its Covid-19 Vaccine



AZN -1.36%

PLC said the sale of its Covid-19 vaccine, which was initially promised to sell for no profit, failed to keep up with costs, causing a slump in earnings and a warning that vaccine efforts could continue to hurt margins.

The drug giant generated $ 275 million in revenue in the first three months of the year from sales of its Covid-19 vaccine, which was developed in partnership with the University of Oxford. The company shipped 68 million cans worldwide in the first quarter, well below target.

In Europe, tens of millions of cans of AstraZeneca deficits have sparked political tension. This week has the The European Union sued the companyon the charge of not having fulfilled the vaccination contract with the block. AstraZeneca has announced that it will meet the delivery commitments.

Most of AstraZeneca’s vaccine sales for the quarter, $ 224 million, were in Europe, with $ 43 million in sales in emerging markets. The numbers pale in comparison to multi-billion dollar sales projections from other vaccine manufacturers, including

Pfizer Inc.


Modern Inc.

More about the AstraZeneca vaccine

At least for AstraZeneca, vaccine expenses were initially a drag on earnings for an otherwise strong quarter. Stocks rose 3% in early trading due to better-than-expected sales and profits. The cost of vaccination cut earnings per share for the quarter by 3 cents, which was $ 1.18, down from 59 cents for the comparable quarter of 2020.

The company and its manufacturing partners have shipped 300 million doses of vaccine worldwide to date, a year after AstraZeneca agreed to join Oxford’s efforts to cause a pandemic worldwide.

The company said it was costly to provide an “equitable supply” of the vaccine for no profit, which has a significant impact on overall profit margins. Core gross profit margins decreased 3 percentage points to 74.6% for the quarter.

“It is expected that these gross margin fluctuations will continue between quarters,” said AstraZeneca. On a call with reporters, executives said that as supplies continue, fluctuations will stabilize and the company expects to break even over time.

Board chairman Pascal Soriot said that despite disappointments and criticism, AstraZeneca has no regrets about its efforts to get a Covid-19 vaccine or its non-profit approach with Oxford. He pointed up India grappling with rising infections and deathswhere the AstraZeneca vaccine is the dominant shot available.

Dr. Soriot said more than a hundred Covid-19 vaccines were developed in the past year and only a handful made it to market. “Where are all these vaccines? You are nowhere. “He said that despite the major supply shortages in Europe, AstraZeneca will have delivered 50 million cans to the block between February and late April.

The Anglo-Swedish drugmaker said Friday it plans to apply to the U.S. Food and Drug Administration for approval of the vaccine in the coming weeks.

AstraZeneca’s US rollout plans have experienced lengthy delays after initial estimates that the shot could be available in late 2020. The drug maker announced in March this year that it would file for an FDA review by mid-April. The Wall Street Journal reported Thursday that AstraZeneca had advised US officials in recent days that it could need until mid-May to finish the application.

Europe’s leading medicines agency has approved AstraZeneca’s vaccine after it was exposed in several countries over blood clot concerns.

The company has worked hard to bring together the complete data required for the report, including efficacy and safety statistics from nearly four months of vaccinations in the UK, as well as data from large-scale US and UK human studies, The Journal reported.

Total earnings for the first quarter exceeded analysts’ expectations at $ 1.56 billion, roughly double last year, with sales up $ 7.3 billion. A key metric, product sales, rose 15% due to the strong performance of cancer drugs and new products in the company’s pipeline.

Last year, the company doubled its full year earnings and signed a $ 39 billion purchase agreement based in Boston

Alexion Pharmaceuticals Inc.,

a manufacturer of Drugs and therapies for rare diseases. However, public attention has been drawn heavily to the Covid-19 vaccine AstraZeneca, which was launched in January when the first mass vaccination with the shot took place in the UK. It is currently used in more than 100 countries.

The vaccination effort has faced a number of hurdles, from confusing clinical trial results and production delays to questions about the exact effectiveness of the shot and rare blood clotting problems in a small percentage of people after vaccination.

Still, it is a major focus of global hopes to contain the pandemic, especially in developing countries that have less access to more expensive vaccines bought by richer countries. According to AstraZeneca, the company has partnered with the Serum Institute of India to deliver more than 48 million cans to a global funding initiative called Covax, which focuses on delivering shots to less affluent countries.

AstraZeneca reiterated its full year outlook for a low percentage increase in total revenue for teens and an increase in core earnings per share from $ 4.00 to $ 4.75-5.00 in constant currencies. The guidelines do not include any revenue or profit impact from the sale of Covid-19 vaccines or the proposed acquisition of Alexion.

Write to Jenny Strasburg at

Copyright © 2020 Dow Jones & Company, Inc. All rights reserved. 87990cbe856818d5eddac44c7b1cdeb8

EU prepares authorized motion towards AstraZeneca over vaccine supply shortages

President of the EU Commission Ursula von der Leyen

Thierry Monasse | Getty Images News | Getty Images

LONDON – The European Union is preparing legal action AstraZeneca about delivery bottlenecks of his Coronavirus Vaccine, according to four people familiar with the matter.

The EU and the pharmaceutical company were at odds on different occasions this year. Anglo-Swedish company AstraZeneca said it couldn’t deliver as many vaccines as the block expects in both the first and second quarters. This has delayed the rollout of Covid-19 vaccines in the 27 EU countries.

The European Commission, the EU’s executive branch, told the 27 European ambassadors at a meeting on Wednesday that they were considering legal action against AstraZeneca over these delivery issues, four EU officials who said they refused to be named due to the sensitivity of the issue CNBC Thursday. Politico first reported on the Commission’s plan late Wednesday.

“The commission wants to act quickly. It’s a matter of days,” one of the officials told CNBC over the phone, adding that the ambassadors had given “great support” to the legal process.

The same official stated that “few legal issues” were considered before the trial proceeded.

A second official said the Commission is taking this step to ensure that upcoming deliveries are as expected.

When a European Commission spokesman was contacted by CNBC on Thursday, he said: “It is critical that we ensure the delivery of a sufficient number of cans in line with the company’s previous commitments.”

“Together with the member states, we are examining all possibilities to achieve this,” said the same spokesman, without confirming or denying that legal action has been considered.

In March, the President of the European Commission, Ursula von der Leyen, expressed her disappointment with AstraZeneca during a press conference and said: “Unfortunately, AstraZeneca has produced too little and delivered too little. And of course this has painfully slowed the vaccination campaign. “

At the time, von der Leyen said the block was expecting 70 million cans from the company in the second quarter, compared to an originally expected 180 million.

Pascal Soriot, CEO of AstraZeneca, told EU lawmakers in February that low yields in EU production facilities were causing the delays.

A medical worker holds a vial containing the AstraZeneca COVID-19 vaccine at a vaccination center in Ronquieres, Belgium, on April 6, 2021.

Yves Herman | Reuters

Might AstraZeneca Double Your Cash Regardless of Vaccine Woes?

Why would anyone want to invest in a company that keeps making headlines for the wrong reasons? Between manufacturing issues, inconsistencies in clinical trials, repeated hiccups with regulators on both sides of the Atlantic, and a global public call for coronavirus vaccinations AstraZeneca‘s ((NASDAQ: AZN) Reputation is getting worse and the stock is struggling. Additionally, these issues have played back every few months for almost a year, making it a lot easier to incorporate into the narrative of an increasing breakdown.

As monumental as the company’s stumbling blocks may appear, investors need to keep their eyes on them long-term. AstraZeneca’s critical coronavirus vaccine is reaching the public and its reputation will eventually recover. Despite the recent problems, the population could grow earlier than expected. But could it double the investment of someone who just bought it?

Image source: Getty Images.

Vaccine setbacks abound

Let’s start with the bear case first. In my view, the bearish argument against AstraZeneca is that the parade of subjects With its coronavirus vaccine, they point to deeper problems in the way the company works. In particular, the clinical and regulatory processes, which are vital for a drug manufacturing company, appear to be the source of the recent problems.

In November, management claimed that the company’s coronavirus vaccine, co-developed with Oxford University, was 70% effective. However, upon closer inspection of the results, the observers realized that the claim of 70% effectiveness was in fact derived from two separate clinical studies with slightly different parameters.

It was soon discovered that a manufacturing problem had caused some of the doses in the trial to be half what they were intended to be. The doubt on the company’s data summary while manufacturing and clinical operations look less than stellar. At the time, I realized the mishaps had shaken my (previously quite strong) confidence in the stock.

A recent press release from AstraZeneca in the US used older data on the effectiveness of the vaccine than available. This prompted Dr. Anthony Fauci, director of the National Institute of Allergies and Infectious Diseases (NIAID), said earlier this week that the problem with the data “was really what you call an informal error because the fact is that it is very likely to be a mistake is. ” very good vaccine. “

To say that such criticism from any of the leading regulators in a large market could lead investors in the face is a massive understatement. Once again, AstraZeneca communications posed more problems other than there is now enough ammo for naysayers to see a trend from crisis to crisis.

Buckle up for half a decade

As bad as this may seem, it is important to have a long-term view of the company’s assets. Over the past five years, AstraZeneca’s total return on equity has more than doubled. Quarterly sales are currently growing 11.2% year over year, and earnings are growing even faster at 223.3%.

Keep in mind that the coronavirus vaccine is just one high-revenue project among countless others in the company’s portfolio. In addition, dozens of other drugs are currently in development, each of which could catalyze further growth in the inventory as it progresses through clinical trials. Regardless of how successful the vaccine is in trade – and if global demand shows it will be a huge success – shareholders can continue to look forward to moderate growth.

^ SPX chart

^ SPX Data from YCharts

That said, AstraZeneca won’t explode overnight. Market capitalization is simply too high for the stock price to fluctuate widely despite the added boon of new vaccine revenue. However, this shouldn’t deter potential buyers who have a long-term market approach.

Stock price isn’t the only element to consider either. The company forward Dividend yield of 2.82% is a key element in total shareholder return, and the dividend has grown steadily over the past 20 years. If you buy the stock now, it may mean you are getting a discount as the stock price is still dependent on the impact of recent bad news.

Assuming vaccine revenues don’t change dramatically from management’s expectations and no major disasters are imminent (knock on wood), it makes sense that AstraZeneca could double again between now and 2026 or 2027. Don’t wait too long to make a decision, however, once the vaccine rollout is back on track, the stumbling blocks will fade from the market’s minds pretty quickly, and the stock may not be a bargain afterward.

This article represents the opinion of the author who may disagree with the “official” referral position of a Motley Fool Premium Consulting Service. We are colorful! Questioning an investment thesis – including one of our own – helps us all think critically about investing and make decisions that will help us get smarter, happier, and richer.

EU steps up vaccine exports guidelines and pressures AstraZeneca over deliveries

President of the European Commission Ursula von der Leyen.

Thierry Monasse | Getty Images News | Getty Images

LONDON – The European Union has tightened strict regulations on the export of Covid vaccines while putting pressure on it AstraZeneca to deliver more footage to the region.

It is because the sluggish introduction of vaccines in the region is under scrutiny, even as the EU continues to export millions of coronavirus shots abroad.

In order to gain a stronger negotiating position with pharmaceutical companies that fail to meet delivery targets, the bloc has expanded its strict rules on vaccine exports.

Before approving shipments from Covid-19 The EU will examine whether the recipient country has any restrictions on vaccines or raw materials and whether it is in a better epidemiological situation.

“We want to make sure that Europe gets its fair share of vaccines. Because we have to explain to our citizens that companies that export their vaccines around the world are fully committed to their commitments and are not taking any risks.” Security of supply in the European Union, “said the President of the European Commission, Ursula von der Leyen, on Thursday.

We all know we could have been a lot faster if all the pharmaceutical companies had fulfilled their contracts.

Ursula von der Leyen

President of the European Commission

The data released on Thursday showed that the EU has exported 77 million cans of Covid shots to 33 countries around the world since December. At the same time, 88 million were delivered to EU countries, of which 62 million were managed. As such, the EU has exported more shots than it has previously given its citizens.

However, some EU countries have raised concerns about stricter export regulations, with countries like Belgium and the Netherlands wanting supply chains to remain open. There is a risk that stopping vaccine exports will trigger a trade war and other parts of the world – which produce the raw materials needed to make vaccines – stop shipping to Europe.

Pressure on AstraZeneca

The EU has also quarreled with the Swedish-UK drug maker over not firing as many Covid shots as the bloc expected.

The 27 nations waited for 90 million doses of this vaccine in the first quarter and 180 million in the second quarter of 2021. However, AstraZeneca said that due to manufacturing issues, only 30 million doses can be dispensed by the end of March and 70 million between April and June.

The reduced delivery targets are a problem for EU countries, some of which wanted more of this vaccine as it is cheaper and easier to store than others. Further delivery delays to Europe could affect the broader rollout plans.

“We all know we could have been much faster if all pharmaceutical companies had fulfilled their contracts,” said von der Leyen on Thursday.

During a press conference, she added that AstraZeneca “needs to catch up, respect the treaty with European member states, before it can export vaccines again”.

A deal with the UK

The EU’s stricter export regulations could become a problem especially for the UK, which has received vaccines from the EU. The vaccination rate is higher than that of the block based on the number of first doses given.

European Commission figures show the UK has received 21 million doses of vaccine block-made – the highest share of EU exports yet. The UK has so far given its population 31 million doses of Covid-19 syringes, suggesting that around two-thirds of the vaccines used in the UK come from the EU.

“We discussed what else we can do to ensure a mutually beneficial relationship between the UK and the EU on Covid-19,” the two sides said in a joint statement on Wednesday.

“Given our interdependencies, we are working on specific steps that we can take in the short, medium and long term to create a win-win situation and expand the supply of vaccines to all of our citizens.”

Dutch Prime Minister Mark Rutte said at a press conference on Thursday that a vaccine deal between the EU and Great Britain could be announced on Saturday.

AstraZeneca points up to date part three trial knowledge

A healthcare worker prepares to inject a vaccine against AstraZeneca coronavirus disease (COVID-19).

Eloisa Lopez

AstraZeneca released updated Phase 3 trial data for its Covid-19 vaccine on Wednesday after facing accuracy issues related to a preliminary report from its U.S. study earlier this week.

The Company Now it’s said his vaccine is 76% effective in protecting against symptomatic cases of viruses. A publication released on Monday reported a symptomatic efficacy rate of 79%. The updated report claims the shot is 100% effective against serious illness and hospital stays.

A group of US health officials criticized the company over the past few days for claiming that they are collecting data to make the results seem more favorable.

The National Institute for Allergies and Infectious Diseases It was announced on Tuesday that it had been informed The UK-based company may have included information from its US results that provided an “incomplete view of efficacy data”.

AstraZeneca said at the time that the numbers were based on a “pre-determined interim analysis” and promised to share the updated analysis in the coming days.

Dr. Anthony Fauci, Chief Medical Officer and White House Director at NIAID, described the situation as “unfortunate” and said it was likely that AstraZeneca would issue a modified statement.

“This is really what you call an easy mistake as it is most likely a very good vaccine,” Fauci told ABC’s Robin Roberts on Good Morning America Tuesday. “Something like that … really creates doubts about the vaccines and maybe adds to hesitation. It wasn’t necessary.”

The updated results include data from 190 symptomatic cases in more than 32,000 participants – an increase of approximately 50 symptomatic cases studied compared to the Record published on Monday.

The results suggest that the vaccine is more effective than previously thought in patients aged 65 and over, with a newly reported efficacy rate of 85% for this population versus 80% previously reported.

AstraZeneca reiterated Wednesday that the vaccine was “well tolerated” among participants and that no safety concerns were identified.

AstraZeneca has had a separate backlash over the past few weeks Reports of blood clotting associated with the vaccinealready approved and used by dozens of countries around the world. Several European nations have suspended and then resumed use of the vaccine after independent safety reviews.

– CNBC’s Berkeley Lovelace Jr., Sam Meredith, and Steve Kopack contributed to this report.

Analysts cheer ‘surprisingly constructive’ AstraZeneca U.S. trial information

A bottle of the AstraZeneca vaccine.

Igor Petyx | KONTROLAB | LightRocket via Getty Images

Health analysts welcomed AstraZenecaThe results of the much-anticipated late-stage US study results for the Covid-19 vaccine.

The study of more than 30,000 participants in the US, Peru, and Chile found the vaccine to be a Overall effectiveness of 79% in preventing symptomatic Covid and 100% effectiveness in preventing serious illness and hospitalization.

Efficacy was consistent across ages and races, with 80% effectiveness in participants 65 and over. Known as AZD1222 and jointly developed with Oxford University, the vaccine was well tolerated and the independent data security watchdog did not find any security concerns related to the vaccine, the company said Monday.

The data exceeded expectations

In a research note, Jefferies health analyst Peter Welford described the data as “surprisingly positive”.

Adam Barker, Health Analyst at Shore Capital, said, “This is arguably the first study for AZD1222 that has shown convincing efficacy in those 65 years and older.”

This is important as there have been questions about its effectiveness in this age group. Previous studies have been hampered by fewer older participants. In this study, 20% of participants were 65 years of age or older and 60% had comorbidities, which placed them at increased risk of developing serious illnesses.

Monday’s trial data confirmed the vaccine’s safety profile. Barker said that having the data from a single study with a single-dose regimen removes the data interpretation complications seen in the past with the AstraZeneca-Oxford vaccine.

Barker added that the lack of evidence of blood clots in the study was also comforting in light of recent concerns. “We are not surprised by these data, however, as the evidence of a link between the vaccine and the blood clots was already quite weak.”

AstraZeneca said it will continue to analyze the data and prepare for the primary analysis to be submitted to the U.S. Food and Drug Administration for emergency approval in the coming weeks. The vaccine has already received conditional marketing or emergency marketing authorization in more than 70 countries on six continents.

Dosing regimen a key issue for the FDA

“I can’t understand why the regulator wouldn’t approve this,” Barker wrote, but warned that the detailed data is pending.

A key question for the FDA will be what dosage regimen it will endorse should it end up using the vaccine in an emergency.

“This study is based on dosing 4 weeks apart, but we know The effectiveness can be higher if you dose with a longer interval (up to 12 weeks) and countries like the UK have successfully used this “longer period between doses” strategy to vaccinate more people quickly, “Barker said.

So the question for the FDA is whether it will recommend giving the two doses four weeks apart – assuming this was tested in the US study – or including data from the UK and other countries suggesting a longer duration .

Welford also noted the sub-optimal dosing regimen used in this study. “The study evaluated the 4-week dosing schedule, but we have evidence that the vaccine works better with longer dosing intervals,” he said.

“The primary analysis of the UK, Brazil and South Africa Phase III clinical trials found 62% efficacy when the vaccine was given 4 to 12 weeks apart, but efficacy increased to 82% when the interval was 12 weeks has been extended. “”

In addition to the dosage, analysts also observe in detail how the vaccine protects against different variants. This is expected to be included in the data packet that will be submitted to the FDA.

When it comes to comparing today’s efficacy data with that of some other vaccine manufacturers, Welford has been warning since the first vaccine readings from Pfizer and ModernCovid-19 variants have become more and more common, so the effectiveness data for the different vaccines cannot be directly compared.

Barker added that the trial results gave the vaccine important validation. “Because of its cost and ease of storage and distribution, AZD1222 was once dubbed the ‘Vaccine for the World’. We think this is a fair label,” he wrote. “Data like this, reported today to be more conclusive about the effectiveness and safety of AZD1222, is certainly cause for celebration.”

AstraZeneca has committed to distribute the vaccine for the duration of the pandemic for no profit. The company’s shares traded 2% higher in London on Monday.

AstraZeneca vaccine halt may gradual Asia’s financial restoration: Moody’s Analytics

Yangshan Deepwater Container Port in Shanghai, China.

Qilai Shen | Corbis historical | Getty Images

SINGAPORE – Asia’s economic recovery may slow Other countries are suspending use of the Covid-19 vaccine developed by AstraZeneca and the University of Oxford warned Asia Pacific chief economists about Moody’s Analytics.

“It adds a modest risk to Asia’s role in global economic turnaround,” Steve Cochrane told CNBC “Squawk Box Asia” on Tuesday.

Reports of blood clots For some people who received the AstraZeneca-Oxford shot, several countries – many of them in Europe – led them to temporarily stop using the vaccine. The World Health Organization said There is no association between the shot and an increased risk of developing blood clots and is being investigated.

Impact of vaccines on world trade

Cochrane said issues related to the AstraZeneca-Oxford vaccine could affect world trade – and that’s bad news for Asia, where many economies are dependent on trading activities.

The vaccine is of course a risk. One of the critical risks is that vaccines will have to be introduced later this year to get the world economy back on its feet.

Steve Cochrane

Asia Pacific Chief Economist, Moody’s Analytics

“There is a possibility that world trade will be adversely affected if the introduction of vaccines in Europe is delayed. This would result in a more stalled economy in Europe. This could slow the pace of world trade.” ,” he explained.

Asian countries were relatively successful in containing the virusand that has helped their economies recover faster than those in Europe and the US

Fortunately, re-locks in some parts of Europe haven’t affected manufacturing, Cochrane said. He added that “almost all” of the effects of these lockdowns have affected the service sector.

“So right now it’s not that big of a problem, and world trade still seems very, very strong,” said the economist. “The vaccine is, of course, a risk. It is one of the critical risks. We have yet to see how vaccines are introduced later this year to get the world economy back on its feet.”

Thailand briefly stops the AstraZeneca vaccine

Thailand temporarily stopped using the AstraZeneca-Oxford vaccine on Friday, but authorities said Monday they would continue to administer the shots.

Thai Prime Minister Prayuth Chan-ocha became the first person in the country to get the AstraZeneca-Oxford shot on Tuesday, Reuters reported.

In other Asian countries, Indonesia announced on Monday that it was delaying the launch of the AstraZeneca-Oxford vaccine while awaiting review by the WHO. The news agency reported.

– CNBC’s Sam Meredith contributed to this report.

Germany suspends AstraZeneca vaccine amid blood clot fears

LONDON – Germany, France, Spain, Italy, Ireland and the Netherlands have joined growing list of countries who have suspended the use of Coronavirus Vaccine developed by AstraZeneca and Oxford University for blood clot problems.

The Dutch government said on Sunday that the Oxford-AstraZeneca vaccine would not be used until March 29, while Ireland said earlier in the day it had temporarily suspended the shot as a precautionary measure.

On Monday, the federal government also announced that it would stop using it. The vaccine authority, the Paul Ehrlich Institute, requested further investigations. The Italian Medicines Agency made a similar announcement on Monday afternoon, and French President Emmanuel Macron also said that use of the vaccine would be suspended pending a ruling by the EU regulator. Spanish Health Minister Carolina Darias said Monday the country would stop using the shot for at least two weeks, Reuters reported, and Portugal later suspended the vaccine as well.

The World Health Organization tried to downplay the ongoing safety concerns and stated last week that there was no link between the shot and an increased risk of developing blood clots. The United Nations Health Department has urged nations to continue using the Oxford-AstraZeneca vaccine.

Even so, some European countries have already stopped the use of the Oxford AstraZeneca vaccine. It added to the region’s worries sick vaccination campaign at a time when the German health department warned that a third wave of coronavirus infections has already started.

Thailand has also stopped the planned use of the vaccine.

The move to discontinue use by Dutch and Irish officials came shortly after the Norwegian Medicines Agency said Three health workers were reported to have been treated for bleeding, blood clots and low platelet counts in the hospital after receiving the Oxford AstraZeneca vaccine. Norway has suspended its vaccination program against Oxford-AstraZeneca.

Geir Bukholm, director of the Infection Control and Environmental Health Department at the Norwegian Public Health Institute, said the Norwegian Medicines Agency will “follow up on these suspected side effects and take the necessary action in this serious situation”.

The picture taken on November 27, 2020 shows “Nikki” Anniken Hars treating a Covid-19 patient in the intensive care unit of Oslo University Hospital Rikshospitalet in Oslo, Norway.

JIL YNGLAND | AFP | Getty Images

The European Medicines Agency, the European Medicines Agency, said there was no evidence that Oxford-AstraZeneca’s vaccine caused blood clots and believed that the vaccine’s benefits “continue to outweigh the risks”.

The EMA admitted that some European countries had stopped using the Oxford-AstraZeneca shot, but said vaccinations may continue to be given while a clot investigation is ongoing.

Irish Prime Minister Micheal Martin told CNBC on Monday that he anticipated a temporary hiatus and that the country wanted to catch up with its vaccination program quickly.

“No causal effect or anything like that has been identified yet, but as a precautionary measure, in line with the precautionary principle and with great caution, our clinical advice has been to halt the program while the EMA reviews,” he said. “This is an undesirable pause, but I still think it’s important that we heed the advice we received.”

How did AstraZeneca react?

“A careful review of all available safety data on more than 17 million people vaccinated with the AstraZeneca COVID-19 vaccine in the European Union (EU) and the UK found no evidence of an increased risk of pulmonary embolism, deep vein thrombosis ( DVT) or thrombocytopenia in a specific age group, sex, specific batch or in a specific country “AstraZeneca said in a statement Sunday.

The most common side effects of the Oxford AstraZeneca vaccine, which does not contain the virus and cannot cause Covid, are usually mild or moderate and improve within a few days after vaccination.

A health worker holds a box of the AstraZeneneca vaccine at the Bamrasnaradura Institute for Infectious Diseases in Nonthaburi Province on the outskirts of Bangkok.

Chaiwat subprasome | SOPA pictures | LightRocket via Getty Images

The pharmaceutical company said that 15 events involving deep vein thrombosis and 22 events involving pulmonary embolism were reported among those vaccinated in the EU and the United Kingdom.

“This is much less than expected to occur naturally in a general population of this size, and it is similar to other approved COVID-19 vaccines,” said AstraZeneca.

What do the experts say?

“Covid definitely causes bleeding disorders and each of the vaccines prevents Covid disease, including more severe cases,” said Stephen Evans, professor of pharmacoepidemiology at the London School of Hygiene & Tropical Medicine.

“Therefore, it is highly likely that the vaccine’s benefits will significantly outweigh the risk of clotting disorders, and the vaccine will prevent other consequences of Covid, including deaths from other causes.”

Evans said it was “perfectly reasonable” to conduct studies on vaccines and coagulation disorders, but added, “It seems a step too far to take precautionary measures that would prevent people from receiving vaccines that prevent disease.”

Many high-income countries – such as the UK, France, Australia and Canada – have decided to continue rolling out the Oxford-AstraZeneca vaccine.

“When there is clear evidence of serious or life-threatening side effects that have important consequences,” Adam Finn, professor of pediatrics at Bristol University, said in a statement.

“So far, however, this has not been the case, and it is highly undesirable to disrupt a complex and urgent program every time people, after receiving a vaccine, develop illnesses that are random and not causal. In situations like this, it is not easy to Making the right call, but a steady hand on the tiller is probably what is needed most, “said Finn.