Tag Archives: AstraZeneca vaccine

Meat-free diet may lower severe disease risk; no serious problems found with AstraZeneca shot in Scotland

By Nancy Lapid

(Reuters) – The following is a roundup of some of the latest scientific studies on the novel coronavirus and efforts to find treatments and vaccines for COVID-19, the illness caused by the virus.

COVID-19 severity linked with diet

People on meat-free diets had lower odds of contracting moderate to severe COVID-19, according to a six-country study published on Monday in BMJ Nutrition, Prevention & Health. Plant-based diets were tied to a 73% lower risk of severe disease, researchers found in a survey of 2,884 healthcare providers who cared for COVID-19 patients. Combining those on a plant-based diet and people who also ate fish but no meat, researchers found 59% lower odds of severe disease. The study cannot prove that specific diets protected against severe COVID-19, and diet did not appear to lower the risk of becoming infected. But plant-based diets are rich in nutrients, vitamins and minerals that are important for healthy immune systems, the researchers noted, and fish provide vitamin D and omega-3 fatty acids, which have anti-inflammatory properties. Healthy eating, however, has been problematic during the pandemic, according to two presentations this week during a virtual meeting of the American Society for Nutrition. Consumption of healthy foods such as vegetables and whole grains declined, according to researchers who compared the diets of more than 2,000 Americans before and during the pandemic. In a separate study, researchers who collected dietary data in June 2020 for 3,916 U.S. adults found many had increased their consumption of unhealthy snacks, desserts and sugary drinks during the pandemic. “Individuals may need help to avoid making these dietary changes permanent,” said Dr. Sohyun Park of the U.S. Centers for Disease Control and Prevention, coauthor of the latter study.

No serious problems with AstraZeneca vaccine in Scotland

A study of side effects from AstraZeneca’s COVID-19 vaccine in Scotland found only an association with a largely harmless bleeding condition and no link to the potentially deadly venous clotting in the brain, known as CVST, which has caused concern in Europe and led to pauses in its use. Researchers who tracked 5.4 million people in Scotland found roughly one additional case of idiopathic thrombocytopenic purpura (ITP) per 100,000 people after the first AstraZeneca shot. ITP is a treatable condition of low platelet count and has not caused any deaths among the 1.7 million recipients of the vaccine in the study, the authors reported on Wednesday in Nature Medicine. Due to the rarity of CVST, the Scottish study may have been too small to allow for any conclusions, coauthor Aziz Sheikh of the University of Edinburgh told a media briefing. “The overall message is just the rarity of these outcomes,” said Sheikh. “This is reassuring data.”

Aspirin does not help hospitalized COVID-19 patients

Aspirin did not improve survival or reduce disease severity in a study of nearly 15,000 patients hospitalized with COVID-19. Researchers had hoped that because aspirin helps reduce blood clots in other diseases, it might be helpful in COVID-19 patients who are at a higher risk for clotting issues. Patients randomly assigned to receive 150 milligrams of aspirin once a day did have fewer blood clots, but no lower risk of becoming sicker and requiring mechanical ventilation or better odds of being alive after 28 days. And they had a higher risk of major bleeding complications, a not uncommon issue with aspirin therapy. They did have slightly better odds of getting out of the hospital alive, researchers reported on medRxiv on Tuesday ahead of peer review. But “this does not seem to be sufficient to justify its widespread use for patients hospitalized with COVID-19,” said Peter Horby of the University of Oxford, co-chief investigator of the trial.

COVID-19 control policies still needed in warm weather

In the absence of lockdowns and social distancing, weather and crowding have the biggest impact on COVID-19 spread, a new study found. But even if virus transmission tends to be somewhat lower in warmer conditions, summer weather “cannot be considered a substitute for mitigation policies,” because population density matters more than temperature, according to the report from Imperial College London published on Wednesday in PNAS. Warmer regions should not expect to ease mobility restrictions before colder regions, especially because “warmer regions tend to have higher population densities – for example, the population in Florida is more densely packed than in Minnesota,” coauthor Will Pearse said in a statement. Lockdowns have stronger effects than either temperature or population density, his team reported. Because temperature changes have a much smaller effect on transmission than policy interventions, “while people remain unvaccinated, governments mustn’t drop policies like lockdowns and social distancing just because a seasonal change means the weather is warming up,” said coauthor Dr. Tom Smith. The study also suggests “that lower autumn and winter temperatures may lead to the virus spreading more easily in the absence of policy interventions or behavioral changes.”

(Reporting by Nancy Lapid, Megan Brooks, Ludwig Burger, and Vishwadha Chander; Editing by Bill Berkrot)

U.S. to share up to 60 million AstraZeneca vaccine doses globally: White House

By Andrea Shalal

WASHINGTON (Reuters) – The United States will start to share up to 60 million doses of AstraZeneca Plc’s coronavirus vaccine with other countries as soon as the next few weeks, the White House said on Monday.

White House Press Secretary Jen Psaki said the United States would release the doses to other countries as they become available.

She said there could be 10 million doses cleared for export “in coming weeks.” About 50 million more doses are currently being produced and could ship in May and June.

“Right now we have zero doses available of AstraZeneca,” Psaki said, noting that U.S. regulators still need to review the quality of those already produced.

Psaki said the Biden administration is still deciding what the process will be to determine where and how it will share the vaccine.

“We will consider a range of options from our partner countries and, of course, much of that will be through direct relationships,” she said.

The AstraZeneca vaccine has not yet been authorized for U.S. use by the Food and Drug Administration.

The Biden administration in March said it would send roughly 4 million doses of the British drugmaker’s vaccine to Canada and Mexico, and is under growing pressure now to expand sharing of its stockpile with India and other countries.

India has become the latest epicenter of the pandemic, threatening to overwhelm its healthcare system.

An AstraZeneca spokeswoman could not comment on specifics of the arrangement, but said the doses were part of its supply commitments to the U.S. government. “Decisions to send U.S. supply to other countries are made by the U.S. government,” she said.

The Associated Press earlier on Monday reported the doses would be shared in coming months following their clearance by the FDA.

The AP reported that the doses were made at the Emergent BioSolutions facility in Baltimore, which came under harsh criticism for a long list of cleanliness and manufacturing problems found during an FDA inspection.

AstraZeneca is no longer making vaccine at that plant after a batch of Johnson & Johnson’s vaccine was ruined by contamination with ingredients from the AstraZeneca shot.

J&J is now overseeing production of its vaccine at the Emergent plant.

(Additional reporting by Susan Heavey, Caroline Humer and Michael Erman; Editing by Tim Ahmann and Bill Berkrot)

AstraZeneca vaccine safe and effective in new trial data

FRANKFURT/LONDON (Reuters) – AstraZeneca’s COVID-19 vaccine developed with Oxford University was 79% effective in preventing symptomatic illness in a large trial in Chile, Peru and the United States, the company said on Monday, paving the way for it to apply for U.S. approval.

The vaccine was also 100% effective against severe or critical disease and hospitalization, and was safe, the partners said on Monday, releasing results of the late-stage human trial study of more than 32,000 volunteers across all age groups.

The data will give credence to the British shot after results from earlier, separate late-stage studies raised questions about the robustness of the data.

It will also help to allay safety concerns that have disrupted its use in the European Union after a small number of reports of rare blood clots in people who received the vaccine.

After briefly halting its use, many European countries have resumed using the shot in their inoculation programs after a regional regulator said it was safe, while several country leaders are also taking the vaccine to boost confidence.

AstraZeneca said an independent safety committee conducted a specific review of the blood clots in the U.S. trial, as well as cerebral venous sinus thrombosis (CVST), which is an extremely rare blood clot in the brain, with the help of an independent neurologist.

The London-listed company said the panel found “no increased risk of thrombosis or events characterized by thrombosis among the 21,583 participants receiving at least one dose of the vaccine. The specific search for CVST found no events in this trial.”

“These results are great news as they show the remarkable efficacy of the vaccine in a new population and are consistent with the results from Oxford-led trials,” Andrew Pollard, who runs the Oxford Vaccine Group, said.

AstraZeneca said it was preparing to submit the data to the U.S. Food and Drug Administration and for a launch in the United States should it win Emergency Use Authorization.

University of Oxford professor Sarah Gilbert told BBC radio that work to prepare the submission will take a few weeks.

The efficacy read-out was above a rate of about 60%, cited by the European Union’s drugs regulator in its December recommendation.

It was, however, in line with the maximum efficacy found by Britain’s Medicines and Healthcare products Regulatory Agency (MHRA), based on cases with a three-month gap between the first and the second dose.

In the trial, participants received either two standard doses of the Oxford-AstraZeneca vaccine or a placebo vaccine, at a four-week interval.

Amongst participants in the interim analysis, about 79% were white/Caucasian, 8% black/African American, 4% native American and 4% Asian, and 22% of participants were Hispanic, the company said.

About 20% of participants were 65 years and over, and approximately 60% had co-morbidities associated with an increased risk for progression of severe COVID-19, such as diabetes, severe obesity or cardiac disease.

(Reporting by Ludwig Burger in Frankfurt, Pushkala Aripaka and Muvija M in Bengaluru; Editing by Josephine Mason, Mark Potter, Sherry Jacob-Phillips and Edmund Blair)

Keep using AstraZeneca vaccine, WHO urges world

By Emma Farge

GENEVA (Reuters) – The World Health Organization (WHO) exhorted the world to keep administering AstraZeneca’s COVID-19 shots on Friday, adding its endorsement to that of European and British regulators after concerns over blood clotting.

“We urge countries to continue using this important COVID-19 vaccine,” WHO Director General Tedros Adhanom Ghebreyesus told a news conference in Geneva.

He was speaking after the global health body’s vaccine safety panel said available data about the AstraZeneca shot did not point to any overall increase in clotting conditions.

European and British regulators also said this week that the benefits of AstraZeneca’s shot outweighed the risks, prompting various nations to lift their suspensions.

“The AstraZeneca vaccine is especially important because it accounts for more than 90% of the vaccines being distributed through COVAX,” Tedros added, referring to a WHO-led global vaccine-sharing scheme.

“There is no question. COVID-19 is a deadly disease, and the Oxford-AstraZeneca vaccine can prevent it. It’s also important to remember that COVID-19 itself can cause blood clots and low platelets.”

The WHO’s global advisory committee on vaccine safety said in a statement that the AstraZeneca vaccine had a “positive benefit-risk profile” and “tremendous potential” to prevent infections and reduce deaths.

The WHO panel of 12 independent experts, who met virtually on Tuesday and on Thursday, reviewed safety data from Europe, the United Kingdom, India, and WHO’s global database.

“While very rare and unique thromboembolic events in combination with thrombocytopenia, such as cerebral venous sinus thrombosis (CVST), have also been reported following vaccination with the AstraZeneca COVID-19 vaccine in Europe, it is not certain that they have been caused by vaccination,” it said.

(Reporting by Michael Shields, Emma Farge and Stephanie Nebehay; Writing by Andrew Cawthorne; Editing by Hugh Lawson)

U.S. plans to send four million doses of AstraZeneca vaccine to Mexico, Canada

By Jeff Mason

WASHINGTON (Reuters) – The United States plans to send roughly 4 million doses of AstraZeneca’s COVID-19 vaccine that it is not using to Mexico and Canada in loan deals with the two countries, an administration official told Reuters on Thursday.

Mexico will receive 2.5 million doses of the vaccine and Canada will receive 1.5 million doses, the official said.

“This virus has no borders,” the official told Reuters on condition of anonymity. “We only put the virus behind us if we’re helping our global partners.”

The Biden administration has come under pressure from allies worldwide to share vaccine, particularly from AstraZeneca, which is authorized for use in other countries but not yet in the United States.

AstraZeneca has millions of doses made in a U.S. facility, and has said that it would have 30 million shots ready at the beginning of April. The company’s shares rose slightly on the news.

The deal to share the vaccine, which is still being finalized, does not affect President Joe Biden’s plans to have vaccine available for all adults in the United States by the end of May, the official said. The deal is likely to be announced publicly in the coming days.

Two officials said the vaccine would be delivered in “short order” once the deal was completed, but they declined to give a more specific timetable.

The “releasable” vaccines are ready to be used once they arrive. Under the deal, the United States will share doses with Mexico and Canada now with the understanding that they will pay the United States back with doses in return. The official said that would take place later this year.

The United States had no plans to share the vaccine with other countries at this time, he said.

“They are our neighbors, they are our partners,” the official said about Mexico and Canada. Mexican President Andres Manuel Lopez Obrador had requested the vaccine previously.

Biden has said if the United States has a surplus of vaccine, it will share it with the rest of the world.

The official noted that the United States has pledged $4 billion to the COVAX vaccine facility that aims to deliver coronavirus vaccines to poor countries.

(Reporting by Jeff Mason; Editing by Heather Timmons and Alistair Bell)

Thailand sticks with AstraZeneca vaccine after safety scare

By Panarat Thepgumpanat

BANGKOK (Reuters) – Thailand will start using the AstraZeneca COVID-19 vaccine on Tuesday after a brief delay over safety concerns, officials said, with Prime Minister Prayuth Chan-ocha and cabinet members due to be first in line to get shots.

Thailand was on Friday the first country outside of Europe to suspend use of the AstraZeneca shot, on which its mass vaccination campaign is heavily reliant.

Authorities in Ireland, Denmark, Norway, Iceland and the Netherlands have halted their use of the vaccine over blood clotting issues, while Indonesia has decided to hold off until a World Health Organization review.

Thailand has much riding on the vaccine’s safety and efficacy and the country will from June be one of its regional manufacturers. Thailand has reserved the first 61 million doses for its population.

Thai Health Minister Anutin Charnvirakul said many countries had confirmed there were no blood clot issues from the AstraZeneca shot.

“The prime minister had expressed his intention and that he was ready to be given a vaccine to build confidence for the people,” Anutin said in a statement.

He said an expert panel had agreed it should be administered and some senior medical professors would also receive it on Tuesday to demonstrate their confidence in the vaccine.

AstraZeneca said on Sunday it had reviewed data from more than 17 million people vaccinated in the United Kingdom and European Union, which showed “no evidence of an increased risk of pulmonary embolism, deep vein thrombosis or thrombocytopenia”.

Thailand has imported AstraZeneca vaccines in addition to 200,000 doses of Sinovac’s CoronaVac. A further 800,000 CoronaVac doses would arrive on March 20, followed by a million more in April, health officials said.

Anutin on Monday said Thailand hopes to procure 5 million more CoronaVac doses and is negotiating with other vaccine manufacturers that can make deliveries before locally produced AstraZeneca shots are available.

(Reporting by Panarat Thepgumpanat and Orathai Sriring; Writing by Martin Petty; Editing by Ed Davies and Nick Macfie)

WHO tries to quash nervousness about AstraZeneca vaccine

By Emma Farge and Emilio Parodi

GENEVA/MILAN/SOFIA (Reuters) – The World Health Organization squarely endorsed AstraZeneca’s coronavirus vaccine on Friday, as Thailand joined a number of smaller European countries in suspending use of the shot because of sporadic reports of blood clots among recipients.

Bulgaria also joined Denmark, Norway and Iceland, which all stopped using the vaccine on Thursday. Austria, Italy, Luxembourg, Estonia, Lithuania and Latvia stopped using certain batches.

“Until all doubts are dispelled…, we are halting inoculations with this vaccine,” Bulgarian Prime Minister Boyko Borissov said.

His health minister, Kostadin Angelov, said a 57-year-old woman had died of heart failure 15 hours after receiving an AstraZeneca shot, but urged those already inoculated to stay calm.

“We do not have any official data that proves a causal connection,” he said.

That line was reinforced by the WHO, which is keenly aware that AstraZeneca’s shot is by far the cheapest and most high-volume launched so far, and set to be the mainstay of vaccination programs in much of the developing world.

Spokeswoman Margaret Harris said the vaccine was “excellent”.

“It’s very important to understand that, yes, we should continue to be using the AstraZeneca vaccine,” she told a briefing. “All that we look at is what we always look at: Any safety signal must be investigated.”

The EU regulator, the European Medicines Agency (EMA), said on Wednesday that there had been 22 reports of embolisms from blood clots among 3 million people who had received the vaccine – no more than in the general population – but Bulgaria said it wanted to see that guidance in written form.

‘THIS NEEDS TO BE EXPLAINED’

Experts point to the difficulty of putting risks in perspective for a wider public that may be spooked by negative headlines.

In Sicily, where two people died shortly after being vaccinated, the regional health administrator said 7,000 inoculation appointments had been cancelled as a result.

Silvestro Scotti, a family doctor in Naples and head of the Italian Federation of General Practitioners, said he had been bombarded all day with inquiries from people nervous about getting the AstraZeneca shot.

“The crazy thing is that, even if the correlation between the vaccine and blood clots were proved, it would be a rate of 0.007 out of a thousand,” he said.

“To give an example: the birth control pill, which is used widely and doesn’t worry anyone, has a proven risk rate of 0.6 in a thousand. Even in the worst-case scenario, the risk/benefit ratio for this vaccine is extraordinarily favorable. That needs to be explained to people.”

The WHO’s Harris said 268 million doses of COVID-19 vaccines from various developers had been administered worldwide without being shown to have caused a single death.

In France, where distrust of vaccination is long-established, only 43% said they trusted the AstraZeneca shot in a Harris Interactive poll conducted on March 11-12, while 55% said they trusted COVID-19 vaccines in general.

Germany has also had to contend with substantial skepticism, to the extent that Health Minister Jens Spahn suggested that the AstraZeneca shot be given to the police force and army, after some health and other frontline workers baulked at receiving it.

However, German authorities’ main concern has been lack of supply, rather than lack of acceptance, as social and economic restrictions to limit transmission take their toll.

One doctor administering vaccinations in Berlin said recipients were now asking far fewer questions about the vaccine than two weeks ago.

(Additional reporting by Stephanie Nebehay in Geneva, Crispian Balmer in Rome, Paul Carrel in Berlin, Tsvetelia Tsolova in Sofia, Matthias Blamont in Paris; Writing by Kevin Liffey; Editing by Mark Heinrich)

Governments support AstraZeneca shot after South Africa halts roll-out

By Guy Faulconbridge and Kate Holton

LONDON (Reuters) – Western governments rushed to offer support for the AstraZeneca COVID-19 vaccination after South Africa halted its roll-out when research showed it offered minimal protection against mild infection from a variant spreading there.

The arrival of vaccines has given hope that scientists can tame a pandemic that has killed 2.3 million people worldwide. But if vaccines are less effective against new variants, they may need to be tweaked and people may need booster shots.

South Africa announced its pause after researchers from the University of Witwatersrand and the University of Oxford found that the AstraZeneca vaccine provided only minimal protection against mild or moderate infection from the B.1.351 variant, now the dominant form of the virus in that country.

The research is not yet peer reviewed and did not provide data on older people most likely to die or need hospitalization. There was no data on whether the vaccine would prevent severe illness, and researchers said that was still possible.

“This study confirms that the pandemic coronavirus will find ways to continue to spread in vaccinated populations, as expected,” said Andrew Pollard, chief investigator on the Oxford vaccine trial.

“But, taken with the promising results from other studies in South Africa using a similar viral vector, vaccines may continue to ease the toll on health care systems by preventing severe disease.”

SERIOUS INFECTIONS

French Health Minister Olivier Veran voiced support for the AstraZeneca vaccine, arguing it provided sufficient protection against “nearly all the variants” of the virus.

German Health Minister Jens Spahn said current evidence suggests all three vaccines approved in Europe – which include AstraZeneca – provided effective protection against serious infections.

Britain and Australia urged calm, citing evidence that the vaccines prevented grave illness and death, while AstraZeneca said it believed its vaccine could protect against severe disease.

“We think that both the vaccines that we’re currently using are effective in, as I say, in stopping serious disease and death,” British Prime Minister Boris Johnson told reporters. Britain also uses the Pfizer shot.

“We also think in particular in the case of the Oxford AstraZeneca vaccine that there’s good evidence that it is stopping transmission, as well, I think 67% reduction in transmission.”

Australia is expected approve the use of the AstraZeneca vaccine within days and expressed confidence in it.

“There is currently no evidence to indicate a reduction in the effectiveness of either the AstraZeneca or Pfizer vaccines in preventing severe disease and death. That is the fundamental task, to protect the health,” Health Minister Greg Hunt said.

But if vaccines do not work as effectively as hoped against new and emerging variants, then the world could be facing a much longer – and more expensive – battle against the virus than previously thought.

The AstraZeneca vaccine was the big hope for Africa as it is cheap and easy to store and transport. South Africa, which had hoped to roll out the AstraZeneca shot this month, is storing around 1 million doses it has received from the Serum Institute of India.

The B.1.351 variant dominant in South Africa, also known as 20I/501Y.V2, is also circulating in at least 40 other countries, including the United States. Other major variants include one first found in Britain, known as 20I/501Y.V1, and one found in Brazil known as P.1.

Austria warned against non-essential travel to its Alpine province of Tyrol because of an outbreak of the South African variant there. Cases were also detected north of Paris, forcing one school to close.

VACCINE SHOCK

An analysis of infections by the South African variant showed there was only a 22% lower risk of developing mild-to-moderate COVID-19, more than 14 days after being vaccinated with the AstraZeneca shot, versus those given a placebo.

Protection against moderate-severe disease, hospitalization or death could not be assessed in the study of around 2,000 volunteers who had a median age of 31, as the target population were at such low risk.

Professor Shabir Madhi, lead investigator on the AstraZeneca trial in South Africa, said the vaccine’s similarity to another produced by Johnson & Johnson, which reduced severe disease by 85%, suggested it would still prevent serious illness or death.

“There’s still some hope that the AstraZeneca vaccine might well perform as well as the Johnson & Johnson vaccine in a different age group demographic that I address of severe disease,” he told BBC radio.

Sarah Gilbert, professor of vaccinology at the University of Oxford, said efforts were under way to develop a new generation of booster shot vaccines that will allow protection against emerging variants.

“This is the same issue that is faced by all of the vaccine developers, and we will continue to monitor the emergence of new variants that arise in readiness for a future strain change.”

(Reporting by Guy Faulconbridge and Kate Holton; editing by Michael Holden, Angus MacSwan, Nick Macfie and Giles Elgood)