WHO chief laments ‘shocking imbalance’ in COVID-19 shot distribution

GENEVA (Reuters) -There is a “shocking imbalance” in the distribution of COVID-19 vaccines worldwide and most countries do not have anywhere near enough shots to cover health workers and others at high-risk, WHO Director-General Tedros Adhanom Ghebreyesus said on Friday.

More than 700 million jabs have been administered worldwide against the disease, but 87% have gone to high income or upper middle-income countries, with low income countries receiving just 0.2%, he said.

“On average in high-income countries, almost one in four people has received a COVID-19 vaccine. In low-income countries, it’s one in more than 500,” Tedros told a briefing.

The COVAX facility has delivered nearly 38.4 million doses of COVID-19 vaccines to 102 countries across six continents, six weeks after it began to roll out supplies, the GAVI vaccine alliance and WHO said on Thursday. It aims to deliver more than 2 billion doses this year but has faced delays.

“We hope to be able to catch up during April and May. The problem is not getting vaccines out of COVAX, the problem is getting them in,” Tedros said, decrying the scarcity of supply.

The AstraZeneca shot – the mainstay of the COVAX program so far – has been hit by safety concerns after reports of blood clots in some recipients.

Australia said on Friday it had ordered more alternatives for the AstraZeneca vaccine, setting back its vaccination rollout, and Hong Kong delayed deliveries of the shot amid concern about a possible very small risk of rare blood clots.

GAVI CEO Seth Berkley, asked whether COVAX was negotiating for more doses of the vaccine being shunned by some countries, said that the Anglo-Swedish company’s supply chain had “picked up”.

He hoped that the supply of AstraZeneca vaccine made by the Serum Institute of India – whose doses are now being kept domestically for use against an accelerating epidemic – would improve over time.

“As countries decide they are going to prioritize one vaccine or another that may free up doses, and in doing we will try to make sure those doses are made available without delay, if countries are willing to make that happen,” Berkely said.

(Reporting by Stephanie Nebehay and John Revill Writing by Andrew HeavensEditing by Andrew Cawthorne and Peter Graff)

COVAX vaccines reach more than 100 countries, despite supply snags

By Stephanie Nebehay

GENEVA (Reuters) -The COVAX vaccine facility has delivered nearly 38.4 million doses of COVID-19 vaccines to 102 countries and economies across six continents, six weeks after it began to roll out supplies, according to a statement on Thursday.

The program offers a lifeline to low-income countries in particular, allowing them in the first instance to inoculate health workers and others at high risk, even if their governments have not managed to secure vaccines from the manufacturers.

But there have been some delays, the GAVI vaccine alliance and World Health Organization said in a statement.

Reduced availability of delayed some deliveries in March and April, and much of the output of the Serum Institute of India, which makes the AstraZeneca vaccine, is being kept in India, where daily infections surpassed 100,000 for the first time on Monday.

The Caribbean island of St. Lucia became the 100th country to receive vaccines through COVAX. Iran, also battling a record rate of infection, is another recent recipient.

The 102 countries reached so far include 61 benefiting from a mechanism essentially financed by donors.

WHO Director-General Tedros Adhanom Ghebreyesus on Monday called it a “travesty” that some countries still did not have enough vaccines to begin inoculating health workers and the most vulnerable.

GAVI said last month that it planned to deliver 237 million doses of the AstraZeneca vaccine – which has been produced at cost for a few dollars a dose, and does not require the advanced refrigeration of some other coronavirus vaccines – to 142 countries by the end of May.

“COVAX may be on track to deliver to all participating economies in the first half of the year, yet we still face a daunting challenge as we seek to end the acute stage of the pandemic,” GAVI chief executive Seth Berkley said in the statement.

Nonetheless, COVAX still expects to deliver at least 2 billion doses this year 2021, and to diversify the offering beyond the AstraZeneca/Oxford and Pfizer/BioNTech shots it is currently supplying.

(Reporting by Stephanie Nebehay; Editing by Kevin Liffey)

European countries may have to mix COVID-19 shots amid AstraZeneca crisis

By Matthias Blamont, Gwladys Fouche and Essi Lehto

PARIS (Reuters) – Several European countries are considering mixing up COVID-19 vaccines for citizens who received a first dose of AstraZeneca’s shot, an unprecedented move that highlights challenges for governments struggling to tame fresh rises in infections.

Vaccination programs have been upset after a small number of reports that recipients of the AstraZeneca inoculation have suffered extremely rare blood clots, leading some countries worldwide to suspend its use out of caution.

A senior official for the European Medicines Agency (EMA) said in an interview published on Tuesday there was a link between the vaccine and rare blood clots in the brain but the possible causes were still unknown.

The EMA later said in a statement that its review of the vaccine was ongoing. It will give an update on its investigation on Wednesday afternoon.

AstraZeneca has said previously its studies have found no higher risk of clots because of the vaccine, millions of doses of which have been administered worldwide.

While many countries have resumed using the shot, some have imposed age restrictions.

In many instances, this has left officials scratching their heads over what to do for people who received a first dose of AstraZeneca but are no longer eligible under the new rules.

While the numbers are small compared with the tens of millions being inoculated across the region, the decision is significant because it has not been tested in late-stage human trials.

Any divergence to the EMA’s marketing authorization would also be considered as “off label use”, meaning it would not be approved by the regulator and leave individual countries responsible for any possible side-effects.

The EMA had no immediate comment when asked about mixing and matching vaccines and referred to the briefing later on Wednesday.

Some experts say that, because all of the vaccines target the same outer “spike” protein of the virus, they could work together to train the body to fight off the virus. There is no evidence it will be as effective.

Germany was the first European country to recommend on April 1 that people under 60 who have had a first AstraZeneca shot should receive a different product for their second dose.

Norway will decide whether to resume using AstraZeneca’s vaccine or rely on alternatives by April 15.

“The outcome is either you get one vaccine, the AstraZeneca vaccine … or you get a booster vaccine with other types of vaccines,” Sara Viksmoen Watle, a senior physician at the Norwegian Institute of Public Health, told Reuters.

Norwegian authorities are also waiting for the results of a British trial launched in February to explore mixing doses of Pfizer and AstraZeneca vaccines. The timing of the data is not known.

Britain said late last year it would allow people to be given shots of different COVID-19 vaccines on rare occasions, but it has not yet had to do so.

Finland, which resumed using the AstraZeneca vaccine from March 29, but will only give it to people aged 65 and over, said it would wait for the EMA’s conclusions before making a recommendation. It will have to start giving second doses by mid-April.

In France, where the vaccine can now only be used for those aged 55 or older, the issue affects hundreds of thousands of people.

A top health advisory body in charge of defining the use of vaccines, the Haute Autorité de la Santé (HAS), is also contemplating deploying a messenger RNA (mRNA) vaccine produced by Pfizer-BioNTech or Moderna as a second dose, according to two sources aware of the organization’s plans.

A formal decision has not been yet taken, however, as experts await more data, notably from Britain, one of the sources added. France has until early May, which marks 12 weeks after the first doses were administered.

The HAS had no comment.

Back in February, it said there was no data to assess interchangeability of AstraZeneca’s vaccine and therefore advised that those who had already received a first dose should not get a different shot when vaccinated for the second time.

“We are left guessing and that makes me and other colleagues feel very uncomfortable,” said Charlotte Senechal, a 52-year-old hospital nurse working in Strasbourg, eastern France.

U.S. administers 168.6 million doses of COVID-19 vaccines: CDC

(Reuters) – The United States has administered 168,592,075 doses of COVID-19 vaccines in the country as of Tuesday morning and distributed 219,194,215 doses, the U.S. Centers for Disease Control and Prevention said.

The tally is for Moderna, Pfizer/BioNTech, and Johnson & Johnson’s vaccines as of 6:00 a.m. ET on Tuesday, the agency said.

According to the tally posted on April 5, the agency had administered 167,187,795 doses of the vaccines, and distributed 207,891,395 doses.

The agency said 108,301,234 people had received at least one dose while 63,016,976 people are fully vaccinated as of Tuesday.

A total of 7,748,620 vaccine doses have been administered in long-term care facilities, the agency said.

(Reporting by Manojna Maddipatla in Bengaluru)

Southwest recalls 209 pilots as travel demand recovers

(Reuters) -Southwest Airlines has recalled 209 pilots from a voluntary extended leave program to support its summer schedule, the company said on Monday, as airlines prepare for a recovery in demand as more Americans receive COVID-19 vaccines.

The pilots will return to active status on June 1 and will then complete all of the necessary requalification training requirements before they fly with passengers.

Among other major U.S. carriers, Delta Air Lines and American Airlines have also recalled pilots who were sidelined during the pandemic.

United Airlines, which reached a deal with its union to keep pilots active throughout the downturn, said last week it was preparing to hire about 300 pilots as travel demand rebounds.

Low-cost airlines have also recalled pilots and are hiring again.

(Reporting by Tracy Rucinski; Editing by Leslie Adler and Howard Goller)

Pfizer, Moderna COVID-19 vaccines highly effective after first shot in real-world use, -U.S. study

By Ankur Banerjee and Vishwadha Chander

(Reuters) – COVID-19 vaccines developed by Pfizer Inc with BioNTech SE and Moderna Inc reduced the risk of infection by 80% two weeks or more after the first of two shots, according to data from a real-world U.S. study released on Monday.

The risk of infection fell 90% by two weeks after the second shot, the study of just under 4,000 vaccinated U.S. healthcare personnel and first responders found.

The study by the U.S. Centers for Disease Control and Prevention (CDC) evaluated the vaccines’ ability to protect against infection, including infections that did not cause symptoms. Previous clinical trials by the companies evaluated their vaccine’s efficacy in preventing illness from COVID-19.

The findings from of the real-world use of these messenger RNA (mRNA) vaccines confirm the efficacy demonstrated in the large controlled clinical trials conducted before they received emergency use authorizations from the U.S. Food and Drug Administration.

The study looked at the effectiveness of the mRNA vaccines among 3,950 participants in six states over a 13-week period from Dec. 14, 2020 to March 13, 2021.

“The authorized mRNA COVID-19 vaccines provided early, substantial real-world protection against infection for our nation’s healthcare personnel, first responders, and other frontline essential workers,” CDC Director Rochelle Walensky said in a statement.

The new mRNA technology is a synthetic form of a natural chemical messenger being used to instruct cells to make proteins that mirror part of the novel coronavirus. That teaches the immune system to recognize and attack the actual virus.

The CDC study comes weeks after real-world data from Israel suggested that the Pfizer/BioNTech vaccine was 94% effective in preventing asymptomatic infections.

Some countries, including Britain and Canada, are allowing extended gaps between doses that differ from how the vaccines were tested in clinical trials in order to alleviate supply constraints. In the trials, there was a three-week gap between Pfizer shots and four weeks for the Moderna vaccine.

In Britain, authorities said in January that data supported its decision to move to 12 weeks between the first and second Pfizer/BioNtech shots. Pfizer and its German partner have warned that they had no evidence to prove that.

(Reporting by Ankur Banerjee and Vishwadha Chander in Bengaluru; Editing by Peter Henderson and Bill Berkrot)

EU export restrictions on COVID shots would be ‘lose-lose’ situation: Pfizer executive

By John Miller

ZURICH (Reuters) – European Union export restrictions on COVID-19 vaccines would result in a ‘lose-lose’ situation for everyone, including EU members, a Pfizer executive said, a day after the bloc tightened oversight of shot deliveries beyond its borders.

The EU’s action would give it greater scope to block shipments to countries with higher inoculation rates such as Britain, or which are not sharing doses that they produce.

The specter of export restrictions has many concerned, given the global nature of vaccine production, in which shots have hundreds of ingredients sourced in dozens of countries. New roadblocks for shots or raw materials could disrupt pandemic-fighting efforts as the world struggles to contain a third wave of infections, companies fear.

“We have observed these recent developments with concern,” Sabine Bruckner, Swiss country manager for Pfizer, said at a Swiss government press conference on Thursday.

“Our executive leadership has been in direct contact with the European Union. Our position has been laid out, we are very critical, we can’t support it at all,” she added.

“Should it really come to export restrictions, that would be a ‘lose-lose’ situation for everyone, also for the members of the European Union.”

The new rules set out by the European Commission, which oversees EU trade policy, expand existing measures aimed at ensuring planned exports by drugmakers do not threaten the bloc’s supply.

They add 17 previously exempt countries including Israel, Norway and Switzerland to the list of countries for which exports of EU-produced vaccines require licenses. Switzerland, for instance, gets its Pfizer COVID-19 shots from a plant in Belgium.

Pfizer’s Bruckner made the comments after a Swiss vaccine summit in which Health Minister Alain Berset predicted his country would receive 10.5 million vaccines from suppliers including Pfizer and Moderna by July, enough to vaccinate everybody in Switzerland who wants a shot, he said.

(Reporting by John Miller in Zurich and Philip Blenkinsop in Brussels; Editing by Elaine Hardcastle)

Alaska becomes first U.S. state to make vaccine available to everyone 16 and older

By Yereth Rosen

ANCHORAGE, Alaska (Reuters) – Alaska has become the first U.S. state to make COVID-19 vaccines available to anyone age 16 or older, eliminating eligibility requirements for people who work or live in the state.

Governor Mike Dunleavy, a Republican, announced the new rules on Tuesday for his state of about 730,000 people. More than one quarter of Alaskans have received at least one vaccine shot, second only to New Mexico, according to data from the U.S. Centers for Disease Control and Prevention.

Certain regions of Alaska are nearing a 90% vaccination rate among elderly people, officials said.

Many states are struggling to meet the vast demand for vaccines. Differing eligibility requirements have created a patchwork system, with certain states still restricting vaccines to adults 65 or older, along with people in high-risk groups.

The COVID-19 vaccines developed by Moderna and Johnson & Johnson are approved only for people age 18 and older, but younger Alaskans can receive the Pfizer vaccine.

Officials hope that making vaccinations widely available will boost the crucial tourism industry ahead of the summer.

“Alaska’s also somewhat of a seasonal state with regard to aspects of the economy,” Dunleavy said at a news conference. “We’re hoping that we can get the cruise ships back there, the tourism industry back here.”

As of Tuesday morning, more than 123 million doses of the COVID-19 vaccines had been distributed in the United States and 93.7 million shots had been administered, according to the CDC.

(Reporting by Yereth Rosen; Writing by Joseph Ax; Editing by Will Dunham)

Alabama extends mask mandate for a month, breaking with Texas, Mississippi

By Barbara Goldberg

(Reuters) – Alabama’s governor said on Thursday she was extending the state’s mask mandate for another month, heeding the advice of health experts and breaking with decisions by neighboring Mississippi and Texas earlier this week to lift their requirements.

Alabama’s mask mandate, due to expire on Friday, will remain in effect to April 9, but no longer, Governor Kay Ivey said.

“After that, it’ll be personal responsibility,” the Republican said at a briefing, adding that she plans to continue wearing her mask beyond that date. “Folks, we’re not there yet, but goodness knows we’re getting closer.”

The contrasting moves on masks in the three Southern states comes at a time when the number of new coronavirus infections, hospitalizations and deaths had been sharply falling in the United States after a surge that followed the holiday season.

About 45,000 COVID-19 patients were being treated in U.S. hospitals as of Wednesday night, compared with a peak of about 132,000 on Jan. 6.

The improving metric in part reflects an acceleration of the drive to distribute the COVID-19 vaccines that have been approved for emergency use by the U.S. Food and Drug Administration. A third authorized vaccine from Johnson & Johnson began going into arms this week.

Even so, health authorities have stressed the need for caution, urging Americans to keep wearing masks, practice social distancing and other measures to prevent the spread of the virus amid concerns that declines in new infections was plateauing with highly contagious newer virus variants widely circulating.

“Now is not the time to pull back,” Dr. Anthony Fauci, the nation’s top infectious disease official and President Joe Biden’s COVD-19 medical adviser, told MSNBC on Thursday in an interview.

“We were going in the right direction. Now is the time to keep the foot on the accelerator and not pull off,” he said, referring to the announcements that Texas and Mississippi were lifting mask mandates.

Since the pandemic reached the United States early last year, the country has recorded 28.9 million cases and more than 519,000 deaths, more than any other country in the world.

Texas, Mississippi and Alabama are near the bottom of the list of states in terms of administering vaccines, according to the U.S. Centers for Disease Control and Prevention based on the number of people per thousand who have gotten at least one dose. The governors of all three states are Republicans.

The delay in lifting the Alabama mandate will enable more of its 4.9 million residents to be inoculated after the state just administered its 1 millionth dose of vaccine, Ivey said.

Ivey did announce an end to indoor dining restrictions on restaurants and said summer camps can plan to reopen. She is also permitting senior centers to resume outdoor programs and increase the maximum number of visitors from one to two.

Among the improvements she cited was a 77% drop in COVID-19 hospitalizations from its Jan. 11 peak to its lowest level since last June.

“While I’m convinced that a mask mandate has been the right thing to do, I also respect those who object, and believe that this was a step too far in government overreach,” she said.

Even as he urged Americans to stay vigilant, Fauci expressed optimism about a gradual return to normalcy by the end of the summer or early fall if the vaccine rollout goes smoothly, the majority of Americans agree to be vaccinated and new virus variants prove to be manageable.

“It’s not going to be a light switch on and off… it’s going to be gradual,” he said.

(Reporting by Susan Heavey in Washington, Caroline Humer and Peter Szekely in New York; Writing by Barbara Goldberg; Editing by Bill Berkrot)

EU, under pressure over vaccine rollouts, considers switch to emergency approvals

By Francesco Guarascio

BRUSSELS (Reuters) – The European Commission said on Tuesday that it was considering emergency approvals for COVID-19 vaccines as a faster alternative to more rigorous conditional marketing authorizations which have been used so far.

The move would mark a big shift in approach to vaccine approvals, as it would entail using a procedure that the EU had considered dangerous and that before the COVID-19 pandemic had been reserved for exceptional authorization at national level of drugs for terminally ill patients, including cancer treatments.

The potential change comes as the EU executive and the bloc’s drug regulator come under increasing pressure for what some consider slow vaccine approvals, which have contributed to a slower rollout of COVID-19 shots in the 27-nation union, compared to the United States and former EU member Britain.

“We are ready to reflect with the member states on all possible avenues to indeed accelerate the approval of the vaccines,” an EU Commission spokesman told a news conference after the matter was discussed earlier on Tuesday at a COVID-19 meeting with EU Commission President Ursula von der Leyen.

One option could be “an emergency authorization of vaccines at EU level with shared liability among member states,” the spokesman said, adding that work on this could start very quickly if EU governments supported the idea.

It was not clear whether an EU-wide emergency authorization procedure, if agreed upon, would entail the same conditions as emergency approvals granted at national level, the commission spokesman told Reuters.

The European Medicines Agency (EMA) cannot currently issue emergency approvals but in exceptional circumstances has recommended the compassionate use of drugs before marketing authorization.

This procedure was used in April to initially authorize doctors to use Gilead’s antiviral drug remdesivir as a treatment against COVID-19. The drug was later given conditional approval by EMA.

CHANGE OF TACK

National emergency approvals are allowed under EU laws, but they force countries to take full responsibility if something goes wrong with a vaccine, whereas under the more rigorous marketing authorization, pharmaceutical companies remain liable for their vaccines.

The EU Commission had said that national emergency authorizations should not be used for COVID-19 vaccines because faster approvals could reduce regulators’ ability to check efficacy and safety data.

This could also boost vaccine hesitancy, which is already high in some countries, EU officials had said.

One senior EU official said the emergency procedure had so far usually been used at national level for terminally ill patients and the EU had instead chosen the lengthier conditional marketing authorization because with vaccines “we inject healthy people” and the risk was disproportionate.

The change of tack would come after Eastern European countries, including Hungary, Slovakia and the Czech Republic, approved or said they were considering approval of Russian and Chinese vaccines with national emergency procedures.

Britain has also used the emergency procedure to approve COVID-19 vaccines.

The EU Commission also said last month it was working on a possible fast-track approval of upgraded anti-variant vaccines, which had already been authorized and would need fewer comprehensive checks before they are made available to the public.

(Reporting by Francesco Guarascio @fraguarascio; additional reporting by Emilio Parodi; Editing by Nick Macfie and Jonathan Oatis)