India, big vaccine exporter, now vaccine exporter as COVID-19 cases soar

By Alasdair Pal and Krishna N. Das

NEW DELHI (Reuters) -India on Tuesday said it will fast-track emergency approvals for COVID-19 vaccines authorized by Western countries and Japan, paving the way for possible imports of Pfizer, Johnson & Johnson, and Moderna shots.

The move, which will exempt companies from carrying out local safety trials for their vaccines, follows the world’s biggest surge in cases in the country this month.

Since April 2, India has reported the highest daily tallies of infections. It reported 161,736 cases on Tuesday, taking the total to 13.7 million, while deaths rose by 879 to 171,058.

On Tuesday, India’s richest state Maharashtra, which accounts for about a quarter of the country’s cases, said it would impose stringent restrictions from Wednesday to try to contain the spread.

India has the biggest global vaccine manufacturing capacity and had exported tens of millions of doses before its own demand skyrocketed and led to a shortage in some states.

Dozens of poor countries have relied on Indian exports to run their inoculation drives.

The health ministry said vaccines authorized by the World Health Organization or authorities in the United States, Europe, Britain and Japan could be granted emergency use approval in India.

“If any of these regulators have approved a vaccine, the vaccine is now ready to be brought into the country for use, manufacture and fill-and-finish,” Vinod Kumar Paul, a senior government health official, told a news conference.

“We hope and we invite the vaccine makers such as Pfizer, Moderna, Johnson & Johnson and others … to be ready to come to India as early as possible.”

Pfizer said it would work towards bringing its vaccine to India after withdrawing its application in February.

U.S. federal health agencies on Tuesday recommended pausing use of the J&J shot after six women under age 50 developed rare blood clots after receiving it.

India has administered more than 108 million vaccine doses, sold more than 54.6 million vaccine doses abroad and gifted more than 10 million to partner countries.

It is currently using the AstraZeneca shot and a homegrown vaccine for its own immunization drive, and this week approved Russia’s Sputnik V shot for emergency use.

RALLIES, RELIGIOUS GATHERINGS

The jump in India’s infections, for which Health Minister Harsh Vardhan acknowledged widespread failure to heed curbs on movement and social interaction, has prompted calls for the government to cancel huge public events.

Still, hundreds of thousands of devout Hindus are set to bathe in the Ganges river on Wednesday, the third key day of the weeks-long Kumbh Mela – or pitcher festival.

Nearly a million bathed in the Ganges on Monday in the belief that its waters would wash away their sins. More than 100 tested positive for COVID-19 in random testing of around 18,000 attendees, media said.

Similar concerns of a spike in cases were sparked by mass election rallies by Prime Minister Narendra Modi’s party and opposition groups during polls in four states and one federally run region.

At one rally in the eastern state of West Bengal, a key political prize, Home Minister Amit Shah posted Twitter pictures of meetings with crowds of supporters while unmasked.

DEADLY SPREAD

The second wave of infections, which began in India’s major cities, is increasingly spreading into the hinterland, where healthcare facilities are often rudimentary.

In Raipur, the capital of Chhattisgarh state known for its large tribal population, the main government hospital’s morgue was struggling to keep up, said joint director Dr Vineet Jain.

“All oxygenated and ICU beds are full in our set-up,” he told Reuters.

“Around 50 dead bodies are laying, we have a shortage of space. Some private hospitals do not have space to keep the dead bodies so they also send the bodies to us.”

India is currently reporting around double the daily cases of the United States and Brazil, the two other worst affected countries, though its daily death toll is lower.

India’s total infections rank after only the United States, having overtaken Brazil on Monday.

(Reporting by Krishna N. Das and Alasdair Pal in New Delhi and Jatindra Dash in Bhubaneswar; Editing by Nick Macfie, Ana Nicolaci da Costa and John Stonestreet)

Pfizer, BioNTech seek U.S. emergency nod for COVID-19 vaccine in adolescents

By Michael Erman and Mrinalika Roy

(Reuters) – Pfizer Inc and its German partner BioNTech SE on Friday asked U.S. regulators to allow the emergency use of their vaccine in adolescents aged 12 to 15.

The vaccine is currently authorized for emergency use in the United States for people aged 16 and up. The companies said on Friday that they requested an expansion of the authorization from the U.S. Food and Drug Administration to include the younger age group.

In March, the drugmakers said the vaccine was found to be safe, effective and produced robust antibody responses in 12- to 15-year old’s in a clinical trial.

It is unclear how long the regulator will take to review the data from the trial, although U.S. Centers for Disease Control director Rochelle Walensky told ABC news on Thursday that she expects the vaccine to be authorized for 12 to 15 year olds by mid-May.

It is also unclear whether the regulator will require a meeting of the independent advisory board that recommended the original authorization in order for the companies to receive the nod in the younger age group.

Moderna Inc and Johnson & Johnson are also testing their vaccines in 12- to 18-year old’s, and data from Moderna’s trial could come soon.

Pfizer and Moderna have also launched trials in even younger children, aged six months to 11 years old. Both companies have said they hope to be able to vaccinate children under 11 as soon as early 2022.

Inoculating children and young people is considered a critical step toward reaching herd immunity and taming the pandemic, according to many experts.

Pfizer and BioNtech said they plan to ask other regulatory authorities globally to allow the use of their vaccine in 12- to 15-year old’s in the coming days.

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)

Pfizer, BioNTech launch COVID-19 vaccine trial in kids under 12

By Michael Erman

(Reuters) – Pfizer Inc and German partner BioNTech SE began testing their COVID-19 vaccine in children under 12, with hopes of expanding vaccination to that age range by early 2022, the U.S. drugmaker said on Thursday.

The first volunteers in the early-stage trial were given their first injections on Wednesday, Pfizer spokesperson Sharon Castillo said.

The Pfizer/BioNTech vaccine was authorized by U.S. regulators in late December for people age 16 and older. Nearly 66 million doses of the vaccine had been administered in the United States as of Wednesday morning, according to data from the U.S. Centers for Disease Control and Prevention.

The pediatric trial, which will include children as young as 6 months, follows a similar one launched by Moderna Inc last week.

Only the Pfizer/BioNTech vaccine is being used in 16- and 17-year-olds in the United States. Moderna’s shot was cleared for those age 18 and older, and no COVID-19 vaccine has been authorized in younger kids yet.

Pfizer and BioNTech plan to initially test the safety of their two-shot vaccine at three different dosages – 10, 20 and 30 micrograms – in a 144-participant Phase I/II trial.

They plan to later expand to a 4,500-participant late-stage trial in which they will test the safety, tolerability and immune response generated by the vaccine, likely by measuring antibody levels in the young subjects.

Castillo said the companies hope to have data from the trial in the second half of 2021.

Meanwhile, Pfizer has been testing the vaccine in children from age 12 to 15. The company expects to have data from that trial in the coming weeks, Castillo said.

(Reporting by Michael Erman; Additional reporting by Julie Steenhuysen in Chicago; Editing by Bill Berkrot)

Pfizer begins early-stage study of oral COVID-19 drug

(Reuters) – Pfizer Inc has started an early-stage U.S. trial of an oral COVID-19 antiviral therapy that could be prescribed to patients at the first sign of infection, the company said on Tuesday.

The drugmaker, which developed the first authorized COVID-19 vaccine in the U.S. with Germany’s BioNTech SA, said the antiviral candidate showed potent activity against SARS-CoV-2, the virus that causes COVID-19, in lab studies.

Pfizer’s candidate, named PF-07321332, is a protease inhibitor that prevents the virus from replicating in cells.

Protease inhibitors have been effective at treating other viral pathogens such as HIV and hepatitis C virus, both on their own and in combination with other antivirals, the company said.

Pfizer believes this class of molecules may provide well-tolerated treatments against COVID-19, as currently marketed therapeutics that work on the same lines have not reported safety concerns.

The company is also studying an intravenously administered antiviral candidate in an early-stage trial in hospitalized COVID-19 patients.

“Together, the two (oral and intravenous candidates) have the potential to create an end-to-end treatment paradigm that complements vaccination in cases where disease still occurs,” Pfizer’s Chief Medical Officer Mikael Dolsten said in a statement.

Pfizer’s candidate is behind two other oral antiviral therapies, which are in mid-stage trials – the first being developed by rival Merck & Co with Ridgeback Bio, and a second from Roche Holding and Atea Pharmaceuticals.

Gilead Sciences’ remdesivir is currently the only U.S. Food and Drug Administration-approved drug for the treatment of COVID-19.

The FDA has granted an emergency authorization to intravenous therapies from Eli Lilly – bamlanivimab alone and in combination with etesevimab, and a combination therapy from Regeneron.

(Reporting by Vishwadha Chander in Bengaluru; Editing by Shailesh Kuber)

Madrid halting COVID-19 vaccinations due to supply delays

MADRID (Reuters) – Delays to COVID-19 vaccine shipments have forced authorities in Madrid to halt inoculations and are threatening supplies in Catalonia, Spanish officials said on Wednesday.

The Madrid region has ceased first vaccinations for at least this week and next and was using the few doses it has to administer second shots to those who have had the first one, said deputy regional government chief Ignacio Aguado.

“We need more doses and we need them now,” he told reporters on Wednesday, urging newly appointed Health Minister Carolina Darias to act quickly to secure the shots.

U.S. pharmaceutical giant Pfizer said last week there would be a temporary slow down in shipments to the European Union in late January caused by changes to manufacturing processes to ultimately boost output.

The announcement angered some EU governments and the executive European Commission due to the slow pace of vaccine roll outs in the 27-nation bloc.

It is also in dispute with Anglo-Swedish pharmaceutical firm AstraZeneca, which developed its shot with Oxford University and notified the EU on Friday that it could not meet supply targets for the first quarter of the year.

Spain’s 14-day incidence of the virus hit a record 900 cases per 100,000 people on Wednesday and the Health Ministry reported 40,285 new infections and 492 deaths.

Officials in Madrid and Catalonia said at the current pace it would be impossible to reach the national target of 70% of Spain’s 47 million population vaccinated by July.

Catalan health secretary Josep Maria Argimon said the region would use up all its stockpile of vaccines in the coming days and will have to administer second shots later than planned due to supply delays, citing an undelivered shipment of the Moderna vaccine scheduled for this week as one example.

The affluent northeastern region will issue a new request for 30,000 vaccine doses that it expects to administer starting on Feb. 4, Argimon told a news briefing.

Spain has administered just over 1.3 million doses to a priority group of care-home residents and frontline medics, around 77% of its current stocks.

(Reporting by Inti Landauro, Emma Pinedo, Nathan Allen and Joan Faus; Editing by Mark Heinrich and Janet Lawrence)

New York governor asks Pfizer to directly sell COVID-19 vaccine doses

By Kanishka Singh

(Reuters) – New York Governor Andrew Cuomo asked Pfizer Inc Chief Executive Albert Bourla on Monday if the state could buy COVID-19 vaccine doses directly from the U.S. drugmaker.

Pfizer, however, told Reuters that such a proposal would first require approval by the U.S. Department of Health and Human Services.

“With hospitalizations and deaths increasing across the country this winter, we are in a footrace with the virus, and we will lose unless we dramatically increase the number of doses getting to New Yorkers,” Cuomo said in a letter to Pfizer’s CEO.

Cuomo said he was appealing to Pfizer directly as the company was “not bound by commitments” that Moderna Inc made as part of Operation Warp Speed, the U.S. government’s program to distribute COVID-19 vaccines.

No state has purchased vaccines directly from the producer. Cuomo’s letter did not state how many doses he was seeking or how he would pay for it.

Pfizer said it was open to collaborating with the U.S. Department of Health and Human Services in a way that would ensure quick vaccine distribution to as many Americans as possible.

(Reporting by Kanishka Singh in Bengaluru; Editing by Howard Goller)

Mexico aims to make up for Pfizer vaccine shortfall with others

MEXICO CITY (Reuters) – Mexican President Andres Manuel Lopez Obrador said on Monday the government aimed to compensate for a reduction in deliveries of COVID-19 vaccine doses from Pfizer Inc with those from other providers.

The World Health Organization (WHO) said on Monday it was in advanced talks with Pfizer about including its vaccine in the agency’s portfolio of shots to be shared with poorer countries.

Mexico had been expecting weekly deliveries of some 400,000 doses of the Pfizer vaccine developed with Germany’s BioNTech SE. As a result of the U.S. drugmaker’s WHO agreements, Mexico would for now only be receiving half that total, Lopez Obrador told a regular news conference.

It was not clear how long the reduction would last. Pfizer did not immediately reply to a request for comment.

The Pfizer/BioNTech vaccine is currently the only one being administered in Mexico, which has reported the fourth-highest death toll from the pandemic worldwide.

Mexico has also signed deals to acquire vaccines from Britain’s AstraZeneca Plc and China’s CanSino Biologics. Mexico has approved the AstraZeneca shot and expects to have it by March. It is still reviewing the CanSino vaccine.

Lopez Obrador also noted Mexico was about to complete its review of a Russian vaccine, and would soon have it available, an apparent reference to the Sputnik V product.

Mexico suffered a setback to its drive to inoculate the public with the news over the weekend that the official in charge of the program, Miriam Veras Godoy, had stepped down for personal reasons, according to the health ministry.

(Reporting by Raul Cortes; Editing by Bill Berkrot)

Israel sharing COVID-19 data with Pfizer to help fine-tune vaccine rollout

JERUSALEM (Reuters) – Israel is giving weekly data updates on its COVID-19 outbreak to vaccine maker Pfizer under a collaboration agreement that may help other countries fine-tune their inoculation campaigns and achieve “herd immunity,” officials said.

Israelis began receiving first shots of the vaccine developed by Pfizer and its German partner BioNTech on Dec. 19 in one of the world’s fastest vaccination rollouts.

Israel’s Health Ministry made public most of a 20-page collaboration agreement it signed with Pfizer, which said the aim was “to determine whether herd immunity is achieved after reaching a certain percentage of vaccination coverage in Israel”.

Commercial details such as price and quantity of vaccine shots supplied were not made public, but the agreement said that Israel was relying on Pfizer to deliver enough doses at a fast enough rate to allow it to achieve “herd immunity,” meaning a sufficient portion of the population is immune to the virus.

“While this project is conducted in Israel, the insights gained will be applicable around the world and we anticipate will allow governments to maximize the public health impact of their vaccination campaigns,” BioNTech said on Monday in a statement.

This includes determining potential immunization rates needed to stop the virus from spreading, it said.

The goal, BioNTech said, was “to monitor the evolution of the epidemic over time and at different vaccination rates.”

“This will help us understand whether a potential decrease in cases and deaths can be attributed solely to direct vaccine protection or to both direct and indirect (or ‘herd’) protection,” it said.

During weekly status reports, Israel will provide Pfizer with epidemiological data such as: the number of confirmed COVID-19 cases, hospitalizations, how many patients were on ventilators, how many died, as well as an age and other demographic breakdown.

Such data was available to the public and keeps patients anonymous, Israeli officials said.

About a quarter of Israelis have received their first vaccine shot and 3.5% already got their second dose.

Still, the country is in its third lockdown with infection rates remaining high. More than half a million cases have been reported and 4,005 people have died in Israel since the pandemic began.

(Reporting by Ari Rabinovitch, Ludwig Burger, Nikolaj Skydsgaard and Steven Scheer; Editing by Alex Richardson)