The global vaccination effort, already in dire shape, faces more setbacks.

As inoculations help a sense of normalcy return in the lives of many Americans, much of the world remains gripped by the pandemic, with little hope that a significant number of vaccine doses will be made available soon.

The effort to vaccinate enough of the world’s population to get the virus under control — already a huge struggle, experts said — was set back again this week after the Serum Institute of India, the world’s largest vaccine producer, signaled that it would not be able to export doses until the end of the year.

The Serum Institute’s manufacturing capacity is at the heart of Covax, a global effort to vaccinate the populations of low- and middle-income countries. The program is already more than 140 million doses behind schedule, and the Serum Institute announcement suggested that its goal of two billion doses by the end of the year would be all but impossible to meet.

Dr. Arthur Reingold, chief of the epidemiology division at the University of California, Berkeley, said that the delay was “not surprising, given the drastic situation” in India, which has been pummeled by the virus in recent weeks.

devastating second wave of coronavirus infections, the institute has diverted all its manufacturing powers to domestic needs, falling behind on commitments to the Covax partnership as well as on bilateral commercial deals with many countries.

“It simply means that poor countries of the world, the low- and middle-income countries of the world,” Dr. Reingold said, “are going to have to wait longer to come anywhere close to the kind of vaccination coverage that we’ve achieved in some of the wealthier countries.”

About 48 percent of people in the United States have received at least one dose of a Covid-19 vaccine, according to federal data on Wednesday. In the United Kingdom, the figure is 54 percent, and in Germany, nearly 38 percent, according to the Our World in Data project at Oxford University.

But only 10 percent of people in India have received a dose of the vaccine. Just over 1 percent of people in Honduras have received a shot, and less than 1 percent have been at least partially vaccinated in Somalia.

100 million doses of Johnson & Johnson’s vaccine were now on hold as regulators checked them for possible contamination.

The Johnson & Johnson vaccine has been viewed by public health officials as an important tool to vaccinate populations that are more difficult to reach, because it requires only one dose and does not need the special low-temperature storage required by the Moderna and Pfizer-BioNTech vaccines.

The rate of vaccinations in the United States has slowed considerably in recent weeks, though about 1.8 million doses are being administered to Americans each day on average, according to a New York Times database.

President Biden announced on Monday that the United States would send 20 million doses of the three vaccines abroad. The 100 million Johnson & Johnson doses under inspection could pad the American stockpile, or be sent to help meet the dire need abroad.

Still, Dr. Reingold said that it was “time well spent” to “very carefully look at those doses and ensure that they’re safe and effective.”

View Source

Indian Vaccine Manufacturer Signals it Won’t Export Doses Before Year’s End

The vaccination woes of some of the world’s poorest nations will continue as the Serum Institute of India, a crucial manufacturing pillar in the plan to supply two billion doses of Covid-19 vaccines to low-income countries, signaled that it would not be able to provide vaccines beyond India before the year’s end.

The revelation, tucked into a statement by the vaccine manufacturing giant that attempted to deflect mounting criticism, was another setback for Covax, the global vaccine partnership for the poor. It is already more than 140 million doses behind schedule, and the Serum Institute’s announcement suggested it was all but impossible to meet the goal of two billion doses by the end of the year.

The announcement once again underscored the glaring contrast of inequality: As some of the richer nations tout levels of vaccinations that allows them to reopen their society, most of the poorer nations have barely gotten a start.

“We continue to scale up manufacturing and prioritize India,” the Serum institute of India said in the statement on Tuesday. “We also hope to start delivering to Covax and other countries by the end of this year.”

Oxford-AstraZeneca vaccine, licensed to it with the commitment that a large share would go to poor nations.

As part of its plan to have two billion doses by the end of the year, Covax has been counting on hundreds of millions of the Oxford-AstraZeneca vaccine produced by Serum Institute, as well hundreds of millions of as a second vaccine called Novavax that the company is developing.

After India’s devastating second wave of coronavirus infections, the institute diverted all its manufacturing powers to domestic needs, falling behind on commitments to the Covax partnership as well as on bilateral commercial deals with many countries. The institute played down each delay as temporary. But Tuesday’s statement makes clear it is unlikely to meet commitments before the end of the year.

So far, the Covax alliance has supplied only 65 million vaccines, spread across 124 countries, according to the World Health Organization. The W.H.O. said the global alliance was already 140 million doses behind and likely to miss another 50 million doses in June.

“Once the devastating outbreak in India recedes, we also need the Serum Institute of India to get back on track and catch up on its delivery commitments to Covax,” said Dr. Tedros Adhanom Ghebreyesus, the chief of W.H.O.

the government’s mismanagement of the crisis.

India has administered about 180 million doses of vaccines. Only about 5 percent of the country’s adult population. The vaccination rate has fallen to about 1.8 million doses a day, which means it would take the country more than three years to vaccinate 80 percent of its population.

View Source

Covid-19 Vaccines: Novavax Reports More Delays

Novavax, one of the first players in the race to vaccinate the world against Covid, delivered disheartening news on Monday, saying that its highly protective vaccine would not be authorized in the United States or Britain until at least July, and that it would not reach peak production until the end of the year.

The delays, announced during an earnings call with investors, are the latest setback for the little-known Maryland company, which was granted up to $1.6 billion from the U.S. federal government last year and whose product has shown robust results in clinical trials. Despite these wins, the company has struggled to demonstrate that it can deliver on its promise to supply the world with 2 billion doses this year. Novavax has never brought a vaccine to market in its 34-year history.

On the call, the company’s president and chief executive, Stanley C. Erck, said that the regulatory and manufacturing hurdles causing the delay have now been resolved. “Nearly all of the major challenges have been overcome, and we can clearly see the light at the end of the tunnel,” he said.

Investors did not appear to agree: By Tuesday morning, the company’s stock had fallen to $133.86, down nearly 17 percent, although it rebounded somewhat later in the day.

finalized a deal with Gavi, a public-private global vaccine partnership, to supply 1.1 billion doses of its shot to low- and middle-income countries. Novavax has struck other deals with countries like South Korea, Japan and Australia, and has set up agreements with eight production plants around the world.

In January, the company estimated that it would hit its full production capacity of 150 million doses a month by the middle of this year, a prediction it later revised after facing a shortage of supplies like filters and the giant single-use bags that are used in vaccine manufacturing. On Monday, the company delayed its estimate again, saying it expected to reach production of 100 million doses a month by the end of the third quarter, and to make 150 million a month by the fourth quarter.

One of its major manufacturing partners, the Serum Institute in India, has faced its own production and geopolitical challenges. A fire at the facility earlier this year reduced its capacity, and in April, Serum’s chief executive, Adar Poonawalla, called out the United States for restricting access to raw vaccine ingredients. And though Novavax’s deal with Serum is intended to supply the rest of the world through its arrangement with Gavi, the Indian government has banned exports of vaccines from the country as it struggles with a deadly second wave of Covid-19.

which is tracking global vaccine deals. “I think particularly for countries in South and Southeast Asia, as well as countries in Africa, it is hard to overstate the impact that this is having.”

Regulatory hurdles have also set Novavax back. On Monday, company executives said that a now-resolved issue with an “assay” — a test that was needed to confirm that their product can be consistently manufactured at commercial scale across multiple production plants — was delaying regulatory approvals around the world, and that countries like Britain and the United States would not grant authorization until at least July. Company officials once said they hoped to gain authorization for their vaccine in April.

persuaded Novavax to set up a trial there last year in part by promising speed in clinical development and regulatory approval. But time is running out: About two-thirds of British adults have received a first dose of a coronavirus vaccine, most made by AstraZeneca, and every adult is expected to be offered one by the end of July.

The vaccine’s role in Britain depends in part on how quickly Novavax can start distributing its shot. A British factory making the vaccines has said that it would be ready by the summer. The country has recently turned away from the AstraZeneca shot in younger people because of the risk of very rare blood clots, leaving room for Novavax to be an alternative for people under 40.

The country is also studying the effects of administering a second dose of the Novavax vaccine in people who have already received a first dose from either Pfizer or AstraZeneca.

the company was on the verge of closing after a major trial failure for another vaccine, and it was forced to sell off its manufacturing facility to raise money.

Last year, the Trump administration placed a major bet on the tiny company as part of its Operation Warp Speed project, signing a $1.6 billion contract for delivery of 110 million doses by early this year. In April, the total amount of the deal was increased to $1.75 billion, according to Novavax’s financial filings. The company’s large trial in the United States and Mexico has still not been completed, although executives said on Monday that they expected results from that study “in a few weeks.”

Novavax officials said they now did not expect to deliver those doses until the end of this year or early 2022. A spokeswoman for Novavax said there was no penalty for later delivery in its contract with the U.S. government.

Novavax’s spotty track record does not offer confidence that it can rise to the challenge of producing billions of doses, said Les Funtleyder, a health care portfolio manager at E Squared Capital Management who invests in domestic and emerging markets. “It seems they were really unprepared for a challenge of this magnitude,” he said.

Recent news of internal turnover — such as the departure last month of Novavax’s chief financial officer, five months after taking the role, for personal reasons — does not help, Mr. Funtleyder said. “It’s a bad look,” he said.

children older than 12, in an effort to catch up to Moderna and Pfizer, which have already tested their products in that age group.

The vaccine can also be stored at normal refrigeration temperatures, without the freezing temperatures required by Pfizer and Moderna’s vaccines.

“By the end of 2021 there will still be a great need for safe and effective vaccines that can travel well,” said Ms. Taylor, of Duke University. “Novavax looks like it can fit that description.”

Dr. Saad B. Omer, the director of the Yale Institute for Global Health, noted that when concerns were raised over the Johnson & Johnson and AstraZeneca vaccines because of links to blood clots, countries with multiple vaccines available were able to switch to other options.

“It’s good to hedge our bets,” he said. “If we want to avoid, for example, body blow after body blow to low-income countries in many parts of the world that has an impact on everyone, we need to vaccinate a huge chunk of the world.”

Benjamin Mueller and Noah Weiland contributed reporting.

View Source

India’s Serum Institute Struggled to Meet Its Covid-19 Vows

NEW DELHI — Adar Poonawalla made big promises. The 40-year-old chief of the world’s largest vaccine maker pledged to take a leading role in the global effort to inoculate the poor against Covid-19. His India-based empire signed deals worth hundreds of millions of dollars to make and export doses to suffering countries.

Those promises have fallen apart. India, engulfed in a coronavirus second wave, is laying claim to his vaccines. Other countries and aid groups are now racing to find scarce doses elsewhere.

At home, politicians and the public have castigated Mr. Poonawalla and his company, the Serum Institute of India, for raising prices mid-pandemic. Serum has suffered production problems that have kept it from expanding output at a time when India needs every dose. He has come under criticism for departing to London amid the crisis, though he said it was only a quick trip. He told a British newspaper he had received threats from politicians and some of India’s “most powerful men,” demanding that he supply them with vaccines. When he returns to India, he will travel with government-assigned armed guards.

In an interview with The New York Times, Mr. Poonawalla defended his company and its ambitions. He had no choice but to hand over vaccines to the government, he said. He cited a lack of raw materials, which he has partially blamed on the United States. Making vaccines, he said, is a painstaking process that requires investment and major risks. He said he would return to India when he had finished his business in London. He shrugged off his earlier comments about threats, saying they were “nothing we can’t handle.”

backed waiving intellectual property protections for vaccines, which could make it easier for Indian factories to make them. Still, that won’t help India’s current crisis, which as of Friday had claimed more than 230,000 lives — a figure that likely represents a vast undercount.

a horse breeder turned vaccine billionaire. Before the crisis, he was extolled in the Indian media as an example of a new class of young, worldly entrepreneurs. Photos of him and his wife, Natasha, were a staple of fashion spreads.

Serum received a $300 million grant from the Gates Foundation to supply as many as 200 million doses of Covishield and another vaccine in development to the Gavi Alliance, the public-private partnership that is overseeing Covax, the program to donate vaccines to poor countries.

Serum pledged between January and March to sell about 1.1 billion vaccine doses in coming months, according to a review of purchase agreements supplied by UNICEF. By the time India largely stopped vaccine exports, Serum had exported only about 60 million doses, about half to Gavi. India had claimed more than 120 million.

AstraZeneca has served Serum a legal notice over delivery delays. Serum has just “temporarily deferred” its commitments, Mr. Poonawalla said, citing the Indian government’s halt of exports.

“This is something coming from India,” he said. “It’s not the supplier that is defaulting.”

The world is grappling with the ripple effect. A spokesman for Gavi said that India’s decision to prioritize “domestic needs” is having “a knock-on effect in other parts of the world that desperately need vaccines.” Still, in a sign of the lack of options for getting vaccines, Gavi on Thursday signed a purchase deal with an American vaccine company, called Novavax, involving doses to be made by Serum.

people are being turned away from vaccination centers that have run out of doses.

Serum has missed its expansion targets. Mr. Poonawalla said last fall that by early this year, Serum Institute would be pumping out 100 million doses per month, of which about four in 10 would go overseas.

But after a fire at a facility that was supposed to help the company ramp up vaccine production, Serum’s capacity has remained at about 72 million doses per month. A grant of more than $200 million from the Indian government should help the company reach its goal by summer, he said.

Mr. Poonawalla has also cited raw materials supplies. In April, he asked President Biden on Twitter to “lift the embargo” on raw material used to make Covid-19 vaccines. White House officials said Mr. Poonawalla mischaracterized his situation. Still, the United States said it would send raw materials to the Serum Institute to increase its vaccine production, though Mr. Poonawalla said they haven’t yet arrived.

Mr. Poonawalla has also come under scrutiny for charging different prices to the central government, to India’s states and to private hospitals. Two weeks ago, Serum said it would charge state governments about $5 per dose, about $3 more than what it charges Mr. Modi’s government.

Last week, following criticism, Mr. Poonawalla lowered the price to $4. Still, the critics point to an interview in which Mr. Poonawalla said that he was making a profit even at the central government’s price.

Mr. Poonawalla said that Serum could sell at a lower price to India’s central government because it was ordering larger volumes.

People don’t understand,” Mr. Poonawalla told The New York Times. “They just take things in isolation and then they vilify you, not realizing that this commodity is sold at $20 a dose in the world and we’re providing it for $5 or $6 in India. There’s no end to the cribbing, the complaining, the criticizing.”

includes four to five armed personnel.

In an interview with The Times of London newspaper published last week, he described receiving constant, aggressive calls demanding vaccines immediately. “‘Threats’ is an understatement,” he told the paper.

He played down the threats in his interview with The New York Times, and his office declined to disclose further specifics. Still, the comments caused an uproar in India. Some politicians demanded that he name names.

tweeted that Mr. Poonawalla’s departure to London was “shameful” and that he should reduce prices.

The Serum Institute is planning a major expansion in Britain, investing nearly $335 million for research and development, to fund clinical trials, to build out its sales office and to possibly construct a manufacturing plant, Mr. Poonawalla’s office said.

“Everyone is depending on us to be able to give this magic silver bullet in an almost infinite capacity,” Mr. Poonawalla said. “There’s this tremendous pressure from state governments, ministers, the public, friends, and they all want the vaccine. And I’m just trying to equitably distribute it as best I can.”

Selam Gebrekidan in London and Bhadra Sharma in Kathmandu, Nepal, contributed reporting.

View Source

India’s Covid Vaccinations Fall as Its Outbreak Reaches New Highs

As India recorded a single-day high in new coronavirus cases on Thursday, its vaccination campaign has been marred by shortages and states are competing against one another to get doses, limiting the government’s hope that the country can soon emerge from a devastating outbreak.

The Indian health ministry recorded about 410,000 cases in 24 hours, a new global high, and 3,980 deaths, the highest daily death toll in any country outside the United States. Experts believe the number of actual infections and deaths is much higher.

A second wave of infections exploded last month, and some Indian states reintroduced partial lockdowns, but daily vaccination numbers have fallen. The government said it had administered nearly two million vaccine doses on Thursday, far lower than the 3.5 million doses a day it reached in March. Over the past week, 1.6 million people on average were vaccinated daily in the country of 1.4 billion.

India’s pace of vaccinations has become a source of global concern as its outbreak devastates the nation and spreads into neighboring countries, and as a variant first identified there begins to be found around the world. The outbreak has prompted India to keep vaccine doses produced by its large drug manufacturing industry at home instead of exporting them, slowing down vaccination campaigns elsewhere.

delay the expansion of vaccine access to younger age groups because of shortages.

India also lacks enough doses to meet the growing demand. Two domestic drug companies — the Serum Institute of India, which is manufacturing the vaccine developed by AstraZeneca, and Bharat Biotech, which is making its own vaccine — are producing fewer than 100 million doses per month.

About 3 percent of India’s population has been fully vaccinated, and 9.2 percent of people have received at least one dose. Experts say that at the current rate the country is unlikely to meet Prime Minister Narendra Modi’s target of inoculating 300 million people by August.

India has recorded 20.6 million coronavirus cases and more than 226,000 deaths, according to a New York Times database.

India’s government has said it will fast-track approvals of foreign-made vaccines, and on Wednesday the Biden administration said it would support waiving intellectual property protections for Covid-19 vaccines to increase supplies for lower-income countries.

approved the departure of family members of U.S. government employees in India and is urging American citizens to take advantage of commercial flights out of the country. It said on Wednesday that it would approve the voluntary departure of nonemergency U.S. government employees.

On Thursday, Sri Lanka became the latest country to bar travelers from India, joining the United States, Britain, Australia and others.

View Source

As the Virus Ravages Poorer Countries, Rich Nations Are Springing Back to Life

Many countries, prepared for the sort of childhood vaccination campaigns they carry out regularly, were startled to find that they could not rely on people simply to show up for a coronavirus vaccine.

“A lot of vaccine hesitancy issues could be addressed, though not all of them overcome, with timely operational funding in place,” said Benjamin Schreiber, the coordinator for Covid-19 vaccines at UNICEF, which is leading Covax delivery efforts.

Amid a race to fund vaccine purchases, though, money for getting them into people’s arms has been overlooked. Of the 92 poorer nations being supplied by Covax, eight have cut their health budgets because of virus-related economic losses, and several others are struggling to fund their health systems in part because they do not qualify for grants or more generous loans, Mr. Schreiber said.

The World Bank has promised $12 billion for vaccine rollouts, but has so far approved $2 billion in projects. In mid-March, the bank found that less than a third of low- and middle-income nations reported having plans to train enough vaccinators or campaigns in place to fight vaccine hesitancy, said Mamta Murthi, the bank’s vice president for human development.

Many countries’ needs are even simpler. Some cannot pay to print immunization cards. Malawi, which is planning to destroy 16,000 doses that arrived only shortly before they expired, has struggled to cover lunch allowances for health workers traveling from one facility to another to give vaccines.

The outlook is uncertain. More doses will breed more vaccine confidence, said Freddy Nkosi, the country director in the Democratic Republic of Congo for VillageReach, a health nonprofit. But if India’s outbreak keeps surging, the chief executive of the Serum Institute of India said recently, “We are going to have to keep supplying to India, and not anywhere else.”

View Source

Vacunar a todo el mundo no es fácil. Esta es la razón

Más de 600 millones de personas en todo el mundo han sido vacunadas, al menos parcialmente, contra la COVID-19, lo que significa que más de 7000 millones aún están sin vacunar. Es un logro sorprendente a la sombra de un reto asombroso.

La mitad de todas las dosis suministradas hasta ahora han ido a parar a los brazos de personas de países donde vive una séptima parte de la población mundial, principalmente Estados Unidos y naciones europeas. Decenas de países, especialmente en África, apenas han comenzado sus campañas de inoculación.

tener todas las cartas en la mano.

Pero gran parte de la cuestión se reduce a la mera logística.

Inmunizar a la mayor parte de la humanidad en poco tiempo es una tarea monumental, nunca antes intentada, y que, según los expertos, el mundo no estaba preparado para afrontar. Señalan que las cosas ya se han movido con una velocidad sin precedentes: hace un año y medio, la enfermedad era desconocida, y las primeras autorizaciones de vacunas ocurrieron hace menos de seis meses.

Pero queda mucho camino por recorrer. He aquí un panorama de las razones del déficit de vacunas.

Sarah Schiffling, experta en cadenas de suministro farmacéutico y ayuda humanitaria de la Universidad John Moores de Liverpool, Gran Bretaña. “Estamos añadiendo esto al otro trabajo. Básicamente estamos duplicando la producción. Las cadenas de suministro de esta magnitud suelen tardar años en llevarse a cabo”.

El mayor fabricante de vacunas del mundo, el Serum Institute de India, fabrica la vacuna para la COVID-19 desarrollada por AstraZeneca y la Universidad de Oxford, y prevé una producción de mil millones de dosis este año, además de los aproximadamente 1500 millones de dosis que fabrica anualmente para otras enfermedades. Pero ha tardado meses en alcanzar ese ritmo.

Con una fuerte inversión de los gobiernos, las empresas han revisado las fábricas, han construido otras nuevas desde cero y han formado a nuevos empleados, un esfuerzo que comenzó el año pasado y que aún está lejos de completarse.

Covax, el esfuerzo global para suministrar vacunas al mundo en desarrollo a bajo costo o de forma gratuita.

Pero algunas de las promesas aún no se han cumplido. Y, en cualquier caso, suponen una pequeña fracción de lo que las naciones ricas han gastado en sí mismas, y una pequeña fracción de la necesidad mundial.

La campaña Covax también perdió algo de terreno cuando surgió la preocupación de que la inyección de AstraZeneca —que se esperaba que fuera la columna vertebral del esfuerzo— podría estar relacionada con efectos secundarios muy raros pero graves. Esto provocó cierta desconfianza en el público respecto a su uso.

compartir sus propios procesos patentados con el resto del mundo. Ningún productor de vacunas lo ha hecho voluntariamente, y ningún gobierno ha indicado que vaya a avanzar en esa dirección.

Dada la limitada capacidad de producción del mundo, y lo recientes que son estas vacunas, es posible que compartir las patentes no aumente significativamente la oferta en este momento. Pero más adelante, a medida que la capacidad se amplíe, podría convertirse en un factor importante.

La gestión de Joe Biden anunció apoyo financiero a una empresa india, Biological E, para que aumente la producción en masa de la vacuna de Johnson & Johnson destinada a personas de otras partes del mundo. Y el gobierno dijo esta semana que enviaría hasta 60 millones de dosis de la vacuna de AstraZeneca —que Estados Unidos compró, pero no está usando— a otros países.

Pero Estados Unidos sigue muy por detrás de China y Rusia en este tipo de “diplomacia de las vacunas”.

covid hace estragos en ese país a una escala que no se ha visto en ningún otro sitio. El propio gobierno de India ha prohibido las exportaciones de vacunas, lo que obstaculiza los esfuerzos de inmunización en África.

La semana pasada, el gobierno de Biden dijo que relajaría los controles de exportación para India.

controla una patente crucial sobre un proceso utilizado en la fabricación de vacunas, y sus Institutos Nacionales de Salud ayudaron a desarrollar la vacuna de Moderna.

Todo ello da a los gobiernos un enorme poder para obligar a las empresas a trabajar más allá de las fronteras, tanto corporativas como nacionales, pero se han mostrado reacios a utilizarlo. En Estados Unidos, esto ha empezado a cambiar desde que el presidente Biden asumió el cargo en enero.

“El gobierno tiene una enorme influencia, en particular sobre Moderna”, dijo Tinglong Dai, profesor asociado de la escuela de negocios de la Universidad Johns Hopkins, especializado en gestión de la salud.

Las patentes son un área en la que los gobiernos podrían ser más agresivos a la hora de utilizar su influencia. Pero a corto plazo, dijo Dai, lo que habría tenido un mayor impacto es que los funcionarios hubieran actuado antes y con más fuerza para insistir en que las empresas que desarrollan vacunas lleguen a acuerdos con sus competidores para aumentar la producción en masa.

Ese tipo de cooperación ha resultado ser esencial.

Varias empresas indias aceptaron fabricar la vacuna rusa Sputnik. Sanofi, que ya participa en la producción de las inoculaciones de Pfizer-BioNTech y Johnson & Johnson, llegó recientemente a un acuerdo con Moderna para trabajar también en su vacuna. Moderna ya tenía acuerdos con otras tres empresas europeas.

El gobierno de Biden presionó a Johnson & Johnson para que en marzo reclutara a su competidor, Merck, para producir su vacuna, y el gobierno se comprometió a destinar 105 millones de dólares para acondicionar una planta de Merck en Carolina del Norte con ese fin.

El expresidente Donald Trump se negó a invocar la Ley de Producción de Defensa para dar a los fabricantes de vacunas un acceso preferente a los materiales que necesitaban, un paso que Biden ha dado.

AstraZeneca como Johnson & Johnson, dos de las mayores empresas farmacéuticas del mundo, se encontraron con graves problemas de producción con sus vacunas para la COVID-19, lo que supone una lección de los retos que supone pasar de la nada a cientos de millones de dosis.

Además, las vacunas de Pfizer-BioNTech y Moderna se basan en un fragmento del código genético del coronavirus llamado ARN mensajero o ARNm. Hasta el año pasado, este proceso nunca se había utilizado en una vacuna de producción masiva. Requiere equipos, materiales, técnicas y conocimientos diferentes a los de las vacunas estándar.

Las vacunas de ARNm encierran el material genético en “nanopartículas lipídicas”, burbujas microscópicas de grasa. Pocas instalaciones en el mundo tienen experiencia en la producción en masa de algo comparable. Las vacunas también requieren temperaturas ultrafrías, lo que, según los expertos, limita su uso —al menos por ahora— a los países más ricos.

Muchas empresas farmacéuticas insisten en que podrían asumir esa producción, pero los expertos afirman que probablemente necesitarían mucho tiempo e inversión para prepararse, algo que Stéphane Bancel, director ejecutivo de Moderna, señaló en febrero en una audiencia del Parlamento Europeo.

Incluso contratando a empresas muy avanzadas para hacer el trabajo, dijo Bancel, Moderna tuvo que pasar meses esencialmente desbaratando sus instalaciones, reconstruyéndolas según las nuevas especificaciones con nuevos equipos, probando y volviendo a probar ese equipo y enseñando a la gente el proceso.

@perezpena • Facebook

View Source

What Would It Take to Vaccinate the Whole World? Let’s Take a Look.

More than 600 million people worldwide have been at least partially vaccinated against Covid-19 — meaning that more than seven billion still have not. It is a striking achievement in the shadow of a staggering challenge.

Half of all the doses delivered so far have gone into the arms of people in countries with one-seventh of the world’s people, primarily the United States and European nations. Dozens of countries, particularly in Africa, have barely started their inoculation campaigns.

As wealthy countries envision the pandemic retreating within months — while poorer ones face the prospect of years of suffering — frustration has people around the world asking why more vaccine isn’t available.

Nationalism and government actions do much to help explain the stark inequity between the world’s haves and have-nots. So, for that matter, does government inaction. And the power of the pharmaceutical companies, which at times seem to hold all the cards, cannot be ignored.

said Sarah Schiffling, an expert on pharmaceutical supply chains and humanitarian relief at Liverpool John Moores University in Britain. “We’re adding this on top. We’re basically doubling output. Supply chains of this magnitude usually take years to accomplish.”

Covax, the global effort to supply vaccines to the developing world at little or no cost.

But some of the pledges have not been fulfilled as yet. And in any case they amount to a small fraction of what the wealthy nations have spent on themselves, and a small fraction of the global need.

The Covax campaign also lost some ground when concerns emerged that the AstraZeneca shot — which was expected to be the backbone of the effort — might be tied to very rare but serious side effects. That led to some public wariness over using it.

Many public health advocates have called for Western governments to force drug makers to share their own patented processes with the rest of the world. No vaccine producer has done so voluntarily, and no government has indicated that it will move in that direction.

mass production of the Johnson & Johnson shot for people in other parts of the world. And the administration said this week that it would send up to 60 million doses of AstraZeneca’s vaccine — which the United States has bought but isn’t using — to other countries.

But the United States remains well behind China and Russia in such “vaccine diplomacy.”

The United States and other countries have also restricted exports of some vaccine-making materials, drawing intense criticism, especially from India, as Covid ravages that country on a scale not seen anywhere else. India’s own government has barred exports of finished vaccines, hampering immunization efforts in Africa.

This past week, the Biden administration said it would relax export controls for India.

controls a crucial patent on a process used in vaccine making, and its National Institutes of Health helped develop the Moderna vaccine.

All of that gives governments tremendous power to compel companies to work across boundaries, corporate as well as national, but they have been reluctant to use it. In the United States, that has started to change since President Biden took office in January.

“The government has huge leverage, the most over Moderna,” said Tinglong Dai, an associate professor at Johns Hopkins University’s business school who specializes in health care management.

AstraZeneca and Johnson & Johnson, two of the world’s largest pharmaceutical companies, have run into serious production problems with their Covid-19 vaccines — object lessons in the challenges of scaling up in a hurry from nothing to hundreds of millions of doses.

that process had never been used in a mass-produced vaccine. It calls for different equipment, materials, techniques and expertise than standard vaccines.

The mRNA vaccines encase the genetic material in “lipid nanoparticles,” microscopic bubbles of fat. Few facilities in the world have any experience mass-producing anything comparable. The vaccines also require ultracold temperatures, which experts say limits their use — at least for now — to wealthier countries.

Many pharmaceutical companies insist that they could take on that production, but experts say they would be likely to need considerable time and investment to prepare, a point that Stéphane Bancel, chief executive of Moderna, made in February at a European Parliament hearing.

Even in contracting with highly advanced firms to do the work, Mr. Bancel said, Moderna had to spend months essentially gutting facilities, rebuilding them to new specifications with new equipment, testing and retesting that gear and teaching people the process.

“You cannot go to a company and have them start right away to make mRNA product,” he said.

View Source