Moderna refused China request to reveal vaccine technology

 Moderna has refused to hand over to China the core intellectual property behind the development of its breakthrough Covid-19 vaccine, leading to a collapse in negotiations on its sale there, according to multiple people familiar with the matter. 

Sun Yu in New York, Eleanor Olcott in Hong Kong and Donato Paolo Mancini in London OCTOBER 2 2022 

The mRNA vaccine technology used by Moderna provides longer-lasting and higher levels of protection than tech used by Chinese providers © FT montage: AFP/Getty Images

 Moderna has refused to hand over to China the core intellectual property behind the development of its breakthrough Covid-19 vaccine, leading to a collapse in negotiations on its sale there, according to multiple people familiar with the matter. 

 The Massachusetts-based pharmaceutical company turned down Beijing’s request to hand over the recipe for its messenger RNA vaccine because of commercial and safety concerns, said two people involved in negotiations that took place between 2020 and 2021. 

The vaccine maker says it is still “eager” to sell the product to China. The mRNA vaccine technology used by Moderna and BioNTech/Pfizer provides longer-lasting and higher levels of protection than the inactivated vaccine technology used by Chinese makers. 

Several Chinese pharma companies are racing to develop a homemade mRNA alternative but have struggled with the emergence of more infectious variants. 

 One individual close to the Moderna team in Greater China said the company had “given up” on its previous efforts to access the Chinese market, because of Beijing’s demand that it hand over the technology as a prerequisite for selling into the country. 

 To date, Beijing has offered two routes for foreign Covid-19 vaccine makers to distribute in China, dependent on regulatory approval: carrying out a full technology transfer to a domestic drugmaker or establishing a manufacturing facility in China with a local partner, while keeping control of the underlying technology. 

Moderna was pressed to take the former option. 

 The German group BioNTech has struck a deal with Shanghai Fosun Pharmaceutical to conduct clinical trials and commercialise its vaccine in 2020, which meant it retained control of the intellectual property. 

Under the partnership, Fosun agreed to provide a factory that would make up to 1bn doses a year. 

 By contrast, the Shanghai-based Everest Medicines group made a deal to access the Canadian biotech company Providence Therapeutics’s mRNA vaccine candidate that involved a full tech transfer. 

 Beijing has not granted either vaccine regulatory approval. 

 The Moderna leadership did not want to hand over the vaccine recipe to a Chinese partner because of the reputational damage if the local partner botched the manufacturing, said two people with knowledge of the matter. 

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 Moderna has been fiercely protective of its intellectual property around the world, saying handing over patents would do little to address supply constraints. Talks in Italy for a tech transfer to local manufacturing sites have also failed, but Moderna gave the reason that it lacked the capacity to oversee it. 

 China has not approved any mRNA products for therapeutic purposes, and the mass production of this kind of vaccine is more complex than China’s existing inactivated vaccines made by Sinopharm and Sinovac. 

 In recent weeks, Moderna has signalled a willingness to restart talks with China. Its chief medical officer Paul Burton said this month: “We would certainly be very eager to collaborate with China if they felt that there was a need for a vaccine there.” 

 Burton’s comments came days after US president Joe Biden proclaimed the “pandemic is over”, wiping more than $10bn off the market value of the main makers of vaccines, including Moderna. 

 Moderna told the Financial Times: “We are not currently engaged in supply talks with China. We are open to speaking with countries on their supply needs for Covid-19 vaccines.” 

 Industry insiders observed that the company’s willingness to reopen talks with China, the last remaining major economy without an mRNA jab, has been driven by sluggish demand for vaccines in the wealthier countries where it first targeted sales. 

 According to Airfinity, a data firm that monitors vaccine shipments, Moderna has shipped a greater share of its vaccines to high-income countries than the other three major vaccine makers, a strategy that earned it billions of dollars in profit. 

More than 86 per cent of Moderna’s jabs have been delivered to high-income countries, compared with 74 per cent for BioNTech/Pfizer, 63 per cent for Johnson & Johnson and 19 per cent for AstraZeneca. 

 Slowing demand has afflicted all the major coronavirus vaccine makers, but with the Covid-19 jab its only approved product, the pressure on Moderna’s management is particularly acute, according to people familiar with the matter. 

 Additional reporting by Jamie Smyth in New York

https://www.ft.com/content/a481c129-c5aa-4972-84a8-3a45bb000098

Should you get your booster now or wait until the fall? An expert weighs in

 By Deblina Chakraborty, CNN

Updated 0944 GMT (1744 HKT) July 21, 2022

https://edition.cnn.com/2022/07/21/health/omicron-booster-vaccine-coronavirus-wellness/index.html

(CNN)Covid-19 cases are increasing across the United States once again, driven by the most contagious strain of the coronavirus yet, BA.5. Federal health officials are urging Americans to stay up to date on their vaccines by getting additional boosters if they are due for them, but many people are confused.

Who is eligible for boosters now? Will all adults be able to get a second booster soon? If new boosters are being developed for the fall, should people wait until then or get boosted now? How long should people wait for their booster after having contracted Covid-19? And what about kids — should they get boosters now or wait until school starts?

With BA.5 on the rise, what should event organizers keep in mind? An expert explains

To help us navigate these questions, I spoke with CNN Medical Analyst Dr. Leana Wen, an emergency physician and professor of health policy and management at the George Washington University Milken Institute School of Public Health. She is also author of "Lifelines: A Doctor's Journey in the Fight for Public Health."

CNN: Can you start by reminding us who is eligible for booster doses at this time?

Dr. Leana Wen: The latest guidelines from the US Centers for Disease Control and Prevention are as follows: If you are 50 and above, you are eligible for two booster doses of the mRNA vaccine (Pfizer/BioNTech or Moderna). The first booster dose is given at least five months after your primary vaccination (which is either two doses of the mRNA vaccine or one dose of Johnson & Johnson vaccine). The second booster dose is given at least four months after your first.

If you are between 5 and 49, you are eligible for your first booster dose, if it's been at least five months since your primary series. Children younger than 5 just started receiving their initial vaccinations and therefore are not eligible for additional boosters yet.

There are a couple of exceptions. The first is if you are moderately or severely immunocompromised. Those individuals are generally able to get a third booster dose, with an interval between booster doses that's slightly condensed compared with the intervals for people who aren't immunocompromised. Another exception is for those who received an initial Johnson & Johnson one-dose vaccine, then subsequently got another J&J vaccine as their first booster. Those people, no matter their age, are able to get a second booster of an mRNA vaccine if it has been four months since their second J&J shot.

CNN: Will adults who are under 50 be able to get their second booster anytime soon?

Wen: Federal health officials are discussing expanding the eligibility of second boosters. My best guess is that in the next month or so, they will make at least a permissive recommendation, meaning that those who want to get another booster should be able to receive one.

The decision about who should get a booster and how often is not straightforward. At the end of the day, there is a fundamental disagreement among scientists and public health experts on the purpose of the Covid-19 vaccinations. Some believe that the goal of these vaccines is to prevent severe illness, and as long as the vaccines continue to protect against hospitalization and death, additional boosters aren't needed. Others point to vaccines also being able to reduce symptomatic illness. That effect is not as long-lasting as the protection against severe illness, so those who hold this second point of view would advocate for more frequent boosters. The answer isn't straightforward.

CNN: Are there certain people you'd say really need to get boosted now, if they haven't already?

Wen: Here's how I think about the three groups for whom boosters are more urgent if they have not received them.

A nurse preps a syringe at a pop-up Covid-19 vaccination site at the Albanian Islamic Cultural Center, April 8, 2021, in the New York borough of Staten Island.

We know that age is a major risk factor for severe illness, and also that the protection against severe illness wanes in older individuals. People 60 and older, and who are 50 and older with chronic medical conditions, should really receive the two boosters that they are eligible for.

Those who are immunocompromised and are eligible for more boosters should get them, since they, too, are among those who are most vulnerable to severe outcomes from Covid-19.

Beyond that, all adults should receive their first booster. We know that the first booster really increases protection, including against severe disease. If you are 18 and older and have not yet had any vaccines beyond your primary vaccination, you should get your booster now.

CNN: What about children? Should they also get their boosters if they're eligible?

Wen: The data for boosting kids is much less compelling than for adults. The CDC does recommend boosters for children 5 and older, and I think a lot of parents and caregivers will want to follow that guidance. But the urgency is not the same as it would be for adults, especially older adults, who have not yet been vaccinated.

CNN: Let's talk about timing. Some people are worried that if they get vaccinated now, they won't be able to get the Omicron-specific vaccines that may be coming out in the fall. Should that be a reason to wait?

Wen: For most people, I don't think this is a reason to wait. Here's why.

First, federal health officials have said that getting vaccinated now won't preclude you from getting an updated vaccine in the fall. It's worth stating here that it's not certain that these updated vaccines will become available. The one likely to become authorized is the "bivalent" vaccine, meaning that it will be a combination of the original vaccine and an Omicron subvariant vaccine.

Second, there is a lot of virus surging around now. Getting boosted now will protect you now, and if you need an additional level of protection in the fall and winter, you could get another dose then.

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Third, it's not entirely clear that the updated vaccine is going to be better than the vaccines available. The updated vaccine is intended to target the Omicron subvariants, which would be great if the vaccines were currently available, since those are the dominant variants in circulation. However, if they are going to be given in the fall, there is no guarantee that the Omicron subvariants are still going to be the main strains at that point. Of course, we hope that the updated boosters will be more effective than what we have now, but we don't know that's going to be the case — which is even more reason not to wait until then.

CNN: I've heard some people say, I'll wait to get a booster until right before a big trip. Does that make sense?

Wen: I can understand why some people might go with this approach. The booster does enhance protection against infection for a short time period after it's given, probably with maximal effect from about 10 days to three months. Someone who just got boosted could still contract Covid-19, but chances would be lower than if they got the booster, say, six months before.

Of course, there are other ways to reduce your risk of contracting Covid-19, too. If you are very concerned about getting the coronavirus, you should also wear a high-quality N95 or equivalent mask in indoor spaces and avoid crowded settings.

CNN: If someone has just recovered from Covid-19, how long should they wait before their booster?

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Wen: They are able to receive a booster as soon as they are 10 days past when they first started having symptoms and no longer have a fever, though I'd recommend that they wait a bit longer. That's because recent infection conveys good protection for a short period of time and reinfection within a three-month window is rare. To get the longest protection out of your next shot, you could wait three months after your infection to get the additional booster.

https://edition.cnn.com/2022/07/21/health/omicron-booster-vaccine-coronavirus-wellness/index.html

China's Covid-19 vaccine push falters as nations switch to mRNA shots

PUBLISHED  

SEP 30, 2021, 6:33 AM SGT  (This article is 8 mths old)

Many governments that once relied on Chinese shots are now ordering or seeking donations of mRNA vaccines instead. PHOTO: AFP

BEIJING (BLOOMBERG) - In the early days of the Covid-19 vaccine rollout, Chinese shots saved countless lives. They kick-started inoculation programmes across Asia, Latin America and the Middle East, while richer countries hoarded scarce mRNA shots from Pfizer and Moderna.

But many governments that once relied on vaccines from Sinovac Biotech or Sinopharm Group are now turning to options from the United States and Europe instead, as concerns mount about Chinese vaccines' efficacy against the Delta strain and the Western stranglehold on mRNA supplies grows looser.

That preference may already be showing up in China's customs data, where exports of human vaccines dropped 21 per cent in August to US$1.96 billion from US$2.48 billion in July, after rising steadily since December 2020.

"Basically people took what they could get" when Covid-19 vaccines first became available, said Nicholas Thomas, an associate professor at the City University of Hong Kong who has edited several books on foreign policy and public health.

"But as this has gone on, general populations - rather than just medical practitioners - have become more educated about the differences," he said. "They have realised that not all vaccines are equal in terms of protection."

This shift played out during Thailand's deadly outbreak earlier this year. As cases surged and South-east Asia emerged as the new epicentre of the pandemic, the nation desperately tried to purchase vaccines. Only one supplier came through in time: China's Sinovac.

The shots allowed the country of 70 million to begin its inoculation campaign earlier than hoped, but Thailand soon confronted a challenge now faced by lawmakers across the developing world.

The efficacy of China's inactivated vaccines ranges from about 50 per cent to 80 per cent in clinical trials. But they are less potent than mRNA vaccines and questions are mounting about their effectiveness against the highly transmissible Delta variant.

As a result, the Thai government became the first in the world to offer an AstraZeneca shot to people who had already received a jab or even two of Sinovac. While it is not an mRNA, Thai studies showed the Cambridge, UK-based company's viral vector vaccine is potent as a booster to the Chinese shot, and that Pfizer's dose was found to be even more effective.

But many Thais soon expressed a strong preference for Western shots - even protesting to demand them - and the country's opposition began lambasting the government for its reliance on China. Thailand halted orders of Sinovac and began buying more Western vaccines.

I'm not anti-Sinovac," said Chaowat Sittisak, a 29-year-old teacher in northern Thailand who got a first dose of Sinovac but ordered a second Moderna shot from a private hospital. "If the world only had one vaccine and it's Sinovac, I'd get it. But we have so many other choices. And I want whatever is best."

Many governments that once relied on Chinese shots are now ordering or seeking donations of mRNA vaccines instead. The swing away from China is likely to accelerate as US President Joe Biden promises to donate 1.1 billion mRNA shots, Europe pledges hundreds of millions of vaccines and India prepares to once again export AstraZeneca vaccines after curtailing shipments following its deadly second wave.

In addition to availability and efficacy, freedom of movement may also be motivating the shift: Recipients of Chinese vaccines cannot travel to some locations.

Vaccine exports

In a written reply to Bloomberg, Sinovac said its CoronaVac shot has been effective at preventing hospitalisation, intensive care admissions and deaths throughout the pandemic.

A spokesperson said some countries first rolled out Sinovac to the elderly, who are more likely to be hospitalised with Covid-19, while younger populations received different vaccines later, "and this should be factored in the evaluation of CoronaVac's effectiveness".

Many countries, including Thailand, have "purchased vaccines from multiple suppliers in order to maximise the number of doses available for their population," the company said.

As things stand, the list of places shifting away from Chinese vaccines - or augmenting them with Western boosters - includes Turkey and the United Arab Emirates. In China's own territory of Hong Kong, which has long offered residents a choice between BioNTech and Sinovac, health officials are now testing whether the Chinese shot will perform better when paired with a western booster.

While Sinovac allowed Thailand to start its rollout earlier than planned, the 6 million doses arriving in October will be the last shipment. In 2022, at least three quarters of the government's orders will also come from Astra and Pfizer.

Moves like Thailand's represent a blow to China's vaccine diplomacy ambitions. Nevertheless, governments face a tricky balance between wanting to protect the public and maintaining good relations with China.

The Thai Health Ministry has been careful to say that while it has no plans to order more Sinovac, it is not suggesting the shots are not effective. Chinese firms have exported some 884 million doses of its homegrown vaccines via mostly bilateral deals with places like Brazil and Indonesia.

This week, Chile started giving Sinovac shots to children as young as six, a strong endorsement of a shot that's formed the backbone of their rollout.

And there are still many parts of the world drastically short of vaccines. Some African nations, for instance, have barely started their inoculation drives after struggling to procure shots.

Cote d'Ivoire, Burkina Faso and Kenya are all rolling out Chinese vacciness, and Beijing is a key supplier to the World Health Organisation-backed Covax facility aimed at getting vaccines to the developing world. President Xi Jinping has pledged to export 2 billion doses this year, matching commitments by Group of Seven nations.

Various studies conducted around the world have shown the jabs to be effective at preventing serious illness and death. Yet China's pharmaceutical firms - which were initially less forthcoming than western companies in releasing clinical trial data - have not released similarly conclusive studies that inactivated vaccines are effective against the Delta.

Over the coming year, policymakers may well continue turning away from the older technology of the inactivated Chinese vaccines, says Benjamin Cowling, a professor of epidemiology and biostatistics at the University of Hong Kong, who published a recent study in the Lancet showing the Pfizer vaccine generated 10 times more antibodies than Sinovac.

"If you've got some vaccines that are more effective than others, and the cost is roughly the same, then you're going to get a better bang for the buck if you choose the more effective vaccines," Cowling said. "But I still think that the supplies are limited, so it may not be as easy as saying, 'We just want to order the Moderna vaccine,' or whatever."

'Better alternatives'

In Thailand, the opposition Move Forward party is now calling on the government to reveal the percentage of people who have only received the Sinovac shots.

"The government already knows that studies and research show inactivated virus vaccines are less effective against virus mutations when compared to mRNA-based vaccines," said Wiroj Lakkhanaadisorn, an opposition lawmaker and a key critic of the government's vaccine policies. "We should know the vaccination rate that excludes all two-dose Sinovac shots because the immunity may not be enough any more. Any regions that are ready can then reopen."

Thailand's health ministry didn't respond to a request for comment.

Chaowat, the teacher, said he felt pressured to take the Sinovac shot because of his job but is hoping to get a Moderna shot in a month or two.

"The government is turning away from Sinovac because they have to push through with their reopening plan and they want to reduce vaccine hesitancy among people who don't want Sinovac," he said. "They're turning to better alternatives."

Source: https://www.straitstimes.com/asia/east-asia/chinas-covid-19-vaccine-push-falters-as-nations-switch-to-mrna-shots

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Pfizer to sell all its patented drugs at nonprofit price in low-income countries

 

© Reuters. FILE PHOTO: A person walks past a Pfizer logo amid the coronavirus disease (COVID-19) pandemic in the Manhattan borough of New York City, New York, U.S., April 1, 2021. REUTERS/Carlo Allegri/File Photo

Stock Markets1 hour ago (May 25, 2022 08:12)

By Michael Erman

(Reuters) - Pfizer Inc (NYSE:PFE) will make all of its patented medicines including COVID-19 treatment Paxlovid and big-selling breast cancer drug Ibrance available at a not-for-profit price to 45 of the world's poorest countries, the drugmaker said on Wednesday.

These countries lack good access to innovative treatments. It can take four to seven years longer for new treatments to become available in low-income countries, according to the Bill & Melinda Gates Foundation, if they become available at all.

Pfizer said its plan includes 23 wholly-owned, patented medicines and vaccines that treat infectious diseases, certain cancers, and rare and inflammatory diseases. In addition to Paxlovid and Ibrance, the list includes pneumonia vaccine Prevnar 13, rheumatoid arthritis drug Xeljanz and cancer treatments Xalkori and Inlyta.

The COVID-19 vaccine Comirnaty developed with BioNTech SE was also on the list.

Chief Executive Albert Bourla said in an interview that all the medicines being made available should be of use.

"But clearly the antiviral (Paxlovid) is going to be a very big deal for them - if they need it they can get it immediately," he said.

When Pfizer launches new medicines and vaccines, they will also be included in the drug portfolio at a not-for-profit price, it said.

The 27 low-income countries and 18 lower-income countries included in what Pfizer is calling "An Accord for a Healthier World" cover most of Africa and much of Southeast Asia. Five countries - Rwanda, Ghana, Malawi, Senegal and Uganda - have already committed to joining the accord, which was announced at the World Economic Forum in Davos.

Malawi President Lazarus Chakwera said in a statement the accord will allow the countries and the drugmaker to share "the burden of costs and tasks in the production and delivery of supplies that will save millions of lives."

Pfizer has been criticized for how it rolled out its COVID-19 vaccine, with some poorer countries waiting for months after the earliest doses arrived in wealthier countries.

Bourla said the new accord has been informed by the difficulties of that rollout, particularly the lack of health infrastructure in some countries that made distributing the vaccine difficult.

"Instead of washing our hands and saying, 'I gave you the product, do whatever you want with them,' we're saying, 'We'll give you the products and we will sit with you to see how we can help organize a system that can utilize them,'" Bourla said.

Source: 

https://uk.investing.com/news/stock-market-news/pfizer-to-sell-all-its-patented-drugs-at-nonprofit-price-in-lowincome-countries-2656083

China's bet on homegrown mRNA vaccines holds back nation

 TAIPEI, Taiwan (AP) — China is trying to navigate its biggest coronavirus outbreak without a tool it could have adopted many months ago, the kind of vaccines that have proven to offer the best protection against the worst outcomes from COVID-19.

24 May 2022

By HUIZHONG WU and ANIRUDDHA GHOSAL   AP

© Provided by Associated Press China's first SARS-CoV-2 mRNA vaccine AWcorna, developed by Abogen Biosciences, Walvax Biotechnology, and the Academy of Military Medical Sciences' Institute of Biotechnology, is displayed at the National 13th Five-Year Scientific and Technological Innovation Achievement Exhibition in Beijing, China on Oct. 27, 2021. More than two years into the pandemic, China has not approved the more effective mRNA vaccines, instead choosing to pursue its own route on COVID-19 vaccines. (Chinatopix via AP)

As early as the spring of 2020 a Chinese pharmaceutical company, Fosun Pharma, reached an agreement to distribute — and eventually manufacture — the mRNA vaccine made by Pfizer and BioNTech. It still has not been cleared in mainland China, despite being authorized for use by separate authorities in Hong Kong and Macao.

Now health experts say that delay — a result of putting politics and national pride above public health — could lead to avoidable coronavirus deaths and deeper economic losses because whole cities would be locked down to insulate the country’s unprotected population.

“The biggest issue is about the delay of the reopening,” said Xi Chen, a health economist at Yale University’s School of Public Health. “The consequences will be huge, the supply chain disruption, the disruption to all kinds of service sectors.”

Studies have consistently shown that vaccination with mRNA vaccines made by Pfizer-BioNTech and Moderna offer the best protection against hospitalization and death from COVID-19. Chinese vaccines made with older technology proved fairly effective against the original strain of the virus, but much less so against more recent variants.

As this evidence became clearer, even countries that initially used Chinese vaccines and some other less effective Western-made vaccines have turned to mRNA vaccines for booster shots and new vaccinations.

Not China. Regulators have not publicly said why they have not acted — the mRNA vaccines are authorized in much of the world and have proven safe and effective in hundreds of millions of people. But a Chinese health official and another person directly involved in the negotiations told The Associated Press that authorities have held back because they want to master the technology in China and not depend on foreign suppliers. Both spoke on condition of anonymity, given the sensitive nature of the issue.

© Provided by Associated Press Visitors look at giant replica bottles of COVID-19 vaccine including one produced via mRNA technology by Sinopharm subsidiary CNBG at the China International Fair for Trade in Services (CIFTIS) in Beijing, China on Sept. 5, 2021. More than two years into the pandemic, China has not approved the more effective mRNA vaccines, instead choosing to pursue its own route on COVID-19 vaccines. (AP Photo/Ng Han Guan)

For more than a year, the approach seemed defensible. The country was able to keep the virus at bay better than any other large nation with its strict “zero COVID” approach that isolates infected people and locks down communities when infections pop up.

But now, the highly transmissible omicron variant is testing that strategy, requiring ever wider and longer lockdowns that are taking a greater economic and human toll. While other countries are able to operate close to normal because their people are protected by vaccination or previous infection, China is left with only its lockdown strategy to avoid huge numbers of hospitalizations and deaths.

China may be changing its mind. The Communist Party-owned Global Times newspaper reported last month that Fosun Pharma is still working with health authorities on its approval and Shanghai authorities recently issued new policies that could allow the import of COVID-19 vaccines. Fosun, based in Shanghai, did not respond to questions about the announcement.

© Provided by Associated Press Visitors look at giant replica bottles of COVID-19 vaccine including ones produced via mRNA technology by Sinopharm subsidiary CNBG at the China International Fair for Trade in Services (CIFTIS) in Beijing, China on Sept. 5, 2021. More than two years into the pandemic, China has not approved the more effective mRNA vaccines, instead choosing to pursue its own route on COVID-19 vaccines. (AP Photo/Ng Han Guan)

China’s National Health Commission directed questions to the country’s drug regulator, the National Medical Products Administration. That agency did not respond to a faxed request for comment.

In the meantime, hopes for a Chinese-developed mRNA vaccine center on Abogen Biosciences, a startup founded in 2019 by Bo Ying, an American-trained scientist who once worked for Moderna.

The company has partnered with more established companies in the country such as Walvax, a private company founded in 2001, and the Academy of Military Medical Sciences, the military’s medical research facility. Abogen has raised more than $1.7 billion since 2020.

The company’s vaccine candidate succeeded in eliciting an immune response in a small, preliminary test in humans designed to evaluate safety, according to a study published in the journal Lancet Microbe.

The results were “promising,” said Dr. Vineeta Bal, who studies immune systems at the Indian Institute of Science Education and Research in Pune, India, although she said that a direct comparison of the immune response the shot triggered with the Pfizer and Moderna vaccines would have helped scientists better evaluate its performance.

But large studies that are needed to show whether the shot works to prevent infections or symptoms have not been completed. Abogen did not respond to requests for an interview.

Even if the studies can be completed and the vaccine proves effective, manufacturing the millions of doses required will be a challenge, experts say. Abogen built a manufacturing facility in December 2020 with a projected capacity of up to 120 million doses a year.

Manufacturing that vaccine and ensuring quality at scale will be a difficult hurdle to clear because mRNA is still a new technology, said Scott Wheelwright, chief operating officer at BioInno Bioscience, a Chinese biopharmaceutical contract manufacturer who has held conversations with Abogen.

In the meantime, Chen, the Yale health policy expert, said the Chinese government should better protect its elderly population by both approving the Pfizer vaccine and encouraging booster shots.

Using a Chinese phrase that means “giving up completely,” Chen said the change from “zero COVID” does not have to be all or nothing. “It doesn’t have to be tang ping or sticking to zero COVID,” Chen said. “I don’t think there are only two solutions, and we can stick to a middle ground.”

https://apnews.com/article/covid-science-technology-health-00e7e5ebf9460bad115b491009b58bef

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Study: mRNA Vaccines Fare Better Against COVID Variants

 

The research adds to growing evidence that mRNA vaccines—like those made by Pfizer and Moderna—offer the best protection.

By 

Korin Miller

 

 

Published on May 19, 2022

PHOTO: GETTY IMAGES

Fact checked on May 19, 2022 by Vivianna Shields, a journalist and fact-checker.

COVID vaccines that use mRNA technology may provide better protection against WHO-identified variants than viral vector vaccines, new research shows. The findings are in line with what health officials have previously recommended for optimal protection against COVID-19.

The new study, published in PLOS Medicine, sought to compare four vaccines available in the U.S. and U.K.—Pfizer-BioNTech, Moderna, Johnson & Johnson/Janssen, and Oxford-AstraZeneca—and how they perform against five past and present Variants of Concern (Alpha, Beta, Gamma, Delta, and Omicron) identified by the World Health Organization

Although all four vaccines provided protection against severe disease from COVID-19 variants, Pfizer and Moderna's mRNA vaccines provide better overall protection—by way of higher antibody responses after a certain amount of time—than the AstraZeneca and J&J vaccines.

"Based on our results and other current knowledge, vaccination with an mRNA vaccine would, in most cases, lead to a higher immune response and could therefore be preferred," study co-author Jonne Sikkens, MD, PhD, an infectious disease physician at Amsterdam University Medical Centers, told Health.

Here's what to know about the effectiveness of mRNA vaccines on COVID-19 variants, as compared to other available options, and what the research could mean for protection against future virus strains.

mRNA Vaccines Elicit Better Antibody Responses

For the study, researchers from the University of Amsterdam took blood samples from 165 health care workers. For those who took any of the two-dose vaccines (Pfizer, Moderna, and AstraZeneca), samples were taken three and four weeks after the first and second doses, respectively. Blood samples were taken at four to five and eight weeks after vaccination from a single-dose J&J vaccine. Additional samples were taken before and four weeks after a Pfizer booster.

From those samples, researchers measured antibody responses—first, to the original SARS-CoV-2 strain: Samples from participants who received the Moderna vaccine still had the highest antibody responses, followed by samples from Pfizer vaccine participants. Meanwhile, those who received either of the viral vector vaccines had "substantially lower" antibody responses.

A similar scenario played out when testing antibody responses to the variants: neutralizing antibodies were highest following mRNA vaccines as compared to the viral vector vaccines. However, all vaccines still had a reduced ability to neutralize the COVID-19 variants—especially when they were up against Omicron. The Pfizer booster shot was able to substantially improve antibody responses to variants, including Omicron.

Though the findings support previous guidance from the Centers for Disease Control and Prevention (CDC) on choosing mRNA vaccines over other available options, the study still has some limitations. First, the group of participants included more females than males. And regarding the AstraZeneca vaccine specifically, people who received that vaccine were significantly older (in the Netherlands, that vaccine has been restricted to people ages 60 and older), and overall immune responses tend to become weaker with age, study authors said.

More research is also needed to examine the long-term effects of all vaccines on antibody responses, as with other future variants. "Long-term durability of protective effects are still being studied and emergence of new virus variants will lead to a continuously changing situation," said Dr. Sikkens.

 Why the FDA Restricted Use of Johnson & Johnson's COVID-19 Vaccine

Previous Guidance on mRNA vs. Other Vaccines

Recently, public health agencies like the CDC and Food and Drug Administration (FDA) have been urging people to choose mRNA COVID-19 vaccines over the other available option, a J&J vaccine, in the U.S.

In early May, the FDA announced new restrictions on the single-dose J&J vaccine, limiting its use to only people aged 18 or older who are unable or unwilling to receive either mRNA vaccine. Before that, in December 2021, the CDC's Advisory Committee on Immunization Practices preferentially recommended mRNA vaccines; and a few months later in March 2022, the CDC urged people to choose an mRNA booster over an additional J&J shot.

The reasoning for this guidance is twofold: The FDA's restriction of the vaccine is due to an increased risk of a blood clotting issue called thrombosis with thrombocytopenia syndrome (TTS), which has been found to rarely occur following the J&J vaccine. The CDC's urgings also cite the reduced effectiveness of the J&J vaccine as compared to the Pfizer and Moderna options.

Success of mRNA Vaccines Against COVID-19

It's not entirely clear why mRNA vaccines outperform other options, according to study co-author Jonne Sikkens, MD, PhD, an infectious disease physician at Amsterdam University Medical Centers. But researchers have some theories.

The first is simply that the J&J vaccine is a single dose, "which may have limited its effectiveness," Dr. Sikkens told Health, adding that "other research has shown that additional doses of this vaccine increase immune effects."

That other research, as Paul A. Offit, MD, director of the Vaccine Education Center and an attending physician in the Division of Infectious Diseases at Children's Hospital of Philadelphia, points out, shows that a second dose of the J&J vaccine had 94% effectiveness against symptomatic COVID-19 in the U.S.—up from just 66.3% effectiveness from a single dose.

The actual difference in makeup of the vaccines likely plays a role, too, Dr. Sikkens says. The mRNA vaccines encode a portion of the spike protein found on the surface of SARS-CoV-2 to get an immune response, while the viral vector vaccines use an adenovirus which usually causes colds that is modified with the SARS-CoV-2 protein.

Despite the success of mRNA vaccines' antibody responses, its also important to point out that neutralizing antibodies are only one part of immunity. Focusing on only antibody levels "assumes they are a perfect predictor of protection against disease, which isn't true," said Dr. Offit, citing other immunity elements, like memory B cells, which weren't studied in this research. "Neutralizing antibodies can fade to a very low level but you're still protecting against serious illness, which is the goal," said Dr. Offit. "Both types of vaccines meet that goal."

 Can You Get Long COVID If You've Been Vaccinated?

mRNA Vaccines and Protection Against Future Variants

The current research only looks at the antibody responses of vaccines to variants that have already been identified. While it's difficult to say what will happen with future variants, the work here suggests an mRNA booster may be important for maximum protection. "A subsequent boost with an mRNA vaccine can lead to high immune responses against current variants, even against the first Omicron virus type," said Dr. Sikkens.

But a change to the current mRNA vaccines may be even more beneficial. "The Omicron virus has been evolving and several current and future Omicron subtypes may very well be less susceptible to the vaccination-induced immunity of the current vaccines," continued Dr. Sikkens. "Evolvement of current vaccines to incorporate a response specific for these new virus types is becoming more and more important."

For now—until a new or updated vaccine is able to offer more protection against future variants—it's important to keep in mind that, regardless of the vaccine you received, immunization practices are still doing what they were designed to do. "We've confused people about what it means to be fully vaccinated and what matters," said Dr. Offit. "The goal is to protect against serious illness."

The information in this story is accurate as of press time. However, as the situation surrounding COVID-19 continues to evolve, it's possible that some data have changed since publication. While Health is trying to keep our stories as up-to-date as possible, we also encourage readers to stay informed on news and recommendations for their own communities by using the CDC, WHO, and their local public health department as resources.

Source:

https://www.health.com/news/mrna-vaccines-covid-variants

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