Suspicions grow that nanoparticles in Pfizer’s COVID-19 vaccine trigger rare allergic reactions

‘Severe allergy-like reactions in at least eight people who received the COVID-19 vaccine produced by Pfizer and BioNTech over the past 2 weeks may be due to a compound in the packaging of the messenger RNA (mRNA) that forms the vaccine’s main ingredient, scientists say. A similar mRNA vaccine developed by Moderna, which was authorized for emergency use in the United States on Friday, also contains the compound, polyethylene glycol (PEG).

‘PEG has never been used before in an approved vaccine, but it is found in many drugs that have occasionally triggered anaphylaxis—a potentially life-threatening reaction that can cause rashes, a plummeting blood pressure, shortness of breath, and a fast heartbeat. Some allergists and immunologists believe a small number of people previously exposed to PEG may have high levels of antibodies against PEG, putting them at risk of an anaphylactic reaction to the vaccine.’

Read here (Science magazine, Dec 21, 2020)

Whose liability for Pfizer’s vaccine?

‘The well-known The Independent newspaper reports that the United Kingdom Department of Health and Social Care has confirmed that Pfizer required, and has been given, an indemnity by the government, protecting it from legal action if any ill-effects arise from the dispensation of the vaccine.

‘What does this mean? What is the effect in law of such an indemnity? Simply, that the country that provides the indemnity becomes primarily and independently liable if anything goes wrong with the uptake of the vaccine.’

Read here (The Sun Daily, Dec 14, 2020)

Information for UK recipients on Pfizer/BioNTech COVID-19 vaccine: UK government

‘Warnings and precautions: Talk to your doctor, pharmacist or nurse before you are given the vaccine if you have:

• Had a serious allergic reaction to a previous vaccine, medicine or food
• Had any problems following previous administration of COVID-19 mRNA Vaccine BNT162b2 such as allergic reaction or breathing problems
• A severe illness with high fever. However, a mild fever or upper airway infection, like a cold, are not reasons to delay vaccination.
• A weakened immune system, such as due to HIV infection, or are on a medicine that affects your immune system
• A bleeding problem, bruise easily or use a medicine to inhibit blood clotting

‘As with any vaccine, COVID-19 mRNA Vaccine BNT162b2 may not fully protect all those who receive it. No data are currently available in individuals with a weakened immune system or who are taking chronic treatment that suppresses or prevents immune responses.

‘Other medicines and COVID-19 mRNA Vaccine BNT162b2: Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines or have recently received any other vaccine.

‘Pregnancy and breast-feeding: There is currently limited data available on the use of this vaccine in pregnant women. If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before you receive this vaccine. As a precaution, you should avoid becoming pregnant until at least 2 months after the vaccine.’

Click here to read more (UK government, Dec 2020)

People with a history of ‘significant’ allergic reactions shouldn’t have Pfizer jab, UK regulator warns

‘The UK’s Medicines and Healthcare products Regulatory Agency updated its guidance to British health service trusts on who should receive the vaccine. The precautionary advice came after two members of Britain’s National Health Service, who received the vaccine on Tuesday, experienced allergic reactions to the shot. Both are recovering well, according to the national medical director for the NHS.’

Read here (CNBC, Dec 9, 2020)

Public needs to prep for vaccine side effects

‘This summer, computational biologist Luke Hutchison volunteered for a trial of Moderna's COVID-19 vaccine. But after the second injection, his arm swelled up to the size of a “goose egg,” Hutchison says. He can't be sure he got the vaccine and not a placebo, but within a few hours, Hutchison, who was healthy and 43, was beset by bone and muscle aches and a 38.9°C fever. “I started shaking. I had cold and hot rushes,” he says. “I was sitting by the phone all night long thinking: ‘Should I call 911?’”

‘Hutchison's symptoms resolved after 12 hours. But, he says, “Nobody prepared me for the severity of this.” He says the public should be better prepared than he was, because a subset of people may face intense, if transient, side effects, called reactogenicity, from Moderna's vaccine. Some health experts agree.’

Read here (Science, Nov 27, 2020) 

Moderna's chief medical officer says that vaccine trial results only show that they prevent people from getting sick — not necessarily that recipients won't still be able to transmit the virus

‘Moderna Chief Medical Officer Tal Zaks told Axios that the public should not "over-interpret" the vaccine trial results to assume life could go back to normal after adults are vaccinated. "They do not show that they prevent you from potentially carrying this virus transiently and infecting others," Zaks told Axios.  While he believes, based on the science, that it's likely that vaccine does prevent transmission, but said there's still no solid proof of that yet. "I think it's important that we don't change behavior solely on the basis of vaccination," he said.’

Read here (Business Insider, Nov 24, 2020)

Coronavirus vaccines face trust gap in Black and Latino communities, study finds

‘If offered a coronavirus vaccine free of charge, fewer than half of Black people and 66 percent of Latino people said they would definitely or probably take it, according to a survey-based study that underscores the challenge of getting vaccines to communities hit hard by the pandemic... Perhaps its most sobering findings: 14 percent of Black people trust that a vaccine will be safe, and 18 percent trust that it will be effective in shielding them from the coronavirus. Among Latinos, 34 percent trust its safety, and 40 percent trust its effectiveness.’

Read here (Washington Post, Nov 23, 2020)

Doctors say CDC should warn people the side effects from Covid vaccine shots won’t be ‘a walk in the park’

‘The CDC must be transparent about the side effects people may experience after getting their first shot of a coronavirus vaccine, doctors urged during a meeting Monday with CDC advisors. Dr. Sandra Fryhofer said that both Pfizer’s and Moderna’s Covid-19 vaccines require two doses and she worries whether her patients will come back for a second dose because of potentially unpleasant side effects after the first shot. Both companies acknowledged that their vaccines could induce side effects that are similar to symptoms associated with mild Covid-19, such as muscle pain, chills and headache.’

Read here (CNBC, Nov 23, 2020)

India tops global survey on Covid-19 vaccination intent; rising hesitancy in many other countries

‘Indians are the keenest on getting vaccinated whenever a Covid-19 vaccine is available, even as people in 10 out of 15 countries showed a growing reluctance about getting vaccinated, according to a global survey. 

‘In the World Economic Forum/Ipsos survey of 18,526 adults from 15 countries, 73 per cent said they would get a Covid-19 vaccine if available, down from 77 per cent in August. While vaccination intent has remained unchanged at 87 per cent in India since August, it has declined in 10 of the 15 countries surveyed, most of all in China, Australia, Spain, and Brazil.

‘Globally, the two main reasons for not wanting to get a Covid-19 vaccine are concerns about side effects (cited by 34 per cent) and concerns about clinical trials moving too fast (cited by another 33 per cent). In India also, 34 per cent respondents.’

Read here (Deccan Herald, Nov 6, 2020)

NIH ‘very concerned’ about serious side effect in coronavirus vaccine trial​

‘A great deal of uncertainty remains about what happened to the unnamed patient, to the frustration of those avidly following the progress of vaccine testing. AstraZeneca, which is running the global trial of the vaccine it produced with Oxford University, said the trial volunteer recovered from a severe inflammation of the spinal cord and is no longer hospitalized.

‘AstraZeneca has not confirmed that the patient was afflicted with transverse myelitis, but Nath and another neurologist said they understood this to be the case. Transverse myelitis produces a set of symptoms involving inflammation along the spinal cord that can cause pain, muscle weakness and paralysis. Britain’s regulatory body, the Medicines and Healthcare Products Regulatory Agency, reviewed the case and has allowed the trial to resume in the United Kingdom.’

Read here (Scientific American, Sept 15, 2020)

How the race for a Covid-19 vaccine is getting dirty

‘Political pressure has been mounting for scientists to deliver an economy-saving result, and reports of corner-cutting emerge daily... Nor is it just politicians who are in a hurry. On 2 August, Steven Salzberg, a computational biologist at Johns Hopkins University in Baltimore, Maryland, suggested in Forbes magazine that a promising vaccine be rolled out to a wider pool of volunteers before clinical trials had been completed, triggering an outcry (and some sympathy) that prompted him to recant the next day. Meanwhile, a research group with links to Harvard University continues to defend its publication in July of a recipe for a DIY Covid-19 vaccine – one that only the group’s 20-odd members had previously tested.’ 

Read here (The Guardian, August 30, 2020)

Why is the ‘anti-vaxxer’ movement growing during a pandemic?

 The worldwide rush to rollout the Covid-19 vaccine has created a large group of “vaccine hesitant” people -- over and above the hardcore anti-vaxxers. “Anti-vaccination sentiment is going into the mainstream,” says Heidi Larson, director of the Vaccine Confidence Project at the London School of Hygiene and Tropical Medicine. “A lot of people you never would have imagined are now saying that maybe the anti-vaccination lobby has a point.”

‘Concerns about vaccinations vary from country to country, but they are often held by people not normally associated with fringe views or conspiracy theories. Many are highly educated, and they are just as likely to be liberal as conservative. “If you want to map where the anti-vaccination movement is strongest, just look for your nearest Whole Foods,” says Barry Bloom, a professor of public health at Harvard University, referring to the high-end supermarket chain.’

Read here (Financial Times, August 20, 2020)

Top US infectious disease expert Fauci urges caution on China and Russia Covid-19 vaccines

‘America’s top infectious diseases official has raised concerns over the safety of Covid-19 vaccines being developed by China and Russia as the world scrambles for answers to a pandemic the WHO warned will be felt for decades. Several Chinese companies are at the forefront of the race to develop an immunity to the disease and Russia has set a target date of September to roll out its own vaccine. But US infectious disease expert Anthony Fauci said it was unlikely his country would use any vaccine developed in either country, where regulatory systems are far more opaque than they are in the West.’

Read here (Straits Times, August 3, 2020)

Covid-19 vaccines may cause mild side effects, experts say, stressing need for education, not alarm

‘While the world awaits the results of large clinical trials of Covid-19 vaccines, experts say the data so far suggest one important possibility: The vaccines may carry a bit of a kick. In vaccine parlance, they appear to be “reactogenic,” meaning they have induced short-term discomfort in a percentage of the people who have received them in clinical trials. This kind of discomfort includes headache, sore arms, fatigue, chills, and fever.

‘At least two manufacturers, Cambridge, Mass.-based Moderna and CanSino, a Chinese vaccine maker, stopped testing the highest doses of their Covid-19 vaccines because of the number of severe adverse events recorded among participants in their clinical trials.’

Read here (STAT, July 27, 2020)

Merck CEO Ken Frazier discusses a Covid cure, racism, and why leaders need to walk the talk

‘As chairman and CEO of the leading vaccine producer in the world, pharmaceutical giant Merck & Co., Ken Frazier has one of the highest-profile positions in global business.

‘But Frazier, who is leading one of the firms on a charge to develop a COVID-19 vaccine, is unique in another way: He is just one of four Black CEOs leading a Fortune 500 company. Frazier is also outspoken, having resigned from President Trump’s American Manufacturing Council to make a clear statement against “hatred, bigotry and group supremacy” that surfaced in protests at Charlottesville, Virginia.

‘In the video [with transcript] below, Frazier provides insights into this turbulent period of American history with Tsedal Neeley (@tsedal), the Naylor Fitzhugh Professor of Business Administration at Harvard Business School. Topics ranged from corporate America’s role in hiring more African Americans to the experience of being raised just one generation away from slavery.’

View/read here (Harvard Business School, July 13, 2020)