Covid-19 vaccines don't raise miscarriage risk, three studies show

Pregnant women who received at least one dose of a COVID-19 vaccine were not at higher risk for miscarriage than their unvaccinated counterparts, according to a trio of new US studies:

Miscarriage no more likely in vaccinated: In the first study, published yesterday in JAMA, researchers from the Vaccine Safety Datalink (VSD) surveillance network used diagnostic and procedure codes and electronic health records to identify and assign gestational ages of miscarriages and ongoing pregnancies from Dec 15, 2020, to Jun 28, 2021... Read here.

More evidence of vaccine safety in pregnancy: Similarly, in a letter yesterday in the New England Journal of Medicine (NEJM), CDC scientists enrolled 2,456 women who were part of the agency's COVID-19 vaccine safety pregnancy registry... Read here.

A revised risk estimate: And in response to a letter yesterday in NEJM, a separate group of CDC researchers updated its analysis of 2,456 pregnant women who received one or two doses of an mRNA COVID-19 vaccine before conception or 20 weeks' gestation... Read here.

Read here (Center for Infectious Disease Research and Policy, Sept 9, 2021)

Vaccination reduces risk of long Covid, even when people are infected, UK study indicates

‘People who are fully vaccinated against Covid-19 appear to have a much lower likelihood of developing long Covid than unvaccinated people even when they contract the coronavirus, a study published Wednesday indicated. The research is among the earliest evidence that immunization substantially decreases the risk of long Covid even when a breakthrough infection occurs. Already, researchers had said that by preventing many infections entirely, vaccines would reduce the number of cases of long Covid, but it wasn’t clear what the risk would be for people who still got infected after vaccination.’

Read here (STAT, Sept 1, 2021)

The blood-clot problem is multiplying

‘Whether the blood issues are ultimately linked to only one vaccine, or two vaccines, or more, it’s absolutely crucial to remember the unrelenting death toll from the coronavirus itself—and the fact that COVID-19 can set off its own chaos in the circulatory system, with blood clots showing up in “almost every organ.” That effect of the disease is just one of many reasons the European Medicines Agency has emphasized that the “overall benefits of the [AstraZeneca] vaccine in preventing COVID-19 outweigh the risks of side effects.” The same is true of Johnson & Johnson’s. These vaccines are saving countless lives across multiple continents.

‘But it’s also crucial to determine the biological cause of any vaccine-related blood conditions. This global immunization project presents a lot of firsts: the first authorized use of mRNA vaccines like the ones from Pfizer and Moderna; the first worldwide use of adenovirus vectors for vaccines like AstraZeneca’s, Johnson & Johnson’s, and Sputnik V; and the first attempt to immunize against a coronavirus. Which, if any, of these new frontiers might be linked to serious side effects? Which, if any, of the other vaccines could be drawn into this story, too? How can a tiny but disturbing risk be mitigated as we fight our way out of this pandemic? And what might be the implications for vaccine design in the years to come?

‘To answer these questions, scientists will have to figure out the biology behind this rare blood condition: what exactly causes it; when and why it happens. This is not an easy task. While the evidence available so far is fairly limited, some useful theories have emerged...

• Theory 1: Platelet problems
• Theory 2: The spike’s the problem
• Theory 3: A suspect sequence
• Theory 4: The mixed bag

Read here (The Atlantic, Apr 17, 2021)

Three different futures for the Johnson & Johnson vaccine

‘Based on what we know so far, the future of the J&J vaccine can fork in at least three different directions. In one, the vaccine flames out; unless many, many more cases come to light soon, this seems unlikely. Either of the other two—in which officials end the pause and return the nation to its regularly scheduled vaccine programming, with or without restrictions on who gets J&J next—are more likely. No matter the outcome, though, today’s announcement won’t quickly be forgotten. Pauses in clinical trials, sprinkled through the past year, have already stoked vaccine hesitancy, skepticism, and outright denialism in many circles. The Johnson & Johnson vaccine, previously stigmatized for being “less effective,” now risks a second label: “less safe.” It’s on the precipice of becoming our country’s grody vaccine; maybe it’s already toppled over the edge. An altered reputation in the U.S. will reverberate throughout the world, and set back the global struggle to contain the coronavirus.

‘If the J&J vaccine does return with the FDA’s blessing, we’ll need to rehabilitate it with clear and nuanced messaging, Gounder and many others told me. A vaccine can be excellent. A vaccine can also carry risks. Both can be true; both have been true, for other shots we’ve used. In this case, the gamble could be very small—and still be well worth it.’

Read here (The Atlantic, Apr 13, 2021)

AstraZeneca: Is there a blood clot risk?

‘I have spoken to respected scientists some of whom are sceptical, others increasingly convinced. Some point to the highly unusual nature of the clots as a sign something could be going on. They are often appearing at the same time as low levels of blood platelets, which are one of the main components of a clot, and antibodies linked to other clotting disorders appearing in the blood. Others say there is not enough proof and the reported cases could plausibly be down to Covid, which itself is linked to abnormal clotting.’

Read here (BBC, Apr 3, 2021)

Thromboembolism and the Oxford–AstraZeneca COVID-19 vaccine: Side-effect or coincidence?

‘When making decisions on the use of drugs based on pharmacovigilance, it is important to take into account the natural incidence of illnesses, such as venous thromboembolisms, that might be interpreted as serious adverse events. Here, based on pre-pandemic incidence rates from the entire Danish population, we report that the number of venous thromboembolisms reported in relation to the Oxford–AstraZeneca COVID-19 vaccine does not seem to be increased beyond the expected incidence rate. Nevertheless, recent reports of thrombocytopenia-associated cerebral venous sinus thrombosis, multiple thrombosis, and bleeding within a short timeframe after receipt of the vaccine are concerning and are receiving due attention from health authorities. On March 18, 2021, with reference to the Oxford–AstraZeneca COVID-19 vaccine, the EMA concluded that “benefits still outweigh the risks despite possible link to rare blood clots with low blood platelets”.’

Read here (The Lancet, Mar 30, 2021) 

EU states to resume AstraZeneca vaccine rollout

‘The EU's leading states are to restart their roll-out of the Oxford-AstraZeneca Covid-19 vaccine after Europe's medicines regulator concluded it was "safe and effective". The European Medicines Agency (EMA) reviewed the jab after 13 EU states suspended use of the vaccine over fears of a link to blood clots. It found the jab was "not associated" with a higher risk of clots. Germany, France, Italy and Spain said they would resume using the jab.’

Read here (BBC, Mar 19, 2021)

Without official vaccine guidance, pregnant people are left to do their own research

‘The lack of clear guidance around pregnancy has ripple effects. Despite abundant evidence that the vaccines are safe for lactating parents and their babies, last month the Chicago Tribune reported that a new mom who was breastfeeding was denied the COVID-19 vaccine by her county’s health department. Officials said they decided not to allow pregnant or lactating women to receive the vaccine, citing a lack of data.

‘Dr. Peter Hotez, a vaccinologist and dean of the National School of Tropical Medicine at Baylor College of Medicine, told me he was appalled by the mixed messaging around vaccines in pregnancy, which he said leaves patients “reading the tea leaves.” The government “has not made a good faith effort to take down the anti-vaccine misinformation and disinformation,” he said. “So by telling a pregnant woman to do her own research online means you’re basically telling her not to get vaccinated.”

Read here (Mother Jones, Mar 4, 2021)

I have allergies – Can I take the Covid-19 vaccine? — Dr Amar-Singh HSS

‘I believe there are three possible options for those of us with severe allergies:

• We may choose not to get vaccinated as we feel the risk is too high. But we will have to accept a much stricter SOP for our lives and be prepared to have our lives restricted for some time.
• The second option is that we choose to vaccinate and, due to the high risk, ask that it be done with enhanced health professional support, i.e. vaccinate in a hospital and have good backup with adrenaline at hand.
• The third option is to delay vaccination and watch the data as more is made available. The risk of anaphylaxis is small and likely to be even smaller as we get more vaccination data. We will also have a clearer idea which vaccine has the lowest rate of severe allergic reaction. Once this data is available we hope to be able to choose the least allergic vaccine and vaccinate in a hospital with good physician backup.’

Read here (Code Blue, Mar 1, 2021)

Synthetic mRNA Covid vaccines: A risk-benefit analysis

‘With a “vaccine” based on untested technology, and safety trials still ongoing, is it safe to take the shot? And does it even work? And does a disease with an IFR of 0.2% even justify that risk?’

Read here (Off Guardian, Feb 22, 2021)

Experts answer the biggest Covid vaccine questions

‘The lack of informed messaging from the Trump administration, combined with the range of different COVID vaccines, the emergence of new coronavirus variants, and inconsistent state and municipal rollout plans, have caused confusion and driven vaccine hesitancy. Scientific American asked Namandjé Bumpus, a pharmacologist at Johns Hopkins Medicine in Baltimore, and Ashley Lauren St. John, an immunologist at Duke-NUS Medical School in Singapore to answer some of the biggest questions about the currently available COVID vaccines:

• Should you get an authorized COVID vaccine now if you are eligible?
• Should you get vaccinated if you have already had COVID?
• How should you interpret vaccine efficacy—what does “95 percent efficacy” or “66 percent efficacy” even mean?
• If you get the vaccine and still get infected, does the vaccine still make a difference? 
• Will it prevent severe disease or death?
• Do the vaccines protect against the new virus variants, including those first identified in the U.K., South Africa and Brazil?
• What is the difference between mRNA and viral vector vaccines?
• Is there a “best” vaccine?
• Will the vaccine protect you from giving the virus to others?
• Will the vaccine’s effectiveness “wear off” over time?
• Should you be worried about allergic reactions to the vaccine?
• How can you ensure you’re getting a legitimate, authorized vaccine?

Read here (Scientific American, Feb 19, 2021)

Sensationalising, misrepresenting facts does disservice to people: Jeyakumar Devaraj

‘Yesterday morning, I came across an article titled “UK Government releases shocking report on Covid vaccine side effects” in one of the WhatsApp chat groups I am in. This article by dailyexpose.co.uk, dated 9 February 2021, states that 70,500 adverse reactions were reported in the 6.9 million people vaccinated in the UK between 8 December 2020 and 24 January 2021.

‘The article says five people went blind, 21 suffered strokes, 69 developed facial nerve weakness (Bell’s Palsy) and 107 died because of the Covid vaccine they received.

‘This is a terribly unscientific way of looking at the data. People get sick, suffer various maladies and die even when not vaccinated. So, we need to check whether the incidence of each of these adverse events is actually higher in the vaccinated cohort when compared to the baseline figures for that population. If it is, then it could be possible that the vaccine predisposes to these conditions, and we would have to look more closely.

‘Let’s take the deaths first. According to the UK Office for National Registration, in 2019 there were 1,079.4 deaths per 100,000 males and 798.9 deaths per 100,000 females – over the whole year.

‘The 107 deaths observed in the 6.9 million vaccinated individuals gives a mortality rate of 1.6 per 100,000 – over seven weeks. If we annualise it by multiplying 1.6 by 52 and dividing it by 7, we arrive at a figure of 11.5 per 100,000 – much lower than the UK Crude Death Rate (CDR) for 2019 (CDR = overall death rate without breaking it down into death rates for each age group). These figures indicate that it would be difficult to sustain an argument that the Covid vaccine increases the risk of dying in the UK population.’

Read here (Aliran, Feb 15, 2021)

The second Covid-19 shot is a rude reawakening for immune cells

‘Side effects are just a sign that protection is kicking in as it should...

‘At about 2 a.m. on Thursday morning, I woke to find my husband shivering beside me. For hours, he had been tossing in bed, exhausted but unable to sleep, nursing chills, a fever, and an agonizingly sore left arm. His teeth chattered. His forehead was freckled with sweat. And as I lay next to him, cinching blanket after blanket around his arms, I felt an immense sense of relief. All this misery was a sign that the immune cells in his body had been riled up by the second shot of a COVID-19 vaccine, and were well on their way to guarding him from future disease.

‘Side effects are a natural part of the vaccination process, as my colleague Sarah Zhang has written. Not everyone will experience them. But the two COVID-19 vaccines cleared for emergency use in the United States, made by Pfizer/BioNTech and Moderna, already have reputations for raising the hackles of the immune system: In both companies’ clinical trials, at least a third of the volunteers ended up with symptoms such as headaches and fatigue; fevers like my husband’s were less common.

‘Dose No. 2 is more likely to pack a punch—in large part because the effects of the second shot build iteratively on the first. My husband, who’s a neurologist at Yale New Haven Hospital, is one of many who had a worse experience with his second shot than his first.’

Read here (The Atlantic, Feb 2, 2021)

Sputnik V ‘91·6% efficacious, well tolerated’: Safety and efficacy of an rAd26 and rAd5 vector-based heterologous prime-boost COVID-19 vaccine: an interim analysis of a randomised controlled phase 3 trial in Russia

‘Our interim results of the phase 3 Gam-COVID-Vac trial show that the vaccine is 91·6% (95% CI 85·6–95·2) efficacious against COVID-19 (from day 21 after first dose, the day of receiving second dose). Our results also showed that the vaccine was 100% (95% CI 94·4–100) efficacious against severe COVID-19, although this was a secondary outcome so the results are preliminary. The vaccine was well tolerated, with 45 (0·3%) of 16 427 participants in the vaccine group reporting serious adverse events, all of which were considered not related to the vaccine... 

‘The vaccine induced robust humoral (n=342) and cellular (n=44) immune responses in all age strata. Notably, there were a few non-responders in the vaccine group (six of 342), possibly due to immunosenescence in older people, individual characteristics of the formation of an immune response, or concomitant immunological disorders.’

Read here (The Lancet, Feb 2, 2021) 

Norway moves to calm vaccine anxiety after elderly deaths

‘Health authorities in Norway sought to allay safety concerns raised by the death of some elderly patients after they were vaccinated against Covid-19, saying there’s no evidence of a direct link.

‘The initial reports from Norway raised alarm as the world looks for early signs of potential side effects from the vaccines. Although doctors say it’s possible that vaccine side-effects could aggravate underlying illnesses, they were expecting nursing-home residents to die shortly after being vaccinated because deaths are more common among the frailest and sickest elderly patients.

“Clearly, Covid-19 is far more dangerous to most patients than vaccination,” Steinar Madsen, medical director at the Norwegian Medicines Agency, said by phone on Monday, adding that a connection between the vaccine and the deaths is difficult to prove. “We are not alarmed.”

Read here (Bloomberg, Jan 18, 2021)

Correcting misleading information by Western media on Chinese vaccines responsible measure in global pandemic fight

‘Fair reporting of allergic events and side effects from both Chinese vaccines and Pfizer’s vaccines is of great significance. The biased reports by Western media outlets have made the Chinese vaccine like a boat sailing against the current in the international public opinion arena. It is not only unfair, but also harmful to the global fight against the pandemic. The Global Times has the obligation to correct the environment of public opinion created by misinformation from Western media and do our part to promote the fairness of public perceptions regarding different vaccines.’

Read here (Global Times, Jan 16, 2021)

Chinese health experts call to suspend Pfizer's mRNA vaccine for elderly after Norwegian deaths

‘Chinese health experts called on Norway and other countries to suspend the use of mRNA-based COVID-19 vaccines produced by companies such as Pfizer, especially among elderly people, due to the vaccines' safety uncertainties following the deaths of 23 elderly Norwegian people who received the vaccine. 

‘The new mRNA vaccine was developed in haste and had never been used on a large scale for the prevention of infectious disease, and its safety had not been confirmed for large-scale use in humans, a Chinese immunologist said. The death incidents in Norway also proved that the mRNA COVID-19 vaccines' efficacy was not as good as expected, experts said. 

‘As of Thursday, Norway has reported 23 deaths in connection with vaccination."So far, 13 of these have been assessed. Common side effects may have contributed to a severe course in frail elderly people," the Norwegian Medicines Agency said on its website. All the deaths have occurred in frail, elderly patients in nursing homes. All are over 80 years old and some of them over 90, Norwegian media NRK reported.’

Read here (Global Times, Jan 15, 2021)

Covid-19 is dangerous, not vaccines — 20 scientists, doctors, and concerned individuals

‘Statements propagating fear-mongering and pseudoscience that attack Covid-19 vaccines’ mRNA (messenger RNA) technologies – which have now been approved by the US’ Food and Drug Administration, the UK’s Medicines and Healthcare Products Regulatory Agency, the European Medicines Agency, and the regulatory bodies of at least seven other countries – risk turning Malaysians off all Covid-19 vaccines entirely, as some may not differentiate between one type of Covid-19 vaccine with another. mRNA and vector-based therapies have actually been used for nearly a decade to treat people with cancer, inherited immunodeficiencies, and metabolic, eye, and neuro-muscular diseases.’

Read here (Code Blue, Jan 4, 2021)

Covid-19 vaccines for Malaysia: A call for transparency in registration & purchasing

By Citizens’ Health Initiative (citizenhealthinitiative@gmail.com)

With the exception of the People’s Republic of China and a few other countries like New Zealand, Vietnam, Cuba, Senegal, and Kerala state in India, which seem to have largely brought Covid-19 under control without the help of vaccines, most countries are struggling with succeeding waves of the pandemic and a likely global spread of a more contagious mutant of SARS-CoV-2.  

The collateral damage to economic and social well-being worldwide has been unprecedented, and it underscores the urgently felt need for vaccines and a return to some semblance of normalcy.

Despite a major lapse with a 16,000 plus person religious gathering which erupted into several clusters locally and in the region (March 2020), Malaysia had performed creditably earlier.

Sources of current outbreaks

Unfortunately, since October 2020, a resurgence of clusters emerged from non-compliant returnees from abroad, and porous Sabah state border controls, exacerbated by lax enforcement of SOPs during the September 2020 Sabah state elections. 

Immigration and health authorities were not sufficiently pro-active to prevent its further spread in the peninsula, resulting in numerous outbreaks, especially among workers in congested accommodations and workplaces, and in prisons and detention centres.

Unlike Singapore’s experience with outbreaks in migrant dormitory complexes, we in Malaysia are additionally reaping the consequences of decades of corrupt mismanagement of labor migration, viz. a persistently large pool of undocumented migrant workers (currently estimated at 1.2-1.5 million) who have strong incentives to avoid contact with government agencies.   

Senior Minister Ismail Sabri’s disastrous U-turn in going after undocumented migrants (after initially promising them sanctuary and no arrests and deportation during the pandemic) greatly complicated pandemic control efforts, in particular the crucially important contact tracing.

As generally younger daily-paid workers, more likely to ride out the milder symptoms of Covid-19 infection, they are now even less inclined to cooperate in testing and isolation, given the risks of arrest, detention and deportation.

\We thus face the prospect of protracted and repeated seeding of the general population by the asymptomatic or mildly symptomatic, especially undocumented workers reluctant to seek treatment unless severely ill. (We should also note that active avoidance of contact tracing and testing involves others disinclined to divulge network contacts or contact history, e.g. underworld elements, drug and sexual encounters, etc).

As in many other countries, many Malaysians support efforts to secure vaccines to enhance pandemic control efforts.

Procuring vaccines for Malaysia

The minister for Science, Technology, and Innovation Khairy Jamaluddin has announced commitments to purchase a basket of Covid-19 vaccines, and options for further orders .

Khairy Jamaluddin needs to be transparent about the technical rationales, criteria, and pricing for his ministry’s purchasing decisions.  In particular, he needs to respond to very pertinent points raised by the Covid Research Centre (KL) , chest specialist Dr Jeyakumar Devaraj , and others, which include the following:

• there is currently little information on long-term safety beyond 2 months or on durability of protection, for all candidate or approved vaccines (any late-manifesting adverse effects will only be detected by conscientious follow-up surveillance, monitoring, and reporting systems).  This is especially pertinent for novel mRNA vaccines, in comparison with the more familiar inactivated whole-virus vaccines with which we have decades of experience
• the decision by the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) to grant immunity to Pfizer from legal liability for late-manifesting adverse effects, and the Pfizer CEO declining to be among the early vaccinees (claiming selflessness in prioritising those more vulnerable, in contrast to some vaccine researchers who vaccinated themselves even before phase 1 human trials) perhaps reflects the true risk perception or assessment of the pharmaceutical corporations (whose profitable research and development work has been highly subsidised by governments for ‘vaccine nationalist’ reasons)
• stringent logistic requirements (deep-freeze or ultra-low temperature facilities) for the mass deployment of mRNA vaccines to under-served remote areas
• one additional advantage of the inactivated whole-virus vaccine is that the host immune response is mounted against a spectrum of antigens from the whole virus, rather than against a much more limited array of antigenic sub-components of say, the spike protein.  This could provide some insurance against mutations, say in the coding sequences for the spike protein, which might render vaccines directed solely against the spike protein wholly or partially ineffective.

Beyond the immediate urgency of securing access to adequate quantities of safe, efficacious and affordable vaccines, the larger question of our continuing dependency on foreign vaccine developers, producers and suppliers remains unaddressed.

National capabilities in production of medicines and vaccines

Consider Cuba, a nation of 12 million citizens hamstrung by a 60-year economic blockade by the US, which has invested in human and material resources to become a biotech power-house:  recombinant hepatitis B vaccines, synthetic polysaccharide vaccine against Haemophilus influenzae type B , CIMAvax vaccine against lung cancer , and innovative treatment of diabetic foot ulcers.

Cuba’s repeated offers of scientific collaboration in R&D, and joint ventures to position Malaysia as a regional production and distribution platform for Southeast Asia , have elicited only a lukewarm response.  Tan Sri Dr Abu Bakar Suleiman, the retired Director General of Health, has shown greater foresight and entrepreneurial verve as chairman of Bioven , which is shepherding CIMAvax through US-FDA and UK phase 3 clinical trials .

It is not too late to make the necessary strategic decisions for a promising growth area (pharmaceuticals and vaccines) in the national and regional economies of the newly launched RCEP.

For more information/clarifications, please contact:

• Chan Chee Khoon     cheekhoon50@gmail.com 
• Chee Heng Leng        cheehengleng@gmail.com 

Endorsers

• Aliran
• Citizens’ Health Initiative
• Freedom
• Kuala Lumpur & Selangor Chinese Assembly Hall (KLSCAH) 
• Malaysian Physicians for Social Responsibility (MPSR)
• North South Initiative
• Pengguna Pahang
• Parti Sosialis Malaysia (PSM)
• Pergerakan Tenaga Akademik Malaysia (GERAK)
• Suara Rakyat Malaysia (SUARAM)
•  Childline Foundation

Covid-19 vaccine: Hold your horses, let us play safe! Jeyakumar Devaraj

• Malaysia should rely on old tech vaccines comprise of viral proteins. Let us not experiment on our population with the “sophisticated” vaccines that use RNA and DNA technology.
• Offer the old tech COVID-19 vaccines to the high risk groups initially, and then later to the entire population. But do not make it mandatory for any particular group. Let people make an informed choice.
• Provide clear information to the public. We should be honest with our people. The authorities should also tell the people that at present we do not have data regarding long term safety of the RNA and DNA vaccines.
• Provide the old tech COVID-19 vaccine free to the population.
• Conduct post COVID-19 vaccination surveillance to obtain an accurate estimate of side effects arising from the vaccines.
• It is high time for civil society groups and concerned individuals to voice up and urge for a cautious and measured approach to the mass vaccination of the Malaysian public.

Read here (Focus Malaysia, Dec 24, 2020)